ASD, Autism, Autism Spectrum Disorder
Conditions
Keywords
Autism Spectrum Disorder (ASD), Autism
Brief summary
The purpose of this clinical trial is to investigate the effectiveness of vasopressin nasal spray for treating symptoms associated with autism. Vasopressin is a hormone that is produced naturally within the body and has been implicated in regulating social behaviors. It has been proposed that administration of the hormone may also help improve social functioning in individuals with autism.
Interventions
DRUGVasopressin (USP) Injectable Solution [Vasostrict]
Nasal Spray
DRUGPlacebo
Placebo Nasal Spray
Sponsors
Stanford University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Medically healthy outpatients between 6 and 17 years of age; * Diagnostic and Statistical Manual 5th edition (DSM-5) criteria for Autism Spectrum Disorder (ASD) on the basis of clinical evaluation, confirmed with the Autism Diagnostic Interview Revised (ADI-R) and Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) or Childhood Autism Rating Scale, Second Edition (CARS-2); * males and females; * intelligence quotient (IQ) of 40 and above; * rating of 4 or higher on the Social Communication domain of the Clinical Global Impressions Severity (CGI-S); * Social Responsiveness Scale-2 Total Score of 70 and above; * care provider who can reliably bring participant to clinic visits, provide trustworthy ratings, and interacts with participant on a regular basis; * stable concomitant psychotropic medications or medications potentially affecting vasopressin for at least 4 weeks (with the exception of fluoxetine, 6 weeks); * no planned changes in psychosocial and biomedical interventions during the trial; * willingness to provide blood samples and ability to participate in key study procedures (i.e., diagnostic assessments and laboratory safety measurements).
Exclusion criteria
* DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder; * regular nasal obstruction or nosebleeds; * unstable medical conditions such as migraine, asthma attacks, or seizures, and significant physical illness (e.g. serious liver disease, renal dysfunction, or cardiac pathology); * clinically significant abnormal electrocardiogram reading; * history of hypersensitivity to vasopressin, its analogs, or compounding preservatives (e.g., chlorobutanol); * evidence of a genetic mutation known to cause ASD or intellectual disability (e.g., Fragile X Syndrome); or metabolic, or infectious etiology for ASD on the basis of medical history, neurologic history, and available tests for inborn errors of metabolism and chromosomal analysis; * significant hearing or vision impairments; * habitually drinks large volumes of water; * pregnant or sexually active females not using a reliable method of contraception; * current use of any medications known to interact with vasopressin including: 1) carbamazepine (i.e., Tegretol); chlorpropamide; clofibrate; urea; fludrocortisone; tricyclic antidepressants (all of which may potentiate the antidiuretic effect of vasopressin when used concurrently); 2) demeclocycline; norepinephrine; lithium; heparin; alcohol (all of which may decrease the antidiuretic effect of vasopressin when used concurrently); 3) ganglionic blocking agents including benzohexonium, chlorisondamine, pentamine (all of which may produce a marked increase in sensitivity to the pressor effects of vasopressin); * previous participation in a vasopressin clinical trial or current use of vasopressin; * current use of desmopressin (DDAVP) or oxytocin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | baseline, 4-week, 8-week | Social Responsiveness Scale, 2nd Edition (SRS) scores measure social abilities with lower scores meaning better social abilities. The SRS-2 is reported as a total score (T-Score Range: 37 to above 90), and the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5-compatible Social Communication and Interaction (SCI) score (T-Score Range: 36 to above 90) and Restricted Interests and Repetitive Behavior (RRB) score (T-Score range: 41 to above 90). A T-score of 50 indicates the population mean with a standard deviation of 10. Higher scores correspond to greater symptom levels (≤ 59: within normal limits; 60-65: mild range; 66-75: moderate range; ≥ 76: severe range). Change is reported as 4-week minus the baseline score, and 8-week minus the 4-week score. For this outcome, the baseline score is the average of the screening visit and baseline visit (average approximately 2 to 3 weeks after the screening visit). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. | baseline; 4-week; 8-week | Clinician assessment of CGI severity (CGI-S) and CGI improvement (CGI-I) scores. * Higher scores on the CGI-S mean greater social and communication deficits (range: 1 to 7). * Lower scores on the CGI-I correspond to greater improvement in the areas assessed in the CGI-S, and higher scores correspond to worsening (range: 1 to 7). There is no baseline score for the CGI-I, it represents the clinician's subjective assessment of change. |
| Change From Baseline on Reading the Mind in the Eyes Test (RMET) During Treatment. | baseline; 4-week; 8-week | Score range: 0 to 28; higher scores mean better ability to read emotions and lower scores mean worse ability to read emotions. |
| Change From Baseline on the Facial Emotion Recognition Test During Treatment. | baseline; 4-week; 8-week | Score range: 0 to 42; higher scores mean better facial emotion recognition abilities. Lower scores mean worse facial emotion recognition abilities. |
| Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment. | baseline; 4-week; 8-week | Score range: 0 to 129; higher scores on the RBS-R mean higher levels of repetitive and restricted behaviors. |
| Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. | baseline; 4-week; 8-week | Scale measuring severity of anxiety symptoms. Score range: 0 to 114; higher scores mean higher levels of anxiety, lower scores mean lower levels of anxiety. |
| Change From Baseline on Electrocardiogram (EKG) P Duration During Treatment. | baseline to 4-week, 8-week, and 12-week | — |
| Change From Baseline on Electrocardiogram (EKG) PR Interval During Treatment. | baseline to 4-week, 8-week, and 12-week | — |
| Change From Baseline on Electrocardiogram (EKG) QRS Interval During Treatment. | baseline to 4-week, 8-week, and 12-week | — |
| Change From Baseline on Electrocardiogram (EKG) QT Interval During Treatment. | baseline to 4-week, 8-week, and 12-week | — |
| Change From Baseline on Blood Clinical Labs (Sodium) During Treatment. | baseline to 4-week, 8-week, and 12-week | — |
| Change From Baseline on Blood Clinical Labs (Potassium) During Treatment. | baseline to 4-week, 8-week, and 12-week | — |
| Change From Baseline on Blood Clinical Labs (Chloride) During Treatment. | baseline to 4-week, 8-week, and 12-week | Change from baseline on blood clinical labs (Chloride) during treatment. |
| Change From Baseline on Blood Clinical Labs (CO2) During Treatment. | baseline to 4-week, 8-week, and 12-week | — |
| Change From Baseline on Blood Clinical Labs (Anion Gap) During Treatment. | baseline to 4-week, 8-week, and 12-week | — |
| Change From Baseline on Blood Clinical Labs (Glucose) During Treatment. | baseline to 4-week, 8-week, and 12-week | — |
| Change From Baseline on Blood Clinical Labs (Creatