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Oxytocin or Galantamine Versus Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia

Oxytocin or Galantamine vs. Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01012167
Acronym
CIDAR-3
Enrollment
86
Registered
2009-11-11
Start date
2010-02-28
Completion date
2014-07-31
Last updated
2022-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia, oxytocin, galantamine

Brief summary

The project is designed to address the following two primary aims: 1. To determine whether adjunctive oxytocin is superior to placebo for the treatment of persistent negative symptoms, as measured by the SANS total score, in people with schizophrenia. 2. To determine whether adjunctive Galantamine is superior to placebo for the treatment of cognitive impairments, as measured by improvement on a composite neurocognitive score in people with schizophrenia. The investigators will also address the following secondary aims: 1. To determine whether people with schizophrenia treated with adjunctive oxytocin, compared to placebo, will show greater improvement on markers of negative symptom liability including: social affiliation, facial affect recognition, olfactory discrimination, initiation of smooth pursuit and latency of internally-driven saccades. 2. To determine whether people with schizophrenia treated with adjunctive Galantamine, compared to placebo, will show greater improvement on markers of cognitive impairment liability including: predictive pursuit, P50 sensory gating and visual-spatial working memory. The investigators will address the following exploratory aims: 1. To determine whether changes in markers of negative symptom liability are correlated with changes in SANS total score. 2. To determine whether changes in markers of cognitive impairment liability are correlated with changes in the composite neurocognitive score. 3. To determine the response to oxytocin of all cognition domains assessed by the MATRICS battery, and to determine the response to Galantamine of all cognition domains assessed by the MATRICS, which are not included in the primary neurocognitive outcome score. 4. To determine whether there is a differential response of oxytocin and Galantamine on the SANS total score, composite neurocognitive score, and with the phenotypic measures of negative symptom and cognitive impairment liability. 5. To determine whether oxytocin and Galantamine are associated with: * adverse effects on positive or depressive symptoms; * adverse effects on motor symptoms; * adverse effects on laboratory and EKG measures; * increased occurrence of side effects; * social interest that is independent of sexual desire.

Interventions

DRUGOxytocin

Oxytocin: 24 IU in the morning and 24 IU in the evening given by nasal spray with a total of 6 puffs of the spray, 3 in each nostril at each administration

DRUGGalantamine

Galantamine: 4 mg twice a day for 1 week, then 8 mg twice a day for 1 week, then 12 mg twice a day for 4 weeks

OTHERPlacebo-Oxytocin

Saline nasal spray with a total of 6 puffs of the spray, 3 in each nostril at each administration

OTHERPlacebo-Galantamine

Placebo tablets twice a day for 6 weeks

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

* Any race * Subjects will meet DSM-IV criteria for schizophrenia or schizoaffective disorder * Judged clinically stable and will not exceed threshold levels of positive, depressive, and/or extrapyramidal symptoms * The minimum level of negative symptoms will be defined as follows: * Scale for the Assessment of Negative Symptoms (SANS) total score (minus the global items, and inappropriate affect, poverty of content of speech and attentional items) 20 or greater; OR * SANS alogia global item score 3 or greater * The maximum level of psychotic, depressive, and extrapyramidal symptoms at the beginning and end of leading in: * Brief Psychiatric Rating Scale (BPRS) psychotic factor score (4-items) less or equal to 16 * BPRS Anxiety/Depression factor score (4-items) less than or equal to 14 * Simpson-Angus-Scale (SAS) total score (13-items) less than or equal to 10 * Subjects will be required to be on the same antipsychotic(s) for two months and on the same dose for the last month

Exclusion criteria

* Participants with an organic brain disorder; mental retardation; or a medical condition, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol * Participants with intermittent alcohol or substance use will not be excluded unless they have met DSM-IV criteria for alcohol or substance abuse (other than nicotine) within the last month. * Participants may be treated with one or more antipsychotics, except chlorpromazine, thioridazine, or mesoridazine. These latter antipsychotics are excluded because of the concern that their anticholinergic properties may interfere with the accurate assessment of galantamine efficacy. * Participants may not be treated with anticholinergic medications or have clinically significant extrapyramidal symptoms. Additionally, subjects treated with glycopyrrolate will be accepted. * Female participants may not be pregnant * Female subjects may not be taking olanzapine at doses higher than 30 mg . Male subjects may not be taking olanzapine at doses higher than 40 mg.

Design outcomes

Primary

MeasureTime frameDescription
Scale for the Assessment of Negative Symptoms (SANS) Total ScoreEvery other week for 6 weeksMean SANS Total Score by Treatment and Week. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.
Mean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and WeekTreatment Week 0 and Week 6\* Composite Cognitive Primary Outcome = mean of z-scores from the Brief Assessment of Cognition in Schizophrenia (BACS) Symbol Digit test, the Hopkins Verbal Learning Test (HVLT), and the Rapid Visual Information Processing test (RVIP). Z-scores for each test were calculated as Z = (individual patient score - pooled baseline mean)/(pooled baseline standard deviation). Higher values of the composite score represent a better outcome.

Secondary

MeasureTime frameDescription
Scale for the Assessment of Negative Symptoms (SANS) - AlogiaEvery other week for 6 weeksMean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.
Scale for the Assessment of Negative Symptoms (SANS) - Blunted AffectEvery other week for 6 weeksMean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.
Brief Psychiatric Rating Scale (BPRS) - Total ScoreEvery other week for 6 weeksThe total BPRS score is calculated by adding the scores for scales #1-#18. Each scale ranges from 1=Not Present to 7=Very Severe. Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating.
Brief Psychiatric Rating Scale (BPRS) - Psychosis ScoreEvery other week for 6 weeksThe psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating.
Calgary Depression Scale (CDS) - Total ScoreEvery other week for 6 weeksTotal score calculated by adding scores for scales #1-#9. Each scale ranges from 0=Absent to 3=Severe. The minimum total CDS score is 0 and the maximum total CDS score is 27. A higher score indicates a more severe depression rating.
Arizona Sexual Experience Questionnaire (ASEX) FemaleOnce during evaluation and once at the end of 6 weeks of study treatmentMean ASEX total scores by treatment and week for female participants. Total scores are calculated by adding scores for scales #1-#5. Each scale ranges from 1=Easily/Extremely to 6=Never/None. The minimum total ASEX score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences.
Arizona Sexual Experience Questionnaire (ASEX) MaleOnce during evaluation and once at the end of 6 weeks of study treatmentMean ASEX total scores by treatment and week for male participants. Total scores are calculated by adding scores for scales #1-#5. Total scores are calculated by adding scores for scales #1-#5. Each scale ranges from 1=Easily/Extremely to 6=Never/None. The minimum total ASEX score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences.
Vital Signs - Diastolic Blood PressureWeekly for 6 weeksMean diastolic blood pressure by treatment and follow-up week
Vital Signs - Systolic Blood PressureWeekly for 6 weeksMean systolic blood pressure by treatment and follow-up week
Vital Signs - WeightWeekly for 6 weeksMean weight (kg) by treatment and follow-up week
Vital Signs - PulseWeekly for 6 weeksMean sitting pulse (bpm) by treatment and follow-up week
Simpson-Angus Scale (SAS)Baseline, week 3, and week 6SAS total score for extrapyramidal side effects: Frequencies of greatest within-participant increase (worsening) from pre-treatment baseline, by treatment group. Total scores calculated by adding scores from scales #1-#11. Each scale ranges from 0=None/Normal to 4=Extreme/Severe. The minimum total score is 0 and the maximum score is 44. Higher scores indicate a more severe extrapyramidal side effect rating.
Abnormal Involuntary Movement Scale (AIMS)Treatment Week 0 and Week 6AIMS Total Score: Frequencies of Maximum Within- Participant Increases (worsening) from Baseline by Treatment Group. Total score calculated by adding scores from scales #1-#10. Each scale ranges from 0=None to 4=Severe. The minimum total AIMS score is 0 and the maximum score is 40. Higher scores indicate a more severe abnormal involuntary movement rating.
Electrocardiogram (EKG)Once during Evaluation and once at Treatment Week 6Mean corrected QT interval (QTc) by study week and treatment.
Barnes Akathisia Scale (BAS) - Global ScoreTreatment Week 0 and Week 6For each subject, the largest increase from baseline in the global akathisia score at any visit during follow-up was calculated. The global akathisia score ranges from 0=Absent to 5=Severe Akathisia. Higher scores indicate a more severe global rating of akathisia.
Blood Oxytocin LevelsTreatment Week 0 and Week 6Blood Oxytocin Levels by Treatment and Visit
Laboratory Measures - ALT/SGPTOnce during evaluation and once at the end of 6 weeks of study treatmentAlanine transaminase/serum glutamic-pyruvic transaminase (ALT/SGPT) blood levels by treatment group and visit.
Laboratory Measures - AST/SGOTOnce during evaluation and once at the end of 6 weeks of study treatmentAspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) blood levels by treatment group and visit.
Laboratory Measures - Alkaline PhosphataseOnce during evaluation and once at the end of 6 weeks of study treatmentAlkaline phosphatase blood level by treatment group and visit.
Laboratory Measures - CalciumOnce during evaluation and once at the end of 6 weeks of study treatmentCalcium blood levels by treatment group and visit.
Laboratory Measures - SodiumOnce during evaluation and once at the end of 6 weeks of study treatmentSodium blood levels by treatment group and visit.
Laboratory Measures - PotassiumOnce during evaluation and once at the end of 6 weeks of study treatmentPotassium blood levels by treatment group and visit.
Laboratory Measures - ChlorideOnce during evaluation and once at the end of 6 weeks of study treatmentChloride blood levels by treatment group and visit.
Laboratory Measures - CO2Once during evaluation and once at the end of 6 weeks of study treatmentCarbon Dioxide (CO2) blood levels by treatment group and visit.
Laboratory Measures - CholesterolOnce during evaluation and once at the end of 6 weeks of study treatmentTotal cholesterol blood levels by treatment group and visit.
Laboratory Measures - HDLOnce during evaluation and once at the end of 6 weeks of study treatmentHigh-density lipoprotein (HDL) blood levels by treatment group and visit.
Laboratory Measures - LDLOnce during evaluation and once at the end of 6 weeks of study treatmentLow-density lipoprotein (LDL) blood levels by treatment group and visit.
Laboratory Measures - TriglyceridesOnce during evaluation and once at the end of 6 weeks of study treatmentTriglyceride blood levels by treatment group and visit.
Laboratory Measures - VLDLOnce during evaluation and once at the end of 6 weeks of study treatmentVery low density lipoprotein (VLDL) blood levels by treatment group and visit.
Laboratory Measures - GlucoseOnce during evaluation and once at the end of 6 weeks of study treatmentGlucose blood levels by treatment group and visit.
Laboratory Measures - AlbuminOnce during evaluation and once at the end of 6 weeks of study treatmentAlbumin blood levels by treatment group and visit.
Laboratory Measures - GlobulinOnce during evaluation and once at the end of 6 weeks of study treatmentGlobulin blood levels by treatment group and visit.
Laboratory Measures - A/G RatioOnce during evaluation and once at the end of 6 weeks of study treatmentAlbumin to Globulin (A/G) ratio in the blood by treatment group and visit.
Laboratory Measures - BilirubinOnce during evaluation and once at the end of 6 weeks of study treatmentBilirubin blood level by treatment group and visit.
Laboratory Measures - ProteinOnce during evaluation and once at the end of 6 weeks of study treatmentProtein blood level by treatment group and visit.
Laboratory Measures - BUNOnce during evaluation and once at the end of 6 weeks of study treatmentBUN blood level by treatment group and visit.
Side Effect Checklist (SEC) - Abdominal PainWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Abdominal Pain rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - AnorexiaWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Anorexia rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - Bruising EasilyWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Bruising Easily rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - ConstipationWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Constipation rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - DiarrheaWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Diarrhea rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - DizzinessWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Dizziness rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - Dry EyeWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Dry Eye rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - Dry MouthWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Dry Mouth rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - EnuresisWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Enuresis rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - Excessive Tearing of the EyeWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Excessive Tearing of the Eye rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - FeverWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Fever rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - HeadacheWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Headache rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - HyperhydrosisWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Hyperhydrosis rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - HypersalivationWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Hypersalivation rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - InsomniaWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Insomnia rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - MalaiseWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Malaise rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - Mucosal UlcerationWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Mucosal Ulceration rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - Nasal IrritationWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Nasal Irritation rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - NauseaWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Nausea rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - RashWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Rash rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - RestlessnessWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Restlessness rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - SedationWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Sedation rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - Sore ThroatWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Sore Throat rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - StiffnessWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Stiffness rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - TinnitusWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Tinnitus rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - TremorWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Tremor rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - UrticariaWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Urticaria rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - Uterine ContractionsWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Uterine Contractions rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - VomitingWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Vomiting rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - Weight LossWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Weight Loss rating on the SEC, by Treatment Group.
Side Effect Checklist (SEC) - WheezingWeekly for 6 weeksPercentage of participants with new onset or worsening compared to baseline of Wheezing rating on the SEC, by Treatment Group.
Neurocognitive Assessment Battery (MCCB) - Composite ScoreOnce at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).MCCB Composite Score by Week ranging from -10-100 with a higher score indicating a better outcome.
Neurocognitive Assessment Battery (MCCB) - Attention VigilanceOnce at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).MCCB Attention Vigilance domain score by week calculated from the Continuous Performance Test, Identical Pairs version. The domain score scale is 20-80, with higher scores indicating a better outcome. .
Neurocognitive Assessment Battery (MCCB) - Processing SpeedOnce at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).MCCB Processing Speed domain score by week calculated from the Trail Making Test- Part A, Brief Assessment of Cognition in Schizophrenia- symbol coding subtest, and the Category fluency test- animal naming. The domain score scale is 20-80, with higher scores indicating a better outcome.
Scale for the Assessment of Negative Symptoms (SANS) - AvolitionEvery other week for 6 weeksMean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.
Neurocognitive Assessment Battery (MCCB) - Social CognitionOnce at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).MCCB Social Cognition domain score by week calculated from the Mayer-Salovey-Caruso Emotional Intelligence Test- managing emotions branch. The domain score scale is 20-80, with higher scores indicating a better outcome.
Neurocognitive Assessment Battery (MCCB) - Verbal LearningOnce at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).MCCB Verbal Learning domain score by week calculated from the Hopkins Verbal Learning Test-Revised, immediate recall (three learning trials only). The domain score scale is 20-80, with higher scores indicating a better outcome.
Neurocognitive Assessment Battery (MCCB) - Visual LearningOnce at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).MCCB Visual Learning domain score by week calculated from the Brief Visuospatial Memory Test-Revised. The domain score scale is 20-80, with higher scores indicating a better outcome.
Neurocognitive Assessment Battery (MCCB) - Working MemoryOnce at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).MCCB Working Memory domain score by week calculated from the Wechsler Memory Scale, 3rd ed., spatial span subtest. The domain score scale is 20-80, with higher scores indicating a better outcome.
Positive and Negative Affect Schedule (PANAS) - NegativeTreatment Week 0 and Week 6Participant reported responses after Brief Role Play rating how they felt during the role plays. Participants rated 12 negative affect items on a scale of 1-5, with 1 being very slightly or not at all and 5 being extremely. The minimum score for this measure is 12 and the maximum score is 60. Higher scores indicate a higher rate of negative affect during the role plays.
Positive and Negative Affect Schedule (PANAS) - PositiveTreatment Week 0 and Week 6Participant reported responses after Brief Role Play rating how they felt during the role plays. Participants rated 12 positive affect items on a scale of 1-5, with 1 being very slightly or not at all and 5 being extremely. The minimum score for this measure is 12 and the maximum score is 60. Higher scores indicate a higher rate of positive affect during the role plays.
Reactions to PartnerTreatment Week 0 and Week 6Participant reported responses after Brief Role Play. The Reactions to Partner item was calculated by totaling responses to 7 scales. Each scale score ranges from 1-5, which 1 being completely agree and 5 being completely disagree. The minimum score for this measure is 7 and the maximum score is 35. Higher responses indicate a more negative reaction to their role play partner.
Willingness to InteractTreatment Week 0 and Week 6Participant reported responses after Brief Role Play. The Willingness to Interact item calculated by totaling scores from items 1-6. Each score ranges from 1-5, with 1 being definitely willing and 5 being definitely unwilling. The minimum score for this measure is 6 and the maximum score is 30. Lower scores indicate more willingness to interact with their role play partner again in the future.
Neurocognitive Assessment Battery (MCCB) - Reasoning/Problem SolvingOnce at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).MCCB Reasoning/Problem Solving domain score by week calculated from the Neuropsychological Assessment Battery- mazes subtest. The domain score scale is 20-80, with higher scores indicating a better outcome.
Scale for the Assessment of Negative Symptoms (SANS) - AnhedoniaEvery other week for 6 weeksMean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.

Countries

United States

Participant flow

Pre-assignment details

Consented/Screened for Study-- N=86 Withdrew prior to randomization (N=28) * 2 withdrew consent * 26 did not meet inclusion criteria Randomized-- N=58

Participants by arm

ArmCount
1: Oxytocin
Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks
16
2: Galantamine
Galantamine or placebo Galantamine: Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks.
20
3: Placebo
Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day.
20
Total56

Baseline characteristics

CharacteristicTotal1: Oxytocin2: Galantamine3: Placebo
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
56 Participants16 Participants20 Participants20 Participants
Age, Continuous44.9 years
STANDARD_DEVIATION 11.8
47.4 years
STANDARD_DEVIATION 11.2
45.8 years
STANDARD_DEVIATION 12.4
42.2 years
STANDARD_DEVIATION 11.7
Region of Enrollment
United States
56 participants16 participants20 participants20 participants
Sex: Female, Male
Female
11 Participants2 Participants6 Participants3 Participants
Sex: Female, Male
Male
45 Participants14 Participants14 Participants17 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
4 / 171 / 200 / 21
serious
Total, serious adverse events
0 / 171 / 200 / 21

Outcome results

Primary

Mean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and Week

\* Composite Cognitive Primary Outcome = mean of z-scores from the Brief Assessment of Cognition in Schizophrenia (BACS) Symbol Digit test, the Hopkins Verbal Learning Test (HVLT), and the Rapid Visual Information Processing test (RVIP). Z-scores for each test were calculated as Z = (individual patient score - pooled baseline mean)/(pooled baseline standard deviation). Higher values of the composite score represent a better outcome.

Time frame: Treatment Week 0 and Week 6

Population: Five subjects were unable to handle the demands of the Rapid Visual Information Processing (RVIP) test, part of the composite primary outcome measure, and did not provide valid data.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineMean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and WeekTreatment Week 60.33 units on a scaleStandard Deviation 1
1: Oxytocin/Placebo-galantamineMean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and WeekTreatment Week 00.23 units on a scaleStandard Deviation 0.92
1: Oxytocin/Placebo-galantamineMean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and WeekChange0.1 units on a scaleStandard Deviation 0.37
2: Galantamine/Placebo-oxytocinMean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and WeekTreatment Week 6-0.05 units on a scaleStandard Deviation 0.68
2: Galantamine/Placebo-oxytocinMean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and WeekTreatment Week 0-0.22 units on a scaleStandard Deviation 0.47
2: Galantamine/Placebo-oxytocinMean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and WeekChange0.17 units on a scaleStandard Deviation 0.44
3: Placebo-galantamine /Placebo-oxytocinMean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and WeekTreatment Week 00.21 units on a scaleStandard Deviation 0.83
3: Placebo-galantamine /Placebo-oxytocinMean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and WeekChange0.03 units on a scaleStandard Deviation 0.41
3: Placebo-galantamine /Placebo-oxytocinMean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and WeekTreatment Week 60.18 units on a scaleStandard Deviation 0.69
Primary

Scale for the Assessment of Negative Symptoms (SANS) Total Score

Mean SANS Total Score by Treatment and Week. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.

Time frame: Every other week for 6 weeks

Population: Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) Total ScoreTreatment Week 230.07 units on a scaleStandard Deviation 6.93
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) Total ScoreChange from Week 0 at Week 2-3.17 units on a scaleStandard Deviation 4.2
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) Total ScoreTreatment Week 631.40 units on a scaleStandard Deviation 6.85
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) Total ScoreTreatment Week 033.23 units on a scaleStandard Deviation 6.91
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) Total ScoreChange from Week 0 at Week 6-1.83 units on a scaleStandard Deviation 3.74
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) Total ScoreChange from Week 0 at Week 4-1.97 units on a scaleStandard Deviation 4.48
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) Total ScoreTreatment Week 431.27 units on a scaleStandard Deviation 7.53
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) Total ScoreTreatment Week 633.22 units on a scaleStandard Deviation 10.64
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) Total ScoreTreatment Week 036.63 units on a scaleStandard Deviation 10.09
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) Total ScoreTreatment Week 235.22 units on a scaleStandard Deviation 10.97
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) Total ScoreTreatment Week 434.06 units on a scaleStandard Deviation 10.26
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) Total ScoreChange from Week 0 at Week 2-1.41 units on a scaleStandard Deviation 3.32
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) Total ScoreChange from Week 0 at Week 4-1.69 units on a scaleStandard Deviation 3.46
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) Total ScoreChange from Week 0 at Week 6-2.53 units on a scaleStandard Deviation 4.34
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) Total ScoreChange from Week 0 at Week 2-1.58 units on a scaleStandard Deviation 4.84
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) Total ScoreTreatment Week 235.05 units on a scaleStandard Deviation 10.52
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) Total ScoreChange from Week 0 at Week 6-1.00 units on a scaleStandard Deviation 4.41
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) Total ScoreChange from Week 0 at Week 4-1.47 units on a scaleStandard Deviation 5.64
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) Total ScoreTreatment Week 633.47 units on a scaleStandard Deviation 8.47
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) Total ScoreTreatment Week 434.22 units on a scaleStandard Deviation 9.61
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) Total ScoreTreatment Week 036.63 units on a scaleStandard Deviation 10.61
Secondary

Abnormal Involuntary Movement Scale (AIMS)

AIMS Total Score: Frequencies of Maximum Within- Participant Increases (worsening) from Baseline by Treatment Group. Total score calculated by adding scores from scales #1-#10. Each scale ranges from 0=None to 4=Severe. The minimum total AIMS score is 0 and the maximum score is 40. Higher scores indicate a more severe abnormal involuntary movement rating.

Time frame: Treatment Week 0 and Week 6

Population: 50 participants who completed the trial.

ArmMeasureGroupValue (NUMBER)
1: Oxytocin/Placebo-galantamineAbnormal Involuntary Movement Scale (AIMS)Worsening of 30 percentage of participants
1: Oxytocin/Placebo-galantamineAbnormal Involuntary Movement Scale (AIMS)Worsening of 26.67 percentage of participants
1: Oxytocin/Placebo-galantamineAbnormal Involuntary Movement Scale (AIMS)No worsening (0)86.67 percentage of participants
1: Oxytocin/Placebo-galantamineAbnormal Involuntary Movement Scale (AIMS)Worsening of 16.67 percentage of participants
1: Oxytocin/Placebo-galantamineAbnormal Involuntary Movement Scale (AIMS)Worsening of 50 percentage of participants
2: Galantamine/Placebo-oxytocinAbnormal Involuntary Movement Scale (AIMS)Worsening of 20 percentage of participants
2: Galantamine/Placebo-oxytocinAbnormal Involuntary Movement Scale (AIMS)No worsening (0)77.78 percentage of participants
2: Galantamine/Placebo-oxytocinAbnormal Involuntary Movement Scale (AIMS)Worsening of 116.67 percentage of participants
2: Galantamine/Placebo-oxytocinAbnormal Involuntary Movement Scale (AIMS)Worsening of 30 percentage of participants
2: Galantamine/Placebo-oxytocinAbnormal Involuntary Movement Scale (AIMS)Worsening of 55.56 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinAbnormal Involuntary Movement Scale (AIMS)Worsening of 50 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinAbnormal Involuntary Movement Scale (AIMS)Worsening of 35.88 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinAbnormal Involuntary Movement Scale (AIMS)No worsening (0)76.47 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinAbnormal Involuntary Movement Scale (AIMS)Worsening of 20 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinAbnormal Involuntary Movement Scale (AIMS)Worsening of 117.65 percentage of participants
Secondary

Arizona Sexual Experience Questionnaire (ASEX) Female

Mean ASEX total scores by treatment and week for female participants. Total scores are calculated by adding scores for scales #1-#5. Each scale ranges from 1=Easily/Extremely to 6=Never/None. The minimum total ASEX score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences.

Time frame: Once during evaluation and once at the end of 6 weeks of study treatment

Population: Female participants who completed at least two weeks follow-up.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineArizona Sexual Experience Questionnaire (ASEX) FemaleTreatment Week 613.5 units on a scaleStandard Deviation 0.7
1: Oxytocin/Placebo-galantamineArizona Sexual Experience Questionnaire (ASEX) FemaleTreatment Week 010.5 units on a scaleStandard Deviation 0.7
1: Oxytocin/Placebo-galantamineArizona Sexual Experience Questionnaire (ASEX) FemaleChange3.0 units on a scaleStandard Deviation 0
2: Galantamine/Placebo-oxytocinArizona Sexual Experience Questionnaire (ASEX) FemaleTreatment Week 619.2 units on a scaleStandard Deviation 9.3
2: Galantamine/Placebo-oxytocinArizona Sexual Experience Questionnaire (ASEX) FemaleTreatment Week 021.2 units on a scaleStandard Deviation 7.6
2: Galantamine/Placebo-oxytocinArizona Sexual Experience Questionnaire (ASEX) FemaleChange-2.0 units on a scaleStandard Deviation 3.5
3: Placebo-galantamine /Placebo-oxytocinArizona Sexual Experience Questionnaire (ASEX) FemaleTreatment Week 029.0 units on a scaleStandard Deviation 1.7
3: Placebo-galantamine /Placebo-oxytocinArizona Sexual Experience Questionnaire (ASEX) FemaleChange0.0 units on a scaleStandard Deviation 0
3: Placebo-galantamine /Placebo-oxytocinArizona Sexual Experience Questionnaire (ASEX) FemaleTreatment Week 630.0 units on a scaleStandard Deviation 0
Secondary

Arizona Sexual Experience Questionnaire (ASEX) Male

Mean ASEX total scores by treatment and week for male participants. Total scores are calculated by adding scores for scales #1-#5. Total scores are calculated by adding scores for scales #1-#5. Each scale ranges from 1=Easily/Extremely to 6=Never/None. The minimum total ASEX score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences.

Time frame: Once during evaluation and once at the end of 6 weeks of study treatment

Population: Male participants who completed at least two weeks follow-up.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineArizona Sexual Experience Questionnaire (ASEX) MaleTreatment Week 617.1 units on a scaleStandard Deviation 8.5
1: Oxytocin/Placebo-galantamineArizona Sexual Experience Questionnaire (ASEX) MaleTreatment Week 016.5 units on a scaleStandard Deviation 9.2
1: Oxytocin/Placebo-galantamineArizona Sexual Experience Questionnaire (ASEX) MaleChange1.5 units on a scaleStandard Deviation 7.8
2: Galantamine/Placebo-oxytocinArizona Sexual Experience Questionnaire (ASEX) MaleTreatment Week 620.2 units on a scaleStandard Deviation 7.5
2: Galantamine/Placebo-oxytocinArizona Sexual Experience Questionnaire (ASEX) MaleTreatment Week 018.1 units on a scaleStandard Deviation 6.7
2: Galantamine/Placebo-oxytocinArizona Sexual Experience Questionnaire (ASEX) MaleChange1.6 units on a scaleStandard Deviation 5
3: Placebo-galantamine /Placebo-oxytocinArizona Sexual Experience Questionnaire (ASEX) MaleTreatment Week 020.8 units on a scaleStandard Deviation 6.3
3: Placebo-galantamine /Placebo-oxytocinArizona Sexual Experience Questionnaire (ASEX) MaleChange0.8 units on a scaleStandard Deviation 6.2
3: Placebo-galantamine /Placebo-oxytocinArizona Sexual Experience Questionnaire (ASEX) MaleTreatment Week 621.7 units on a scaleStandard Deviation 7.7
Secondary

Barnes Akathisia Scale (BAS) - Global Score

For each subject, the largest increase from baseline in the global akathisia score at any visit during follow-up was calculated. The global akathisia score ranges from 0=Absent to 5=Severe Akathisia. Higher scores indicate a more severe global rating of akathisia.

Time frame: Treatment Week 0 and Week 6

Population: 50 participants who completed the trial.

ArmMeasureGroupValue (NUMBER)
1: Oxytocin/Placebo-galantamineBarnes Akathisia Scale (BAS) - Global ScoreNo worsening (0)93.33 percentage of participants
1: Oxytocin/Placebo-galantamineBarnes Akathisia Scale (BAS) - Global ScoreWorsening of 16.67 percentage of participants
2: Galantamine/Placebo-oxytocinBarnes Akathisia Scale (BAS) - Global ScoreNo worsening (0)100 percentage of participants
2: Galantamine/Placebo-oxytocinBarnes Akathisia Scale (BAS) - Global ScoreWorsening of 10 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinBarnes Akathisia Scale (BAS) - Global ScoreNo worsening (0)94.12 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinBarnes Akathisia Scale (BAS) - Global ScoreWorsening of 15.88 percentage of participants
Secondary

Blood Oxytocin Levels

Blood Oxytocin Levels by Treatment and Visit

Time frame: Treatment Week 0 and Week 6

Population: Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineBlood Oxytocin LevelsTreatment Week 617.22 pg/mLStandard Deviation 17.02
1: Oxytocin/Placebo-galantamineBlood Oxytocin LevelsTreatment Week 018.22 pg/mLStandard Deviation 15.52
1: Oxytocin/Placebo-galantamineBlood Oxytocin LevelsChange-1.88 pg/mLStandard Deviation 14.09
2: Galantamine/Placebo-oxytocinBlood Oxytocin LevelsTreatment Week 610.11 pg/mLStandard Deviation 3.42
2: Galantamine/Placebo-oxytocinBlood Oxytocin LevelsTreatment Week 013.76 pg/mLStandard Deviation 6.96
2: Galantamine/Placebo-oxytocinBlood Oxytocin LevelsChange-2.99 pg/mLStandard Deviation 5.2
3: Placebo-galantamine /Placebo-oxytocinBlood Oxytocin LevelsTreatment Week 014.69 pg/mLStandard Deviation 7.99
3: Placebo-galantamine /Placebo-oxytocinBlood Oxytocin LevelsChange-1.73 pg/mLStandard Deviation 3.95
3: Placebo-galantamine /Placebo-oxytocinBlood Oxytocin LevelsTreatment Week 613.21 pg/mLStandard Deviation 9.32
Secondary

Brief Psychiatric Rating Scale (BPRS) - Psychosis Score

The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating.

Time frame: Every other week for 6 weeks

Population: Safety data available for the 56 participants exposed to study treatment.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineBrief Psychiatric Rating Scale (BPRS) - Psychosis ScoreTreatment Week 09.34 units on a scaleStandard Deviation 3.2
1: Oxytocin/Placebo-galantamineBrief Psychiatric Rating Scale (BPRS) - Psychosis ScoreTreatment Week 29.40 units on a scaleStandard Deviation 3.79
1: Oxytocin/Placebo-galantamineBrief Psychiatric Rating Scale (BPRS) - Psychosis ScoreTreatment Week 49.87 units on a scaleStandard Deviation 3.6
1: Oxytocin/Placebo-galantamineBrief Psychiatric Rating Scale (BPRS) - Psychosis ScoreTreatment Week 69.67 units on a scaleStandard Deviation 2.87
2: Galantamine/Placebo-oxytocinBrief Psychiatric Rating Scale (BPRS) - Psychosis ScoreTreatment Week 66.78 units on a scaleStandard Deviation 3.21
2: Galantamine/Placebo-oxytocinBrief Psychiatric Rating Scale (BPRS) - Psychosis ScoreTreatment Week 07.30 units on a scaleStandard Deviation 3.01
2: Galantamine/Placebo-oxytocinBrief Psychiatric Rating Scale (BPRS) - Psychosis ScoreTreatment Week 47.00 units on a scaleStandard Deviation 3.48
2: Galantamine/Placebo-oxytocinBrief Psychiatric Rating Scale (BPRS) - Psychosis ScoreTreatment Week 27.21 units on a scaleStandard Deviation 3.61
3: Placebo-galantamine /Placebo-oxytocinBrief Psychiatric Rating Scale (BPRS) - Psychosis ScoreTreatment Week 67.59 units on a scaleStandard Deviation 4.35
3: Placebo-galantamine /Placebo-oxytocinBrief Psychiatric Rating Scale (BPRS) - Psychosis ScoreTreatment Week 27.90 units on a scaleStandard Deviation 3.86
3: Placebo-galantamine /Placebo-oxytocinBrief Psychiatric Rating Scale (BPRS) - Psychosis ScoreTreatment Week 48.06 units on a scaleStandard Deviation 4.09
3: Placebo-galantamine /Placebo-oxytocinBrief Psychiatric Rating Scale (BPRS) - Psychosis ScoreTreatment Week 08.18 units on a scaleStandard Deviation 3.8
Secondary

Brief Psychiatric Rating Scale (BPRS) - Total Score

The total BPRS score is calculated by adding the scores for scales #1-#18. Each scale ranges from 1=Not Present to 7=Very Severe. Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating.

Time frame: Every other week for 6 weeks

Population: Safety data available for 56 participants exposed to study treatment.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineBrief Psychiatric Rating Scale (BPRS) - Total ScoreTreatment Week 034.16 units on a scaleStandard Deviation 5.66
1: Oxytocin/Placebo-galantamineBrief Psychiatric Rating Scale (BPRS) - Total ScoreTreatment Week 234.00 units on a scaleStandard Deviation 7.46
1: Oxytocin/Placebo-galantamineBrief Psychiatric Rating Scale (BPRS) - Total ScoreTreatment Week 434.07 units on a scaleStandard Deviation 6.15
1: Oxytocin/Placebo-galantamineBrief Psychiatric Rating Scale (BPRS) - Total ScoreTreatment Week 634.33 units on a scaleStandard Deviation 5.09
2: Galantamine/Placebo-oxytocinBrief Psychiatric Rating Scale (BPRS) - Total ScoreTreatment Week 627.67 units on a scaleStandard Deviation 6.42
2: Galantamine/Placebo-oxytocinBrief Psychiatric Rating Scale (BPRS) - Total ScoreTreatment Week 030.35 units on a scaleStandard Deviation 6.66
2: Galantamine/Placebo-oxytocinBrief Psychiatric Rating Scale (BPRS) - Total ScoreTreatment Week 427.83 units on a scaleStandard Deviation 6.88
2: Galantamine/Placebo-oxytocinBrief Psychiatric Rating Scale (BPRS) - Total ScoreTreatment Week 228.95 units on a scaleStandard Deviation 7.83
3: Placebo-galantamine /Placebo-oxytocinBrief Psychiatric Rating Scale (BPRS) - Total ScoreTreatment Week 632.18 units on a scaleStandard Deviation 6.21
3: Placebo-galantamine /Placebo-oxytocinBrief Psychiatric Rating Scale (BPRS) - Total ScoreTreatment Week 231.75 units on a scaleStandard Deviation 7.26
3: Placebo-galantamine /Placebo-oxytocinBrief Psychiatric Rating Scale (BPRS) - Total ScoreTreatment Week 431.72 units on a scaleStandard Deviation 7.25
3: Placebo-galantamine /Placebo-oxytocinBrief Psychiatric Rating Scale (BPRS) - Total ScoreTreatment Week 032.65 units on a scaleStandard Deviation 7.09
Secondary

Calgary Depression Scale (CDS) - Total Score

Total score calculated by adding scores for scales #1-#9. Each scale ranges from 0=Absent to 3=Severe. The minimum total CDS score is 0 and the maximum total CDS score is 27. A higher score indicates a more severe depression rating.

Time frame: Every other week for 6 weeks

Population: Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineCalgary Depression Scale (CDS) - Total ScoreTreatment Week 02.37 units on a scaleStandard Deviation 2.7
1: Oxytocin/Placebo-galantamineCalgary Depression Scale (CDS) - Total ScoreTreatment Week 22.20 units on a scaleStandard Deviation 2.54
1: Oxytocin/Placebo-galantamineCalgary Depression Scale (CDS) - Total ScoreTreatment Week 42.13 units on a scaleStandard Deviation 2.13
1: Oxytocin/Placebo-galantamineCalgary Depression Scale (CDS) - Total ScoreTreatment Week 61.67 units on a scaleStandard Deviation 2.47
2: Galantamine/Placebo-oxytocinCalgary Depression Scale (CDS) - Total ScoreTreatment Week 60.50 units on a scaleStandard Deviation 0.71
2: Galantamine/Placebo-oxytocinCalgary Depression Scale (CDS) - Total ScoreTreatment Week 00.84 units on a scaleStandard Deviation 1.07
2: Galantamine/Placebo-oxytocinCalgary Depression Scale (CDS) - Total ScoreTreatment Week 40.67 units on a scaleStandard Deviation 1.28
2: Galantamine/Placebo-oxytocinCalgary Depression Scale (CDS) - Total ScoreTreatment Week 21.05 units on a scaleStandard Deviation 1.65
3: Placebo-galantamine /Placebo-oxytocinCalgary Depression Scale (CDS) - Total ScoreTreatment Week 61.29 units on a scaleStandard Deviation 1.45
3: Placebo-galantamine /Placebo-oxytocinCalgary Depression Scale (CDS) - Total ScoreTreatment Week 21.00 units on a scaleStandard Deviation 1.29
3: Placebo-galantamine /Placebo-oxytocinCalgary Depression Scale (CDS) - Total ScoreTreatment Week 40.94 units on a scaleStandard Deviation 1.97
3: Placebo-galantamine /Placebo-oxytocinCalgary Depression Scale (CDS) - Total ScoreTreatment Week 01.59 units on a scaleStandard Deviation 1.54
Secondary

Electrocardiogram (EKG)

Mean corrected QT interval (QTc) by study week and treatment.

Time frame: Once during Evaluation and once at Treatment Week 6

Population: 50 participants who completed the trial.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineElectrocardiogram (EKG)Treatment Week 6415.7 QTcStandard Deviation 28.3
1: Oxytocin/Placebo-galantamineElectrocardiogram (EKG)Evaluation Week 0416.5 QTcStandard Deviation 23.1
1: Oxytocin/Placebo-galantamineElectrocardiogram (EKG)Change-2.9 QTcStandard Deviation 20.7
2: Galantamine/Placebo-oxytocinElectrocardiogram (EKG)Treatment Week 6408.1 QTcStandard Deviation 27.2
2: Galantamine/Placebo-oxytocinElectrocardiogram (EKG)Evaluation Week 0419.0 QTcStandard Deviation 26.6
2: Galantamine/Placebo-oxytocinElectrocardiogram (EKG)Change-10.2 QTcStandard Deviation 18.3
3: Placebo-galantamine /Placebo-oxytocinElectrocardiogram (EKG)Evaluation Week 0422.6 QTcStandard Deviation 25.5
3: Placebo-galantamine /Placebo-oxytocinElectrocardiogram (EKG)Change0.9 QTcStandard Deviation 20.3
3: Placebo-galantamine /Placebo-oxytocinElectrocardiogram (EKG)Treatment Week 6423.8 QTcStandard Deviation 26.7
Secondary

Laboratory Measures - A/G Ratio

Albumin to Globulin (A/G) ratio in the blood by treatment group and visit.

Time frame: Once during evaluation and once at the end of 6 weeks of study treatment

Population: Available participant date for Evaluation and Week 6.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineLaboratory Measures - A/G RatioTreatment Week 61.71 g/dLStandard Deviation 0.64
1: Oxytocin/Placebo-galantamineLaboratory Measures - A/G RatioEvaluation1.65 g/dLStandard Deviation 0.29
1: Oxytocin/Placebo-galantamineLaboratory Measures - A/G RatioChange0.04 g/dLStandard Deviation 0.22
2: Galantamine/Placebo-oxytocinLaboratory Measures - A/G RatioTreatment Week 61.62 g/dLStandard Deviation 0.31
2: Galantamine/Placebo-oxytocinLaboratory Measures - A/G RatioEvaluation1.58 g/dLStandard Deviation 0.27
2: Galantamine/Placebo-oxytocinLaboratory Measures - A/G RatioChange0.05 g/dLStandard Deviation 0.18
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - A/G RatioEvaluation1.57 g/dLStandard Deviation 0.26
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - A/G RatioChange0.07 g/dLStandard Deviation 0.12
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - A/G RatioTreatment Week 61.60 g/dLStandard Deviation 0.26
Secondary

Laboratory Measures - Albumin

Albumin blood levels by treatment group and visit.

Time frame: Once during evaluation and once at the end of 6 weeks of study treatment

Population: Available participant lab data for Evaluation and Week 6.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineLaboratory Measures - AlbuminTreatment Week 64.38 g/dLStandard Deviation 0.25
1: Oxytocin/Placebo-galantamineLaboratory Measures - AlbuminEvaluation4.39 g/dLStandard Deviation 0.24
1: Oxytocin/Placebo-galantamineLaboratory Measures - AlbuminChange0.04 g/dLStandard Deviation 0.23
2: Galantamine/Placebo-oxytocinLaboratory Measures - AlbuminTreatment Week 64.23 g/dLStandard Deviation 0.27
2: Galantamine/Placebo-oxytocinLaboratory Measures - AlbuminEvaluation4.27 g/dLStandard Deviation 0.31
2: Galantamine/Placebo-oxytocinLaboratory Measures - AlbuminChange-0.03 g/dLStandard Deviation 0.35
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - AlbuminEvaluation4.35 g/dLStandard Deviation 0.3
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - AlbuminChange0.03 g/dLStandard Deviation 0.2
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - AlbuminTreatment Week 64.37 g/dLStandard Deviation 0.32
Secondary

Laboratory Measures - Alkaline Phosphatase

Alkaline phosphatase blood level by treatment group and visit.

Time frame: Once during evaluation and once at the end of 6 weeks of study treatment

Population: Available participant lab data at Evaluation at Week 6.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineLaboratory Measures - Alkaline PhosphataseTreatment Week 678.73 U/LStandard Deviation 31.09
1: Oxytocin/Placebo-galantamineLaboratory Measures - Alkaline PhosphataseEvaluation83.47 U/LStandard Deviation 21.56
1: Oxytocin/Placebo-galantamineLaboratory Measures - Alkaline PhosphataseChange-4.77 U/LStandard Deviation 15.81
2: Galantamine/Placebo-oxytocinLaboratory Measures - Alkaline PhosphataseTreatment Week 682.50 U/LStandard Deviation 20.5
2: Galantamine/Placebo-oxytocinLaboratory Measures - Alkaline PhosphataseEvaluation83.42 U/LStandard Deviation 16.29
2: Galantamine/Placebo-oxytocinLaboratory Measures - Alkaline PhosphataseChange0.88 U/LStandard Deviation 10.29
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - Alkaline PhosphataseEvaluation86.40 U/LStandard Deviation 23.37
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - Alkaline PhosphataseChange1.19 U/LStandard Deviation 10.97
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - Alkaline PhosphataseTreatment Week 688.95 U/LStandard Deviation 29.67
Secondary

Laboratory Measures - ALT/SGPT

Alanine transaminase/serum glutamic-pyruvic transaminase (ALT/SGPT) blood levels by treatment group and visit.

Time frame: Once during evaluation and once at the end of 6 weeks of study treatment

Population: Available participant lab data at Evaluation and Week 6.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineLaboratory Measures - ALT/SGPTTreatment Week 620.67 U/LStandard Deviation 13.03
1: Oxytocin/Placebo-galantamineLaboratory Measures - ALT/SGPTEvaluation22.87 U/LStandard Deviation 8.68
1: Oxytocin/Placebo-galantamineLaboratory Measures - ALT/SGPTChange-2.15 U/LStandard Deviation 10.2
2: Galantamine/Placebo-oxytocinLaboratory Measures - ALT/SGPTTreatment Week 628.90 U/LStandard Deviation 22.81
2: Galantamine/Placebo-oxytocinLaboratory Measures - ALT/SGPTEvaluation31.26 U/LStandard Deviation 22.93
2: Galantamine/Placebo-oxytocinLaboratory Measures - ALT/SGPTChange-2.65 U/LStandard Deviation 6.14
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - ALT/SGPTEvaluation27.40 U/LStandard Deviation 19.78
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - ALT/SGPTChange0.31 U/LStandard Deviation 8.1
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - ALT/SGPTTreatment Week 627.74 U/LStandard Deviation 16.62
Secondary

Laboratory Measures - AST/SGOT

Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) blood levels by treatment group and visit.

Time frame: Once during evaluation and once at the end of 6 weeks of study treatment

Population: Available participant lab data at Evaluation and Week 6.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineLaboratory Measures - AST/SGOTTreatment Week 620.27 U/LStandard Deviation 8.94
1: Oxytocin/Placebo-galantamineLaboratory Measures - AST/SGOTEvaluation19.87 U/LStandard Deviation 5.46
1: Oxytocin/Placebo-galantamineLaboratory Measures - AST/SGOTChange-1.46 U/LStandard Deviation 4.2
2: Galantamine/Placebo-oxytocinLaboratory Measures - AST/SGOTTreatment Week 621.45 U/LStandard Deviation 10.16
2: Galantamine/Placebo-oxytocinLaboratory Measures - AST/SGOTEvaluation22.68 U/LStandard Deviation 9.68
2: Galantamine/Placebo-oxytocinLaboratory Measures - AST/SGOTChange-1.53 U/LStandard Deviation 8.13
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - AST/SGOTEvaluation22.50 U/LStandard Deviation 9.29
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - AST/SGOTChange1.00 U/LStandard Deviation 5.43
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - AST/SGOTTreatment Week 623.58 U/LStandard Deviation 9.26
Secondary

Laboratory Measures - Bilirubin

Bilirubin blood level by treatment group and visit.

Time frame: Once during evaluation and once at the end of 6 weeks of study treatment

Population: Available participant data for Evaluation and Week 6.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineLaboratory Measures - BilirubinTreatment Week 60.49 mg/dLStandard Deviation 0.24
1: Oxytocin/Placebo-galantamineLaboratory Measures - BilirubinEvaluation0.45 mg/dLStandard Deviation 0.29
1: Oxytocin/Placebo-galantamineLaboratory Measures - BilirubinChange0.03 mg/dLStandard Deviation 0.13
2: Galantamine/Placebo-oxytocinLaboratory Measures - BilirubinTreatment Week 60.39 mg/dLStandard Deviation 0.24
2: Galantamine/Placebo-oxytocinLaboratory Measures - BilirubinEvaluation0.35 mg/dLStandard Deviation 0.19
2: Galantamine/Placebo-oxytocinLaboratory Measures - BilirubinChange0.05 mg/dLStandard Deviation 0.23
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - BilirubinEvaluation0.40 mg/dLStandard Deviation 0.26
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - BilirubinChange0.03 mg/dLStandard Deviation 0.13
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - BilirubinTreatment Week 60.38 mg/dLStandard Deviation 0.15
Secondary

Laboratory Measures - BUN

BUN blood level by treatment group and visit.

Time frame: Once during evaluation and once at the end of 6 weeks of study treatment

Population: Available participant data for Evaluation and Week 6.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineLaboratory Measures - BUNTreatment Week 612.73 mg/dLStandard Deviation 4.85
1: Oxytocin/Placebo-galantamineLaboratory Measures - BUNEvaluation12.80 mg/dLStandard Deviation 4.92
1: Oxytocin/Placebo-galantamineLaboratory Measures - BUNChange0.15 mg/dLStandard Deviation 2.82
2: Galantamine/Placebo-oxytocinLaboratory Measures - BUNTreatment Week 611.55 mg/dLStandard Deviation 3.41
2: Galantamine/Placebo-oxytocinLaboratory Measures - BUNEvaluation10.74 mg/dLStandard Deviation 3.18
2: Galantamine/Placebo-oxytocinLaboratory Measures - BUNChange1.06 mg/dLStandard Deviation 3.07
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - BUNEvaluation11.95 mg/dLStandard Deviation 4.1
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - BUNChange-0.06 mg/dLStandard Deviation 3.38
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - BUNTreatment Week 612.00 mg/dLStandard Deviation 4.76
Secondary

Laboratory Measures - Calcium

Calcium blood levels by treatment group and visit.

Time frame: Once during evaluation and once at the end of 6 weeks of study treatment

Population: Available participant lab data at Evaluation and Week 6.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineLaboratory Measures - CalciumTreatment Week 69.57 mg/dLStandard Deviation 0.32
1: Oxytocin/Placebo-galantamineLaboratory Measures - CalciumEvaluation9.53 mg/dLStandard Deviation 0.33
1: Oxytocin/Placebo-galantamineLaboratory Measures - CalciumChange0.12 mg/dLStandard Deviation 0.33
2: Galantamine/Placebo-oxytocinLaboratory Measures - CalciumTreatment Week 69.23 mg/dLStandard Deviation 0.31
2: Galantamine/Placebo-oxytocinLaboratory Measures - CalciumEvaluation9.36 mg/dLStandard Deviation 0.31
2: Galantamine/Placebo-oxytocinLaboratory Measures - CalciumChange-0.16 mg/dLStandard Deviation 0.21
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - CalciumEvaluation9.58 mg/dLStandard Deviation 0.41
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - CalciumChange-0.03 mg/dLStandard Deviation 0.36
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - CalciumTreatment Week 69.54 mg/dLStandard Deviation 0.44
Secondary

Laboratory Measures - Chloride

Chloride blood levels by treatment group and visit.

Time frame: Once during evaluation and once at the end of 6 weeks of study treatment

Population: Available participant lab data for Evaluation and Week 6.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineLaboratory Measures - ChlorideTreatment Week 6101.53 mE/qLStandard Deviation 3.54
1: Oxytocin/Placebo-galantamineLaboratory Measures - ChlorideEvaluation100.60 mE/qLStandard Deviation 2.95
1: Oxytocin/Placebo-galantamineLaboratory Measures - ChlorideChange0.62 mE/qLStandard Deviation 1.89
2: Galantamine/Placebo-oxytocinLaboratory Measures - ChlorideTreatment Week 6102.90 mE/qLStandard Deviation 2.63
2: Galantamine/Placebo-oxytocinLaboratory Measures - ChlorideEvaluation102.79 mE/qLStandard Deviation 3.41
2: Galantamine/Placebo-oxytocinLaboratory Measures - ChlorideChange-0.06 mE/qLStandard Deviation 2.7
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - ChlorideEvaluation100.15 mE/qLStandard Deviation 4.21
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - ChlorideChange0.56 mE/qLStandard Deviation 2.8
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - ChlorideTreatment Week 6100.47 mE/qLStandard Deviation 3.78
Secondary

Laboratory Measures - Cholesterol

Total cholesterol blood levels by treatment group and visit.

Time frame: Once during evaluation and once at the end of 6 weeks of study treatment

Population: Available participant lab data for Evaluation and Week 6.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineLaboratory Measures - CholesterolChange1.50 mg/dLStandard Deviation 12.61
1: Oxytocin/Placebo-galantamineLaboratory Measures - CholesterolTreatment Week 6156.93 mg/dLStandard Deviation 22.57
1: Oxytocin/Placebo-galantamineLaboratory Measures - CholesterolEvaluation159.18 mg/dLStandard Deviation 19.18
2: Galantamine/Placebo-oxytocinLaboratory Measures - CholesterolChange-2.40 mg/dLStandard Deviation 15.87
2: Galantamine/Placebo-oxytocinLaboratory Measures - CholesterolEvaluation166.07 mg/dLStandard Deviation 35.98
2: Galantamine/Placebo-oxytocinLaboratory Measures - CholesterolTreatment Week 6162.93 mg/dLStandard Deviation 22.57
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - CholesterolTreatment Week 6177.33 mg/dLStandard Deviation 36.76
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - CholesterolEvaluation179.60 mg/dLStandard Deviation 37.43
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - CholesterolChange-11.44 mg/dLStandard Deviation 31.52
Secondary

Laboratory Measures - CO2

Carbon Dioxide (CO2) blood levels by treatment group and visit.

Time frame: Once during evaluation and once at the end of 6 weeks of study treatment

Population: Available participant lab data for Evaluation and Week 6.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineLaboratory Measures - CO2Treatment Week 623.27 mE/qLStandard Deviation 2.09
1: Oxytocin/Placebo-galantamineLaboratory Measures - CO2Evaluation23.47 mE/qLStandard Deviation 2.13
1: Oxytocin/Placebo-galantamineLaboratory Measures - CO2Change-0.31 mE/qLStandard Deviation 2.21
2: Galantamine/Placebo-oxytocinLaboratory Measures - CO2Treatment Week 622.50 mE/qLStandard Deviation 2.33
2: Galantamine/Placebo-oxytocinLaboratory Measures - CO2Evaluation22.42 mE/qLStandard Deviation 3.01
2: Galantamine/Placebo-oxytocinLaboratory Measures - CO2Change-0.06 mE/qLStandard Deviation 2.77
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - CO2Evaluation23.40 mE/qLStandard Deviation 2.52
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - CO2Change-0.20 mE/qLStandard Deviation 1.52
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - CO2Treatment Week 622.83 mE/qLStandard Deviation 2.15
Secondary

Laboratory Measures - Globulin

Globulin blood levels by treatment group and visit.

Time frame: Once during evaluation and once at the end of 6 weeks of study treatment

Population: Available participant lab data for Evaluation and Week 6.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineLaboratory Measures - GlobulinTreatment Week 62.58 g/dLStandard Deviation 0.54
1: Oxytocin/Placebo-galantamineLaboratory Measures - GlobulinEvaluation2.72 g/dLStandard Deviation 0.4
1: Oxytocin/Placebo-galantamineLaboratory Measures - GlobulinChange-0.15 g/dLStandard Deviation 0.63
2: Galantamine/Placebo-oxytocinLaboratory Measures - GlobulinTreatment Week 62.66 g/dLStandard Deviation 0.51
2: Galantamine/Placebo-oxytocinLaboratory Measures - GlobulinEvaluation2.81 g/dLStandard Deviation 0.42
2: Galantamine/Placebo-oxytocinLaboratory Measures - GlobulinChange-0.18 g/dLStandard Deviation 0.38
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - GlobulinEvaluation2.82 g/dLStandard Deviation 0.37
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - GlobulinChange-0.09 g/dLStandard Deviation 0.21
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - GlobulinTreatment Week 62.78 g/dLStandard Deviation 0.38
Secondary

Laboratory Measures - Glucose

Glucose blood levels by treatment group and visit.

Time frame: Once during evaluation and once at the end of 6 weeks of study treatment

Population: Available participant lab data for Evaluation and Week 6.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineLaboratory Measures - GlucoseTreatment Week 699.67 mg/dLStandard Deviation 19.53
1: Oxytocin/Placebo-galantamineLaboratory Measures - GlucoseEvaluation108.07 mg/dLStandard Deviation 47.12
1: Oxytocin/Placebo-galantamineLaboratory Measures - GlucoseChange-9.23 mg/dLStandard Deviation 30.91
2: Galantamine/Placebo-oxytocinLaboratory Measures - GlucoseTreatment Week 6102.13 mg/dLStandard Deviation 18.13
2: Galantamine/Placebo-oxytocinLaboratory Measures - GlucoseEvaluation98.61 mg/dLStandard Deviation 15.5
2: Galantamine/Placebo-oxytocinLaboratory Measures - GlucoseChange2.00 mg/dLStandard Deviation 20.64
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - GlucoseEvaluation103.00 mg/dLStandard Deviation 21.86
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - GlucoseChange9.77 mg/dLStandard Deviation 16.51
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - GlucoseTreatment Week 6112.31 mg/dLStandard Deviation 33.36
Secondary

Laboratory Measures - HDL

High-density lipoprotein (HDL) blood levels by treatment group and visit.

Time frame: Once during evaluation and once at the end of 6 weeks of study treatment

Population: Available participant data from Evaluation and Week 6.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineLaboratory Measures - HDLTreatment Week 644.31 mg/dLStandard Deviation 14.07
1: Oxytocin/Placebo-galantamineLaboratory Measures - HDLEvaluation44.09 mg/dLStandard Deviation 12.31
1: Oxytocin/Placebo-galantamineLaboratory Measures - HDLChange-0.70 mg/dLStandard Deviation 6.31
2: Galantamine/Placebo-oxytocinLaboratory Measures - HDLTreatment Week 643.64 mg/dLStandard Deviation 11.62
2: Galantamine/Placebo-oxytocinLaboratory Measures - HDLEvaluation45.50 mg/dLStandard Deviation 14.43
2: Galantamine/Placebo-oxytocinLaboratory Measures - HDLChange2.11 mg/dLStandard Deviation 3.69
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - HDLEvaluation41.14 mg/dLStandard Deviation 10.17
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - HDLChange-1.67 mg/dLStandard Deviation 4.5
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - HDLTreatment Week 641.42 mg/dLStandard Deviation 10.75
Secondary

Laboratory Measures - LDL

Low-density lipoprotein (LDL) blood levels by treatment group and visit.

Time frame: Once during evaluation and once at the end of 6 weeks of study treatment

Population: Available participant lab data for Evaluation and Week 6.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineLaboratory Measures - LDLEvaluation90.36 mg/dLStandard Deviation 25.02
1: Oxytocin/Placebo-galantamineLaboratory Measures - LDLChange-0.60 mg/dLStandard Deviation 11.58
1: Oxytocin/Placebo-galantamineLaboratory Measures - LDLTreatment Week 685.92 mg/dLStandard Deviation 28.72
2: Galantamine/Placebo-oxytocinLaboratory Measures - LDLEvaluation91.25 mg/dLStandard Deviation 20.42
2: Galantamine/Placebo-oxytocinLaboratory Measures - LDLTreatment Week 692.29 mg/dLStandard Deviation 19.51
2: Galantamine/Placebo-oxytocinLaboratory Measures - LDLChange-1.38 mg/dLStandard Deviation 14.92
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - LDLEvaluation105.79 mg/dLStandard Deviation 37.3
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - LDLChange-13.00 mg/dLStandard Deviation 26.79
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - LDLTreatment Week 6103.73 mg/dLStandard Deviation 33.32
Secondary

Laboratory Measures - Potassium

Potassium blood levels by treatment group and visit.

Time frame: Once during evaluation and once at the end of 6 weeks of study treatment

Population: Available participant lab data at Evaluation and Week 6.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineLaboratory Measures - PotassiumTreatment Week 64.07 mE/qLStandard Deviation 0.32
1: Oxytocin/Placebo-galantamineLaboratory Measures - PotassiumEvaluation4.20 mE/qLStandard Deviation 0.47
1: Oxytocin/Placebo-galantamineLaboratory Measures - PotassiumChange-0.12 mE/qLStandard Deviation 0.43
2: Galantamine/Placebo-oxytocinLaboratory Measures - PotassiumTreatment Week 64.01 mE/qLStandard Deviation 0.27
2: Galantamine/Placebo-oxytocinLaboratory Measures - PotassiumEvaluation4.14 mE/qLStandard Deviation 0.31
2: Galantamine/Placebo-oxytocinLaboratory Measures - PotassiumChange-0.15 mE/qLStandard Deviation 0.22
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - PotassiumEvaluation4.17 mE/qLStandard Deviation 0.28
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - PotassiumChange0.00 mE/qLStandard Deviation 0.31
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - PotassiumTreatment Week 64.16 mE/qLStandard Deviation 0.39
Secondary

Laboratory Measures - Protein

Protein blood level by treatment group and visit.

Time frame: Once during evaluation and once at the end of 6 weeks of study treatment

Population: Available participant data for Evaluation and Week 6.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineLaboratory Measures - ProteinTreatment Week 67.14 g/dLStandard Deviation 0.42
1: Oxytocin/Placebo-galantamineLaboratory Measures - ProteinEvaluation7.10 g/dLStandard Deviation 0.32
1: Oxytocin/Placebo-galantamineLaboratory Measures - ProteinChange0.07 g/dLStandard Deviation 0.3
2: Galantamine/Placebo-oxytocinLaboratory Measures - ProteinTreatment Week 66.92 g/dLStandard Deviation 0.45
2: Galantamine/Placebo-oxytocinLaboratory Measures - ProteinEvaluation7.07 g/dLStandard Deviation 0.41
2: Galantamine/Placebo-oxytocinLaboratory Measures - ProteinChange-0.13 g/dLStandard Deviation 0.34
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - ProteinEvaluation7.17 g/dLStandard Deviation 0.4
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - ProteinChange-0.04 g/dLStandard Deviation 0.37
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - ProteinTreatment Week 67.15 g/dLStandard Deviation 0.42
Secondary

Laboratory Measures - Sodium

Sodium blood levels by treatment group and visit.

Time frame: Once during evaluation and once at the end of 6 weeks of study treatment

Population: Available participant lab data at Evaluation and Week 6.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineLaboratory Measures - SodiumTreatment Week 6138.53 mE/qLStandard Deviation 3.02
1: Oxytocin/Placebo-galantamineLaboratory Measures - SodiumEvaluation138.53 mE/qLStandard Deviation 2.29
1: Oxytocin/Placebo-galantamineLaboratory Measures - SodiumChange0.15 mE/qLStandard Deviation 1.63
2: Galantamine/Placebo-oxytocinLaboratory Measures - SodiumTreatment Week 6139.15 mE/qLStandard Deviation 2.16
2: Galantamine/Placebo-oxytocinLaboratory Measures - SodiumEvaluation139.53 mE/qLStandard Deviation 2.89
2: Galantamine/Placebo-oxytocinLaboratory Measures - SodiumChange-0.53 mE/qLStandard Deviation 3.22
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - SodiumEvaluation137.30 mE/qLStandard Deviation 4.28
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - SodiumChange0.31 mE/qLStandard Deviation 2.82
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - SodiumTreatment Week 6137.47 mE/qLStandard Deviation 3.96
Secondary

Laboratory Measures - Triglycerides

Triglyceride blood levels by treatment group and visit.

Time frame: Once during evaluation and once at the end of 6 weeks of study treatment

Population: Available participant lab data for Evaluation and Week 6.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineLaboratory Measures - TriglyceridesChange14.00 mg/dLStandard Deviation 40.14
1: Oxytocin/Placebo-galantamineLaboratory Measures - TriglyceridesTreatment Week 6124.79 mg/dLStandard Deviation 69.57
1: Oxytocin/Placebo-galantamineLaboratory Measures - TriglyceridesEvaluation124.55 mg/dLStandard Deviation 60.32
2: Galantamine/Placebo-oxytocinLaboratory Measures - TriglyceridesTreatment Week 6142.29 mg/dLStandard Deviation 99.53
2: Galantamine/Placebo-oxytocinLaboratory Measures - TriglyceridesEvaluation155.20 mg/dLStandard Deviation 118.82
2: Galantamine/Placebo-oxytocinLaboratory Measures - TriglyceridesChange-39.30 mg/dLStandard Deviation 77.44
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - TriglyceridesEvaluation163.47 mg/dLStandard Deviation 102.54
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - TriglyceridesChange1.22 mg/dLStandard Deviation 49.85
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - TriglyceridesTreatment Week 6162.17 mg/dLStandard Deviation 102.74
Secondary

Laboratory Measures - VLDL

Very low density lipoprotein (VLDL) blood levels by treatment group and visit.

Time frame: Once during evaluation and once at the end of 6 weeks of study treatment

Population: Available participant lab data for Evaluation and Week 6.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineLaboratory Measures - VLDLTreatment Week 626.75 mg/dLStandard Deviation 13.93
1: Oxytocin/Placebo-galantamineLaboratory Measures - VLDLEvaluation24.73 mg/dLStandard Deviation 12.04
1: Oxytocin/Placebo-galantamineLaboratory Measures - VLDLChange2.80 mg/dLStandard Deviation 8.13
2: Galantamine/Placebo-oxytocinLaboratory Measures - VLDLTreatment Week 623.62 mg/dLStandard Deviation 9.5
2: Galantamine/Placebo-oxytocinLaboratory Measures - VLDLEvaluation22.00 mg/dLStandard Deviation 10.49
2: Galantamine/Placebo-oxytocinLaboratory Measures - VLDLChange-3.13 mg/dLStandard Deviation 6.31
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - VLDLEvaluation33.17 mg/dLStandard Deviation 22.59
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - VLDLChange-0.43 mg/dLStandard Deviation 11.19
3: Placebo-galantamine /Placebo-oxytocinLaboratory Measures - VLDLTreatment Week 628.00 mg/dLStandard Deviation 14.04
Secondary

Neurocognitive Assessment Battery (MCCB) - Attention Vigilance

MCCB Attention Vigilance domain score by week calculated from the Continuous Performance Test, Identical Pairs version. The domain score scale is 20-80, with higher scores indicating a better outcome. .

Time frame: Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).

Population: Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineNeurocognitive Assessment Battery (MCCB) - Attention VigilanceTreatment Week 639.5 units on a scaleStandard Deviation 11.3
1: Oxytocin/Placebo-galantamineNeurocognitive Assessment Battery (MCCB) - Attention VigilanceTreatment Week 036.9 units on a scaleStandard Deviation 8.8
1: Oxytocin/Placebo-galantamineNeurocognitive Assessment Battery (MCCB) - Attention VigilanceChange2.6 units on a scaleStandard Deviation 5.8
2: Galantamine/Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Attention VigilanceTreatment Week 634.5 units on a scaleStandard Deviation 13.6
2: Galantamine/Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Attention VigilanceTreatment Week 033.5 units on a scaleStandard Deviation 14.5
2: Galantamine/Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Attention VigilanceChange1.1 units on a scaleStandard Deviation 6.9
3: Placebo-galantamine /Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Attention VigilanceTreatment Week 037.2 units on a scaleStandard Deviation 10.9
3: Placebo-galantamine /Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Attention VigilanceChange-2.1 units on a scaleStandard Deviation 6.9
3: Placebo-galantamine /Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Attention VigilanceTreatment Week 635.1 units on a scaleStandard Deviation 12.7
Secondary

Neurocognitive Assessment Battery (MCCB) - Composite Score

MCCB Composite Score by Week ranging from -10-100 with a higher score indicating a better outcome.

Time frame: Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).

Population: Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineNeurocognitive Assessment Battery (MCCB) - Composite ScoreTreatment Week 628.2 units on a scaleStandard Deviation 14.1
1: Oxytocin/Placebo-galantamineNeurocognitive Assessment Battery (MCCB) - Composite ScoreTreatment Week 025.9 units on a scaleStandard Deviation 13
1: Oxytocin/Placebo-galantamineNeurocognitive Assessment Battery (MCCB) - Composite ScoreChange2.3 units on a scaleStandard Deviation 3.9
2: Galantamine/Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Composite ScoreTreatment Week 626.2 units on a scaleStandard Deviation 11.1
2: Galantamine/Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Composite ScoreTreatment Week 024.5 units on a scaleStandard Deviation 9.7
2: Galantamine/Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Composite ScoreChange1.7 units on a scaleStandard Deviation 4
3: Placebo-galantamine /Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Composite ScoreTreatment Week 028.2 units on a scaleStandard Deviation 9.6
3: Placebo-galantamine /Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Composite ScoreChange0.7 units on a scaleStandard Deviation 8
3: Placebo-galantamine /Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Composite ScoreTreatment Week 628.9 units on a scaleStandard Deviation 11.8
Secondary

Neurocognitive Assessment Battery (MCCB) - Processing Speed

MCCB Processing Speed domain score by week calculated from the Trail Making Test- Part A, Brief Assessment of Cognition in Schizophrenia- symbol coding subtest, and the Category fluency test- animal naming. The domain score scale is 20-80, with higher scores indicating a better outcome.

Time frame: Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).

Population: Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineNeurocognitive Assessment Battery (MCCB) - Processing SpeedTreatment Week 634.2 units on a scaleStandard Deviation 11.6
1: Oxytocin/Placebo-galantamineNeurocognitive Assessment Battery (MCCB) - Processing SpeedTreatment Week 033.5 units on a scaleStandard Deviation 13.1
1: Oxytocin/Placebo-galantamineNeurocognitive Assessment Battery (MCCB) - Processing SpeedChange0.7 units on a scaleStandard Deviation 4.3
2: Galantamine/Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Processing SpeedTreatment Week 635.4 units on a scaleStandard Deviation 8.6
2: Galantamine/Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Processing SpeedTreatment Week 031.9 units on a scaleStandard Deviation 11.7
2: Galantamine/Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Processing SpeedChange3.5 units on a scaleStandard Deviation 5.6
3: Placebo-galantamine /Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Processing SpeedTreatment Week 034.0 units on a scaleStandard Deviation 10.9
3: Placebo-galantamine /Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Processing SpeedChange1.6 units on a scaleStandard Deviation 7.3
3: Placebo-galantamine /Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Processing SpeedTreatment Week 635.6 units on a scaleStandard Deviation 12.7
Secondary

Neurocognitive Assessment Battery (MCCB) - Reasoning/Problem Solving

MCCB Reasoning/Problem Solving domain score by week calculated from the Neuropsychological Assessment Battery- mazes subtest. The domain score scale is 20-80, with higher scores indicating a better outcome.

Time frame: Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).

Population: Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineNeurocognitive Assessment Battery (MCCB) - Reasoning/Problem SolvingTreatment Week 640.7 units on a scaleStandard Deviation 9.4
1: Oxytocin/Placebo-galantamineNeurocognitive Assessment Battery (MCCB) - Reasoning/Problem SolvingTreatment Week 039.7 units on a scaleStandard Deviation 10.8
1: Oxytocin/Placebo-galantamineNeurocognitive Assessment Battery (MCCB) - Reasoning/Problem SolvingChange1.0 units on a scaleStandard Deviation 8.1
2: Galantamine/Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Reasoning/Problem SolvingTreatment Week 642.9 units on a scaleStandard Deviation 8.3
2: Galantamine/Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Reasoning/Problem SolvingTreatment Week 039.3 units on a scaleStandard Deviation 6.8
2: Galantamine/Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Reasoning/Problem SolvingChange3.7 units on a scaleStandard Deviation 5.1
3: Placebo-galantamine /Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Reasoning/Problem SolvingTreatment Week 041.4 units on a scaleStandard Deviation 8.4
3: Placebo-galantamine /Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Reasoning/Problem SolvingChange0.3 units on a scaleStandard Deviation 10.1
3: Placebo-galantamine /Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Reasoning/Problem SolvingTreatment Week 641.7 units on a scaleStandard Deviation 9.7
Secondary

Neurocognitive Assessment Battery (MCCB) - Social Cognition

MCCB Social Cognition domain score by week calculated from the Mayer-Salovey-Caruso Emotional Intelligence Test- managing emotions branch. The domain score scale is 20-80, with higher scores indicating a better outcome.

Time frame: Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).

Population: Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineNeurocognitive Assessment Battery (MCCB) - Social CognitionChange0.8 units on a scaleStandard Deviation 7.6
1: Oxytocin/Placebo-galantamineNeurocognitive Assessment Battery (MCCB) - Social CognitionTreatment Week 632.5 units on a scaleStandard Deviation 13
1: Oxytocin/Placebo-galantamineNeurocognitive Assessment Battery (MCCB) - Social CognitionTreatment Week 031.7 units on a scaleStandard Deviation 9.7
2: Galantamine/Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Social CognitionTreatment Week 629.6 units on a scaleStandard Deviation 10
2: Galantamine/Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Social CognitionTreatment Week 032.8 units on a scaleStandard Deviation 10.4
2: Galantamine/Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Social CognitionChange-3.2 units on a scaleStandard Deviation 4.6
3: Placebo-galantamine /Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Social CognitionTreatment Week 030.4 units on a scaleStandard Deviation 10.1
3: Placebo-galantamine /Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Social CognitionChange2.4 units on a scaleStandard Deviation 7.3
3: Placebo-galantamine /Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Social CognitionTreatment Week 632.8 units on a scaleStandard Deviation 10.9
Secondary

Neurocognitive Assessment Battery (MCCB) - Verbal Learning

MCCB Verbal Learning domain score by week calculated from the Hopkins Verbal Learning Test-Revised, immediate recall (three learning trials only). The domain score scale is 20-80, with higher scores indicating a better outcome.

Time frame: Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).

Population: Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineNeurocognitive Assessment Battery (MCCB) - Verbal LearningTreatment Week 638.7 units on a scaleStandard Deviation 9.9
1: Oxytocin/Placebo-galantamineNeurocognitive Assessment Battery (MCCB) - Verbal LearningTreatment Week 036.3 units on a scaleStandard Deviation 8.5
1: Oxytocin/Placebo-galantamineNeurocognitive Assessment Battery (MCCB) - Verbal LearningChange2.5 units on a scaleStandard Deviation 5.4
2: Galantamine/Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Verbal LearningTreatment Week 635.8 units on a scaleStandard Deviation 7.7
2: Galantamine/Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Verbal LearningTreatment Week 033.4 units on a scaleStandard Deviation 5
2: Galantamine/Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Verbal LearningChange2.4 units on a scaleStandard Deviation 5.8
3: Placebo-galantamine /Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Verbal LearningTreatment Week 036.5 units on a scaleStandard Deviation 8.2
3: Placebo-galantamine /Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Verbal LearningChange-0.1 units on a scaleStandard Deviation 7.6
3: Placebo-galantamine /Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Verbal LearningTreatment Week 636.4 units on a scaleStandard Deviation 4.4
Secondary

Neurocognitive Assessment Battery (MCCB) - Visual Learning

MCCB Visual Learning domain score by week calculated from the Brief Visuospatial Memory Test-Revised. The domain score scale is 20-80, with higher scores indicating a better outcome.

Time frame: Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).

Population: Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineNeurocognitive Assessment Battery (MCCB) - Visual LearningTreatment Week 636.2 units on a scaleStandard Deviation 16.6
1: Oxytocin/Placebo-galantamineNeurocognitive Assessment Battery (MCCB) - Visual LearningTreatment Week 033.8 units on a scaleStandard Deviation 14.3
1: Oxytocin/Placebo-galantamineNeurocognitive Assessment Battery (MCCB) - Visual LearningChange2.4 units on a scaleStandard Deviation 6.2
2: Galantamine/Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Visual LearningTreatment Week 633.7 units on a scaleStandard Deviation 10
2: Galantamine/Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Visual LearningTreatment Week 037.2 units on a scaleStandard Deviation 10.8
2: Galantamine/Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Visual LearningChange-3.4 units on a scaleStandard Deviation 8.3
3: Placebo-galantamine /Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Visual LearningTreatment Week 035.1 units on a scaleStandard Deviation 9.4
3: Placebo-galantamine /Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Visual LearningChange-0.9 units on a scaleStandard Deviation 7.2
3: Placebo-galantamine /Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Visual LearningTreatment Week 634.2 units on a scaleStandard Deviation 10.3
Secondary

Neurocognitive Assessment Battery (MCCB) - Working Memory

MCCB Working Memory domain score by week calculated from the Wechsler Memory Scale, 3rd ed., spatial span subtest. The domain score scale is 20-80, with higher scores indicating a better outcome.

Time frame: Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).

Population: Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineNeurocognitive Assessment Battery (MCCB) - Working MemoryTreatment Week 634.8 units on a scaleStandard Deviation 11.1
1: Oxytocin/Placebo-galantamineNeurocognitive Assessment Battery (MCCB) - Working MemoryTreatment Week 034.7 units on a scaleStandard Deviation 10.7
1: Oxytocin/Placebo-galantamineNeurocognitive Assessment Battery (MCCB) - Working MemoryChange0.1 units on a scaleStandard Deviation 6.5
2: Galantamine/Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Working MemoryTreatment Week 634.7 units on a scaleStandard Deviation 10.4
2: Galantamine/Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Working MemoryTreatment Week 033.7 units on a scaleStandard Deviation 9.6
2: Galantamine/Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Working MemoryChange0.9 units on a scaleStandard Deviation 7.7
3: Placebo-galantamine /Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Working MemoryTreatment Week 035.3 units on a scaleStandard Deviation 11
3: Placebo-galantamine /Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Working MemoryChange2.8 units on a scaleStandard Deviation 6.4
3: Placebo-galantamine /Placebo-oxytocinNeurocognitive Assessment Battery (MCCB) - Working MemoryTreatment Week 638.1 units on a scaleStandard Deviation 11.7
Secondary

Positive and Negative Affect Schedule (PANAS) - Negative

Participant reported responses after Brief Role Play rating how they felt during the role plays. Participants rated 12 negative affect items on a scale of 1-5, with 1 being very slightly or not at all and 5 being extremely. The minimum score for this measure is 12 and the maximum score is 60. Higher scores indicate a higher rate of negative affect during the role plays.

Time frame: Treatment Week 0 and Week 6

Population: Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantaminePositive and Negative Affect Schedule (PANAS) - NegativeTreatment Week 618.8 units on a scaleStandard Deviation 7.7
1: Oxytocin/Placebo-galantaminePositive and Negative Affect Schedule (PANAS) - NegativeTreatment Week 020.5 units on a scaleStandard Deviation 7.8
1: Oxytocin/Placebo-galantaminePositive and Negative Affect Schedule (PANAS) - NegativeChange from Week 0 at Week 6-1.7 units on a scaleStandard Deviation 5.7
2: Galantamine/Placebo-oxytocinPositive and Negative Affect Schedule (PANAS) - NegativeTreatment Week 618.0 units on a scaleStandard Deviation 5.6
2: Galantamine/Placebo-oxytocinPositive and Negative Affect Schedule (PANAS) - NegativeTreatment Week 018.2 units on a scaleStandard Deviation 7
2: Galantamine/Placebo-oxytocinPositive and Negative Affect Schedule (PANAS) - NegativeChange from Week 0 at Week 6-0.2 units on a scaleStandard Deviation 6.8
3: Placebo-galantamine /Placebo-oxytocinPositive and Negative Affect Schedule (PANAS) - NegativeTreatment Week 020.2 units on a scaleStandard Deviation 8.6
3: Placebo-galantamine /Placebo-oxytocinPositive and Negative Affect Schedule (PANAS) - NegativeChange from Week 0 at Week 6-1.3 units on a scaleStandard Deviation 5.6
3: Placebo-galantamine /Placebo-oxytocinPositive and Negative Affect Schedule (PANAS) - NegativeTreatment Week 618.9 units on a scaleStandard Deviation 8.2
Secondary

Positive and Negative Affect Schedule (PANAS) - Positive

Participant reported responses after Brief Role Play rating how they felt during the role plays. Participants rated 12 positive affect items on a scale of 1-5, with 1 being very slightly or not at all and 5 being extremely. The minimum score for this measure is 12 and the maximum score is 60. Higher scores indicate a higher rate of positive affect during the role plays.

Time frame: Treatment Week 0 and Week 6

Population: Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantaminePositive and Negative Affect Schedule (PANAS) - PositiveTreatment Week 638.5 units on a scaleStandard Deviation 12.8
1: Oxytocin/Placebo-galantaminePositive and Negative Affect Schedule (PANAS) - PositiveTreatment Week 038.1 units on a scaleStandard Deviation 8.6
1: Oxytocin/Placebo-galantaminePositive and Negative Affect Schedule (PANAS) - PositiveChange from Week 0 at Week 60.4 units on a scaleStandard Deviation 10.8
2: Galantamine/Placebo-oxytocinPositive and Negative Affect Schedule (PANAS) - PositiveTreatment Week 639.5 units on a scaleStandard Deviation 12.3
2: Galantamine/Placebo-oxytocinPositive and Negative Affect Schedule (PANAS) - PositiveTreatment Week 037.0 units on a scaleStandard Deviation 12.3
2: Galantamine/Placebo-oxytocinPositive and Negative Affect Schedule (PANAS) - PositiveChange from Week 0 at Week 62.5 units on a scaleStandard Deviation 11.4
3: Placebo-galantamine /Placebo-oxytocinPositive and Negative Affect Schedule (PANAS) - PositiveTreatment Week 042.5 units on a scaleStandard Deviation 8.9
3: Placebo-galantamine /Placebo-oxytocinPositive and Negative Affect Schedule (PANAS) - PositiveChange from Week 0 at Week 6-1.6 units on a scaleStandard Deviation 11.2
3: Placebo-galantamine /Placebo-oxytocinPositive and Negative Affect Schedule (PANAS) - PositiveTreatment Week 640.8 units on a scaleStandard Deviation 9.6
Secondary

Reactions to Partner

Participant reported responses after Brief Role Play. The Reactions to Partner item was calculated by totaling responses to 7 scales. Each scale score ranges from 1-5, which 1 being completely agree and 5 being completely disagree. The minimum score for this measure is 7 and the maximum score is 35. Higher responses indicate a more negative reaction to their role play partner.

Time frame: Treatment Week 0 and Week 6

Population: Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineReactions to PartnerTreatment Week 613.7 units on a scaleStandard Deviation 3.1
1: Oxytocin/Placebo-galantamineReactions to PartnerTreatment Week 013.7 units on a scaleStandard Deviation 4.2
1: Oxytocin/Placebo-galantamineReactions to PartnerChange from Week 0 at Week 60.0 units on a scaleStandard Deviation 3.5
2: Galantamine/Placebo-oxytocinReactions to PartnerTreatment Week 613.9 units on a scaleStandard Deviation 3.7
2: Galantamine/Placebo-oxytocinReactions to PartnerTreatment Week 014.4 units on a scaleStandard Deviation 5.6
2: Galantamine/Placebo-oxytocinReactions to PartnerChange from Week 0 at Week 6-0.4 units on a scaleStandard Deviation 4
3: Placebo-galantamine /Placebo-oxytocinReactions to PartnerTreatment Week 012.5 units on a scaleStandard Deviation 4.2
3: Placebo-galantamine /Placebo-oxytocinReactions to PartnerChange from Week 0 at Week 60.0 units on a scaleStandard Deviation 3.7
3: Placebo-galantamine /Placebo-oxytocinReactions to PartnerTreatment Week 612.5 units on a scaleStandard Deviation 3.5
Secondary

Scale for the Assessment of Negative Symptoms (SANS) - Alogia

Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.

Time frame: Every other week for 6 weeks

Population: Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - AlogiaTreatment Week 20.44 units on a scaleStandard Deviation 0.67
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - AlogiaChange from Week 0 at Week 2-0.16 units on a scaleStandard Deviation 0.42
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - AlogiaTreatment Week 60.56 units on a scaleStandard Deviation 0.69
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - AlogiaTreatment Week 00.60 units on a scaleStandard Deviation 0.61
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - AlogiaChange from Week 0 at Week 6-0.04 units on a scaleStandard Deviation 0.46
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - AlogiaChange from Week 0 at Week 4-0.04 units on a scaleStandard Deviation 0.41
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - AlogiaTreatment Week 40.56 units on a scaleStandard Deviation 0.7
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AlogiaTreatment Week 60.78 units on a scaleStandard Deviation 0.44
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AlogiaTreatment Week 00.95 units on a scaleStandard Deviation 0.65
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AlogiaTreatment Week 20.89 units on a scaleStandard Deviation 0.59
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AlogiaTreatment Week 40.85 units on a scaleStandard Deviation 0.5
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AlogiaChange from Week 0 at Week 2-0.05 units on a scaleStandard Deviation 0.36
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AlogiaChange from Week 0 at Week 4-0.03 units on a scaleStandard Deviation 0.37
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AlogiaChange from Week 0 at Week 6-0.10 units on a scaleStandard Deviation 0.31
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AlogiaChange from Week 0 at Week 2-0.10 units on a scaleStandard Deviation 0.35
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AlogiaTreatment Week 20.89 units on a scaleStandard Deviation 0.8
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AlogiaChange from Week 0 at Week 6-0.19 units on a scaleStandard Deviation 0.31
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AlogiaChange from Week 0 at Week 4-0.17 units on a scaleStandard Deviation 0.31
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AlogiaTreatment Week 60.69 units on a scaleStandard Deviation 0.57
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AlogiaTreatment Week 40.80 units on a scaleStandard Deviation 0.61
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AlogiaTreatment Week 00.99 units on a scaleStandard Deviation 0.69
Secondary

Scale for the Assessment of Negative Symptoms (SANS) - Anhedonia

Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.

Time frame: Every other week for 6 weeks

Population: Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - AnhedoniaTreatment Week 22.42 units on a scaleStandard Deviation 0.64
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - AnhedoniaChange from Week 0 at Week 20.00 units on a scaleStandard Deviation 0.37
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - AnhedoniaTreatment Week 62.33 units on a scaleStandard Deviation 0.49
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - AnhedoniaTreatment Week 02.42 units on a scaleStandard Deviation 0.59
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - AnhedoniaChange from Week 0 at Week 6-0.09 units on a scaleStandard Deviation 0.38
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - AnhedoniaChange from Week 0 at Week 4-0.15 units on a scaleStandard Deviation 0.68
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - AnhedoniaTreatment Week 42.27 units on a scaleStandard Deviation 0.78
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AnhedoniaTreatment Week 62.43 units on a scaleStandard Deviation 0.98
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AnhedoniaTreatment Week 02.60 units on a scaleStandard Deviation 0.8
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AnhedoniaTreatment Week 22.59 units on a scaleStandard Deviation 0.86
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AnhedoniaTreatment Week 42.46 units on a scaleStandard Deviation 0.99
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AnhedoniaChange from Week 0 at Week 2-0.01 units on a scaleStandard Deviation 0.4
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AnhedoniaChange from Week 0 at Week 4-0.11 units on a scaleStandard Deviation 0.013
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AnhedoniaChange from Week 0 at Week 6-0.14 units on a scaleStandard Deviation 0.38
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AnhedoniaChange from Week 0 at Week 2-0.08 units on a scaleStandard Deviation 0.51
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AnhedoniaTreatment Week 22.58 units on a scaleStandard Deviation 0.66
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AnhedoniaChange from Week 0 at Week 60.12 units on a scaleStandard Deviation 0.47
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AnhedoniaChange from Week 0 at Week 40.01 units on a scaleStandard Deviation 0.5
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AnhedoniaTreatment Week 62.66 units on a scaleStandard Deviation 0.6
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AnhedoniaTreatment Week 42.60 units on a scaleStandard Deviation 0.64
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AnhedoniaTreatment Week 02.66 units on a scaleStandard Deviation 0.69
Secondary

Scale for the Assessment of Negative Symptoms (SANS) - Avolition

Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.

Time frame: Every other week for 6 weeks

Population: Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - AvolitionTreatment Week 22.78 units on a scaleStandard Deviation 0.77
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - AvolitionChange from Week 0 at Week 2-0.15 units on a scaleStandard Deviation 0.32
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - AvolitionTreatment Week 62.88 units on a scaleStandard Deviation 0.89
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - AvolitionTreatment Week 02.94 units on a scaleStandard Deviation 0.9
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - AvolitionChange from Week 0 at Week 6-0.05 units on a scaleStandard Deviation 0.48
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - AvolitionChange from Week 0 at Week 4-0.09 units on a scaleStandard Deviation 0.31
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - AvolitionTreatment Week 42.85 units on a scaleStandard Deviation 1.04
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AvolitionTreatment Week 62.74 units on a scaleStandard Deviation 0.9
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AvolitionTreatment Week 02.91 units on a scaleStandard Deviation 0.88
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AvolitionTreatment Week 22.73 units on a scaleStandard Deviation 0.74
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AvolitionTreatment Week 42.74 units on a scaleStandard Deviation 0.084
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AvolitionChange from Week 0 at Week 2-0.18 units on a scaleStandard Deviation 0.43
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AvolitionChange from Week 0 at Week 4-0.16 units on a scaleStandard Deviation 0.5
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AvolitionChange from Week 0 at Week 6-0.16 units on a scaleStandard Deviation 0.69
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AvolitionChange from Week 0 at Week 2-0.01 units on a scaleStandard Deviation 0.57
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AvolitionTreatment Week 22.43 units on a scaleStandard Deviation 0.93
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AvolitionChange from Week 0 at Week 60.05 units on a scaleStandard Deviation 0.46
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AvolitionChange from Week 0 at Week 40.04 units on a scaleStandard Deviation 0.43
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AvolitionTreatment Week 62.41 units on a scaleStandard Deviation 0.87
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AvolitionTreatment Week 42.44 units on a scaleStandard Deviation 0.94
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - AvolitionTreatment Week 02.44 units on a scaleStandard Deviation 0.97
Secondary

Scale for the Assessment of Negative Symptoms (SANS) - Blunted Affect

Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.

Time frame: Every other week for 6 weeks

Population: Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - Blunted AffectTreatment Week 21.32 units on a scaleStandard Deviation 0.9
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - Blunted AffectChange from Week 0 at Week 2-0.35 units on a scaleStandard Deviation 0.36
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - Blunted AffectTreatment Week 61.48 units on a scaleStandard Deviation 0.96
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - Blunted AffectTreatment Week 01.67 units on a scaleStandard Deviation 0.86
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - Blunted AffectChange from Week 0 at Week 6-0.19 units on a scaleStandard Deviation 0.36
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - Blunted AffectChange from Week 0 at Week 4-0.15 units on a scaleStandard Deviation 0.44
1: Oxytocin/Placebo-galantamineScale for the Assessment of Negative Symptoms (SANS) - Blunted AffectTreatment Week 41.52 units on a scaleStandard Deviation 0.91
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - Blunted AffectTreatment Week 61.70 units on a scaleStandard Deviation 1.05
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - Blunted AffectTreatment Week 01.96 units on a scaleStandard Deviation 1.06
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - Blunted AffectTreatment Week 21.89 units on a scaleStandard Deviation 1.1
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - Blunted AffectTreatment Week 41.79 units on a scaleStandard Deviation 0.99
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - Blunted AffectChange from Week 0 at Week 2-0.07 units on a scaleStandard Deviation 0.36
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - Blunted AffectChange from Week 0 at Week 4-0.09 units on a scaleStandard Deviation 0.33
2: Galantamine/Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - Blunted AffectChange from Week 0 at Week 6-0.17 units on a scaleStandard Deviation 0.4
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - Blunted AffectChange from Week 0 at Week 2-0.16 units on a scaleStandard Deviation 0.47
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - Blunted AffectTreatment Week 22.05 units on a scaleStandard Deviation 1.12
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - Blunted AffectChange from Week 0 at Week 6-0.19 units on a scaleStandard Deviation 0.38
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - Blunted AffectChange from Week 0 at Week 4-0.19 units on a scaleStandard Deviation 0.6
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - Blunted AffectTreatment Week 61.85 units on a scaleStandard Deviation 0.94
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - Blunted AffectTreatment Week 41.94 units on a scaleStandard Deviation 0.98
3: Placebo-galantamine /Placebo-oxytocinScale for the Assessment of Negative Symptoms (SANS) - Blunted AffectTreatment Week 02.21 units on a scaleStandard Deviation 0.97
Secondary

Side Effect Checklist (SEC) - Abdominal Pain

Percentage of participants with new onset or worsening compared to baseline of Abdominal Pain rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Abdominal Pain12.5 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Abdominal Pain5.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Abdominal Pain10.0 percentage of participants
Secondary

Side Effect Checklist (SEC) - Anorexia

Percentage of participants with new onset or worsening compared to baseline of Anorexia rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Anorexia18.8 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Anorexia10.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Anorexia15.0 percentage of participants
Secondary

Side Effect Checklist (SEC) - Bruising Easily

Percentage of participants with new onset or worsening compared to baseline of Bruising Easily rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Bruising Easily0.0 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Bruising Easily10.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Bruising Easily0.0 percentage of participants
Secondary

Side Effect Checklist (SEC) - Constipation

Percentage of participants with new onset or worsening compared to baseline of Constipation rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Constipation0.0 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Constipation0.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Constipation0.0 percentage of participants
Secondary

Side Effect Checklist (SEC) - Diarrhea

Percentage of participants with new onset or worsening compared to baseline of Diarrhea rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Diarrhea18.8 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Diarrhea30.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Diarrhea5.0 percentage of participants
Secondary

Side Effect Checklist (SEC) - Dizziness

Percentage of participants with new onset or worsening compared to baseline of Dizziness rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Dizziness18.8 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Dizziness30.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Dizziness5.0 percentage of participants
Secondary

Side Effect Checklist (SEC) - Dry Eye

Percentage of participants with new onset or worsening compared to baseline of Dry Eye rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment minus 6 participants who had missing dry eye data.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Dry Eye6.7 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Dry Eye0.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Dry Eye5.9 percentage of participants
Secondary

Side Effect Checklist (SEC) - Dry Mouth

Percentage of participants with new onset or worsening compared to baseline of Dry Mouth rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Dry Mouth18.8 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Dry Mouth5.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Dry Mouth10.0 percentage of participants
Secondary

Side Effect Checklist (SEC) - Enuresis

Percentage of participants with new onset or worsening compared to baseline of Enuresis rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Enuresis25.0 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Enuresis5.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Enuresis0.0 percentage of participants
Secondary

Side Effect Checklist (SEC) - Excessive Tearing of the Eye

Percentage of participants with new onset or worsening compared to baseline of Excessive Tearing of the Eye rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment minus 6 participants who had missing excessive tearing of the eye data.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Excessive Tearing of the Eye6.7 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Excessive Tearing of the Eye5.6 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Excessive Tearing of the Eye5.9 percentage of participants
Secondary

Side Effect Checklist (SEC) - Fever

Percentage of participants with new onset or worsening compared to baseline of Fever rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Fever0.0 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Fever5.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Fever0.0 percentage of participants
Secondary

Side Effect Checklist (SEC) - Headache

Percentage of participants with new onset or worsening compared to baseline of Headache rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Headache12.5 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Headache25.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Headache15.0 percentage of participants
Secondary

Side Effect Checklist (SEC) - Hyperhydrosis

Percentage of participants with new onset or worsening compared to baseline of Hyperhydrosis rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment minus 6 participants who had missing Hyperhydrosis data.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Hyperhydrosis0.0 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Hyperhydrosis0.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Hyperhydrosis0.0 percentage of participants
Secondary

Side Effect Checklist (SEC) - Hypersalivation

Percentage of participants with new onset or worsening compared to baseline of Hypersalivation rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Hypersalivation18.8 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Hypersalivation15.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Hypersalivation25.0 percentage of participants
Secondary

Side Effect Checklist (SEC) - Insomnia

Percentage of participants with new onset or worsening compared to baseline of Insomnia rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Insomnia18.8 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Insomnia10.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Insomnia5.0 percentage of participants
Secondary

Side Effect Checklist (SEC) - Malaise

Percentage of participants with new onset or worsening compared to baseline of Malaise rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Malaise18.8 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Malaise0.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Malaise10.0 percentage of participants
Secondary

Side Effect Checklist (SEC) - Mucosal Ulceration

Percentage of participants with new onset or worsening compared to baseline of Mucosal Ulceration rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Mucosal Ulceration6.3 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Mucosal Ulceration5.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Mucosal Ulceration0.0 percentage of participants
Secondary

Side Effect Checklist (SEC) - Nasal Irritation

Percentage of participants with new onset or worsening compared to baseline of Nasal Irritation rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment minus 6 participants who had missing nasal irritation data.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Nasal Irritation33.3 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Nasal Irritation16.7 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Nasal Irritation23.5 percentage of participants
Secondary

Side Effect Checklist (SEC) - Nausea

Percentage of participants with new onset or worsening compared to baseline of Nausea rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Nausea18.8 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Nausea15.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Nausea5.0 percentage of participants
Secondary

Side Effect Checklist (SEC) - Rash

Percentage of participants with new onset or worsening compared to baseline of Rash rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Rash12.5 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Rash10.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Rash10.0 percentage of participants
Secondary

Side Effect Checklist (SEC) - Restlessness

Percentage of participants with new onset or worsening compared to baseline of Restlessness rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Restlessness18.8 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Restlessness10.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Restlessness15.0 percentage of participants
Secondary

Side Effect Checklist (SEC) - Sedation

Percentage of participants with new onset or worsening compared to baseline of Sedation rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Sedation12.5 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Sedation15.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Sedation10.0 percentage of participants
Secondary

Side Effect Checklist (SEC) - Sore Throat

Percentage of participants with new onset or worsening compared to baseline of Sore Throat rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Sore Throat6.3 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Sore Throat10.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Sore Throat5.0 percentage of participants
Secondary

Side Effect Checklist (SEC) - Stiffness

Percentage of participants with new onset or worsening compared to baseline of Stiffness rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Stiffness6.3 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Stiffness10.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Stiffness10.0 percentage of participants
Secondary

Side Effect Checklist (SEC) - Tinnitus

Percentage of participants with new onset or worsening compared to baseline of Tinnitus rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Tinnitus0.0 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Tinnitus0.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Tinnitus10.5 percentage of participants
Secondary

Side Effect Checklist (SEC) - Tremor

Percentage of participants with new onset or worsening compared to baseline of Tremor rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Tremor6.3 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Tremor15.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Tremor10.0 percentage of participants
Secondary

Side Effect Checklist (SEC) - Urticaria

Percentage of participants with new onset or worsening compared to baseline of Urticaria rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Urticaria18.8 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Urticaria15.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Urticaria15.0 percentage of participants
Secondary

Side Effect Checklist (SEC) - Uterine Contractions

Percentage of participants with new onset or worsening compared to baseline of Uterine Contractions rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Female participants

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Uterine Contractions0.0 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Uterine Contractions0.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Uterine Contractions0.0 percentage of participants
Secondary

Side Effect Checklist (SEC) - Vomiting

Percentage of participants with new onset or worsening compared to baseline of Vomiting rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Vomiting12.5 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Vomiting5.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Vomiting10.0 percentage of participants
Secondary

Side Effect Checklist (SEC) - Weight Loss

Percentage of participants with new onset or worsening compared to baseline of Weight Loss rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Weight Loss18.8 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Weight Loss5.0 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Weight Loss25.0 percentage of participants
Secondary

Side Effect Checklist (SEC) - Wheezing

Percentage of participants with new onset or worsening compared to baseline of Wheezing rating on the SEC, by Treatment Group.

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment minus 6 participants with missing wheezing data.

ArmMeasureValue (NUMBER)
1: Oxytocin/Placebo-galantamineSide Effect Checklist (SEC) - Wheezing13.3 percentage of participants
2: Galantamine/Placebo-oxytocinSide Effect Checklist (SEC) - Wheezing5.6 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSide Effect Checklist (SEC) - Wheezing11.8 percentage of participants
Secondary

Simpson-Angus Scale (SAS)

SAS total score for extrapyramidal side effects: Frequencies of greatest within-participant increase (worsening) from pre-treatment baseline, by treatment group. Total scores calculated by adding scores from scales #1-#11. Each scale ranges from 0=None/Normal to 4=Extreme/Severe. The minimum total score is 0 and the maximum score is 44. Higher scores indicate a more severe extrapyramidal side effect rating.

Time frame: Baseline, week 3, and week 6

Population: Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.

ArmMeasureGroupValue (NUMBER)
1: Oxytocin/Placebo-galantamineSimpson-Angus Scale (SAS)No worsening (0)80 percentage of participants
1: Oxytocin/Placebo-galantamineSimpson-Angus Scale (SAS)Worsening of 116.67 percentage of participants
1: Oxytocin/Placebo-galantamineSimpson-Angus Scale (SAS)Worsening of 26.67 percentage of participants
1: Oxytocin/Placebo-galantamineSimpson-Angus Scale (SAS)Worsening of 36.67 percentage of participants
1: Oxytocin/Placebo-galantamineSimpson-Angus Scale (SAS)Worsening of 40 percentage of participants
1: Oxytocin/Placebo-galantamineSimpson-Angus Scale (SAS)Worsening of 100 percentage of participants
2: Galantamine/Placebo-oxytocinSimpson-Angus Scale (SAS)Worsening of 100 percentage of participants
2: Galantamine/Placebo-oxytocinSimpson-Angus Scale (SAS)No worsening (0)63.16 percentage of participants
2: Galantamine/Placebo-oxytocinSimpson-Angus Scale (SAS)Worsening of 35.26 percentage of participants
2: Galantamine/Placebo-oxytocinSimpson-Angus Scale (SAS)Worsening of 45.26 percentage of participants
2: Galantamine/Placebo-oxytocinSimpson-Angus Scale (SAS)Worsening of 110.53 percentage of participants
2: Galantamine/Placebo-oxytocinSimpson-Angus Scale (SAS)Worsening of 215.79 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSimpson-Angus Scale (SAS)Worsening of 110.53 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSimpson-Angus Scale (SAS)Worsening of 20 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSimpson-Angus Scale (SAS)Worsening of 105.26 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSimpson-Angus Scale (SAS)Worsening of 35.26 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSimpson-Angus Scale (SAS)No worsening (0)78.95 percentage of participants
3: Placebo-galantamine /Placebo-oxytocinSimpson-Angus Scale (SAS)Worsening of 40 percentage of participants
Secondary

Vital Signs - Diastolic Blood Pressure

Mean diastolic blood pressure by treatment and follow-up week

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineVital Signs - Diastolic Blood PressureTreatment Week 178.4 mm-HgStandard Deviation 9
1: Oxytocin/Placebo-galantamineVital Signs - Diastolic Blood PressureTreatment Week 473.9 mm-HgStandard Deviation 8.2
1: Oxytocin/Placebo-galantamineVital Signs - Diastolic Blood PressureTreatment Week 375.0 mm-HgStandard Deviation 10.6
1: Oxytocin/Placebo-galantamineVital Signs - Diastolic Blood PressureTreatment Week 078.8 mm-HgStandard Deviation 8.3
1: Oxytocin/Placebo-galantamineVital Signs - Diastolic Blood PressureTreatment Week 674.4 mm-HgStandard Deviation 8.3
1: Oxytocin/Placebo-galantamineVital Signs - Diastolic Blood PressureTreatment Week 576.2 mm-HgStandard Deviation 8.8
1: Oxytocin/Placebo-galantamineVital Signs - Diastolic Blood PressureTreatment Week 276.7 mm-HgStandard Deviation 9.1
2: Galantamine/Placebo-oxytocinVital Signs - Diastolic Blood PressureTreatment Week 379.1 mm-HgStandard Deviation 6.9
2: Galantamine/Placebo-oxytocinVital Signs - Diastolic Blood PressureTreatment Week 076.6 mm-HgStandard Deviation 10.7
2: Galantamine/Placebo-oxytocinVital Signs - Diastolic Blood PressureTreatment Week 176.2 mm-HgStandard Deviation 8.9
2: Galantamine/Placebo-oxytocinVital Signs - Diastolic Blood PressureTreatment Week 277.5 mm-HgStandard Deviation 8.4
2: Galantamine/Placebo-oxytocinVital Signs - Diastolic Blood PressureTreatment Week 475.1 mm-HgStandard Deviation 7.3
2: Galantamine/Placebo-oxytocinVital Signs - Diastolic Blood PressureTreatment Week 579.2 mm-HgStandard Deviation 8.4
2: Galantamine/Placebo-oxytocinVital Signs - Diastolic Blood PressureTreatment Week 680.7 mm-HgStandard Deviation 6.9
3: Placebo-galantamine /Placebo-oxytocinVital Signs - Diastolic Blood PressureTreatment Week 473.7 mm-HgStandard Deviation 9.7
3: Placebo-galantamine /Placebo-oxytocinVital Signs - Diastolic Blood PressureTreatment Week 175.5 mm-HgStandard Deviation 10.8
3: Placebo-galantamine /Placebo-oxytocinVital Signs - Diastolic Blood PressureTreatment Week 676.0 mm-HgStandard Deviation 9.9
3: Placebo-galantamine /Placebo-oxytocinVital Signs - Diastolic Blood PressureTreatment Week 577.2 mm-HgStandard Deviation 10.9
3: Placebo-galantamine /Placebo-oxytocinVital Signs - Diastolic Blood PressureTreatment Week 378.9 mm-HgStandard Deviation 8.1
3: Placebo-galantamine /Placebo-oxytocinVital Signs - Diastolic Blood PressureTreatment Week 279.7 mm-HgStandard Deviation 10.6
3: Placebo-galantamine /Placebo-oxytocinVital Signs - Diastolic Blood PressureTreatment Week 078.3 mm-HgStandard Deviation 10.1
Secondary

Vital Signs - Pulse

Mean sitting pulse (bpm) by treatment and follow-up week

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineVital Signs - PulseTreatment Week 081.2 bpmStandard Deviation 10.4
1: Oxytocin/Placebo-galantamineVital Signs - PulseTreatment Week 479.6 bpmStandard Deviation 13.2
1: Oxytocin/Placebo-galantamineVital Signs - PulseTreatment Week 578.4 bpmStandard Deviation 13.2
1: Oxytocin/Placebo-galantamineVital Signs - PulseTreatment Week 676.1 bpmStandard Deviation 15
1: Oxytocin/Placebo-galantamineVital Signs - PulseTreatment Week 186.2 bpmStandard Deviation 18.8
1: Oxytocin/Placebo-galantamineVital Signs - PulseTreatment Week 282.7 bpmStandard Deviation 17.3
1: Oxytocin/Placebo-galantamineVital Signs - PulseTreatment Week 376.5 bpmStandard Deviation 11.5
2: Galantamine/Placebo-oxytocinVital Signs - PulseTreatment Week 685.2 bpmStandard Deviation 16.6
2: Galantamine/Placebo-oxytocinVital Signs - PulseTreatment Week 389.2 bpmStandard Deviation 15.6
2: Galantamine/Placebo-oxytocinVital Signs - PulseTreatment Week 291.3 bpmStandard Deviation 14.2
2: Galantamine/Placebo-oxytocinVital Signs - PulseTreatment Week 488.6 bpmStandard Deviation 12.9
2: Galantamine/Placebo-oxytocinVital Signs - PulseTreatment Week 086.0 bpmStandard Deviation 14.1
2: Galantamine/Placebo-oxytocinVital Signs - PulseTreatment Week 191.6 bpmStandard Deviation 14.9
2: Galantamine/Placebo-oxytocinVital Signs - PulseTreatment Week 598.6 bpmStandard Deviation 28.1
3: Placebo-galantamine /Placebo-oxytocinVital Signs - PulseTreatment Week 189.3 bpmStandard Deviation 16.7
3: Placebo-galantamine /Placebo-oxytocinVital Signs - PulseTreatment Week 684.7 bpmStandard Deviation 12.2
3: Placebo-galantamine /Placebo-oxytocinVital Signs - PulseTreatment Week 590.5 bpmStandard Deviation 16
3: Placebo-galantamine /Placebo-oxytocinVital Signs - PulseTreatment Week 085.2 bpmStandard Deviation 13.4
3: Placebo-galantamine /Placebo-oxytocinVital Signs - PulseTreatment Week 389.2 bpmStandard Deviation 13.8
3: Placebo-galantamine /Placebo-oxytocinVital Signs - PulseTreatment Week 287.3 bpmStandard Deviation 15.3
3: Placebo-galantamine /Placebo-oxytocinVital Signs - PulseTreatment Week 483.7 bpmStandard Deviation 14.2
Secondary

Vital Signs - Systolic Blood Pressure

Mean systolic blood pressure by treatment and follow-up week

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineVital Signs - Systolic Blood PressureTreatment Week 1126.1 mm-HgStandard Deviation 16.9
1: Oxytocin/Placebo-galantamineVital Signs - Systolic Blood PressureTreatment Week 4124.8 mm-HgStandard Deviation 17.3
1: Oxytocin/Placebo-galantamineVital Signs - Systolic Blood PressureTreatment Week 3129.5 mm-HgStandard Deviation 21.1
1: Oxytocin/Placebo-galantamineVital Signs - Systolic Blood PressureTreatment Week 0128.4 mm-HgStandard Deviation 16.7
1: Oxytocin/Placebo-galantamineVital Signs - Systolic Blood PressureTreatment Week 6124.0 mm-HgStandard Deviation 17.5
1: Oxytocin/Placebo-galantamineVital Signs - Systolic Blood PressureTreatment Week 5128.4 mm-HgStandard Deviation 20.5
1: Oxytocin/Placebo-galantamineVital Signs - Systolic Blood PressureTreatment Week 2121.9 mm-HgStandard Deviation 20.5
2: Galantamine/Placebo-oxytocinVital Signs - Systolic Blood PressureTreatment Week 3127.3 mm-HgStandard Deviation 19
2: Galantamine/Placebo-oxytocinVital Signs - Systolic Blood PressureTreatment Week 0123.4 mm-HgStandard Deviation 17.3
2: Galantamine/Placebo-oxytocinVital Signs - Systolic Blood PressureTreatment Week 1123.9 mm-HgStandard Deviation 15
2: Galantamine/Placebo-oxytocinVital Signs - Systolic Blood PressureTreatment Week 2123.7 mm-HgStandard Deviation 13.8
2: Galantamine/Placebo-oxytocinVital Signs - Systolic Blood PressureTreatment Week 4123.8 mm-HgStandard Deviation 19
2: Galantamine/Placebo-oxytocinVital Signs - Systolic Blood PressureTreatment Week 5126.9 mm-HgStandard Deviation 20.1
2: Galantamine/Placebo-oxytocinVital Signs - Systolic Blood PressureTreatment Week 6129.6 mm-HgStandard Deviation 16.1
3: Placebo-galantamine /Placebo-oxytocinVital Signs - Systolic Blood PressureTreatment Week 4129.9 mm-HgStandard Deviation 16.5
3: Placebo-galantamine /Placebo-oxytocinVital Signs - Systolic Blood PressureTreatment Week 1127.4 mm-HgStandard Deviation 22.1
3: Placebo-galantamine /Placebo-oxytocinVital Signs - Systolic Blood PressureTreatment Week 6134.5 mm-HgStandard Deviation 19.4
3: Placebo-galantamine /Placebo-oxytocinVital Signs - Systolic Blood PressureTreatment Week 5132.8 mm-HgStandard Deviation 19.5
3: Placebo-galantamine /Placebo-oxytocinVital Signs - Systolic Blood PressureTreatment Week 3137.7 mm-HgStandard Deviation 17
3: Placebo-galantamine /Placebo-oxytocinVital Signs - Systolic Blood PressureTreatment Week 2136.2 mm-HgStandard Deviation 25.1
3: Placebo-galantamine /Placebo-oxytocinVital Signs - Systolic Blood PressureTreatment Week 0132.3 mm-HgStandard Deviation 19.6
Secondary

Vital Signs - Weight

Mean weight (kg) by treatment and follow-up week

Time frame: Weekly for 6 weeks

Population: Safety data for 56 participants exposed to study treatment.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineVital Signs - WeightTreatment Week 197.8 kgStandard Deviation 19.1
1: Oxytocin/Placebo-galantamineVital Signs - WeightTreatment Week 4100.0 kgStandard Deviation 17.9
1: Oxytocin/Placebo-galantamineVital Signs - WeightTreatment Week 398.0 kgStandard Deviation 18.9
1: Oxytocin/Placebo-galantamineVital Signs - WeightTreatment Week 096.5 kgStandard Deviation 18.4
1: Oxytocin/Placebo-galantamineVital Signs - WeightTreatment Week 697.6 kgStandard Deviation 18
1: Oxytocin/Placebo-galantamineVital Signs - WeightTreatment Week 598.1 kgStandard Deviation 18.6
1: Oxytocin/Placebo-galantamineVital Signs - WeightTreatment Week 298.0 kgStandard Deviation 18.9
2: Galantamine/Placebo-oxytocinVital Signs - WeightTreatment Week 394.5 kgStandard Deviation 13.8
2: Galantamine/Placebo-oxytocinVital Signs - WeightTreatment Week 096.2 kgStandard Deviation 16.2
2: Galantamine/Placebo-oxytocinVital Signs - WeightTreatment Week 197.5 kgStandard Deviation 16
2: Galantamine/Placebo-oxytocinVital Signs - WeightTreatment Week 297.5 kgStandard Deviation 16.1
2: Galantamine/Placebo-oxytocinVital Signs - WeightTreatment Week 495.5 kgStandard Deviation 14.4
2: Galantamine/Placebo-oxytocinVital Signs - WeightTreatment Week 594.0 kgStandard Deviation 14.6
2: Galantamine/Placebo-oxytocinVital Signs - WeightTreatment Week 695.1 kgStandard Deviation 14.7
3: Placebo-galantamine /Placebo-oxytocinVital Signs - WeightTreatment Week 4100.3 kgStandard Deviation 17.7
3: Placebo-galantamine /Placebo-oxytocinVital Signs - WeightTreatment Week 197.9 kgStandard Deviation 18.9
3: Placebo-galantamine /Placebo-oxytocinVital Signs - WeightTreatment Week 697.9 kgStandard Deviation 16.3
3: Placebo-galantamine /Placebo-oxytocinVital Signs - WeightTreatment Week 5100.8 kgStandard Deviation 17.7
3: Placebo-galantamine /Placebo-oxytocinVital Signs - WeightTreatment Week 398.4 kgStandard Deviation 19.5
3: Placebo-galantamine /Placebo-oxytocinVital Signs - WeightTreatment Week 298.3 kgStandard Deviation 18.8
3: Placebo-galantamine /Placebo-oxytocinVital Signs - WeightTreatment Week 096.4 kgStandard Deviation 20
Secondary

Willingness to Interact

Participant reported responses after Brief Role Play. The Willingness to Interact item calculated by totaling scores from items 1-6. Each score ranges from 1-5, with 1 being definitely willing and 5 being definitely unwilling. The minimum score for this measure is 6 and the maximum score is 30. Lower scores indicate more willingness to interact with their role play partner again in the future.

Time frame: Treatment Week 0 and Week 6

Population: Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.

ArmMeasureGroupValue (MEAN)Dispersion
1: Oxytocin/Placebo-galantamineWillingness to InteractTreatment Week 624.47 units on a scaleStandard Deviation 3.31
1: Oxytocin/Placebo-galantamineWillingness to InteractTreatment Week 023.67 units on a scaleStandard Deviation 4.13
1: Oxytocin/Placebo-galantamineWillingness to InteractChange from Week 0 at Week 60.80 units on a scaleStandard Deviation 3.82
2: Galantamine/Placebo-oxytocinWillingness to InteractTreatment Week 624.24 units on a scaleStandard Deviation 4.34
2: Galantamine/Placebo-oxytocinWillingness to InteractTreatment Week 023.18 units on a scaleStandard Deviation 4.22
2: Galantamine/Placebo-oxytocinWillingness to InteractChange from Week 0 at Week 61.06 units on a scaleStandard Deviation 3.6
3: Placebo-galantamine /Placebo-oxytocinWillingness to InteractTreatment Week 024.41 units on a scaleStandard Deviation 4.33
3: Placebo-galantamine /Placebo-oxytocinWillingness to InteractChange from Week 0 at Week 60.59 units on a scaleStandard Deviation 4.02
3: Placebo-galantamine /Placebo-oxytocinWillingness to InteractTreatment Week 625.00 units on a scaleStandard Deviation 4.29

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026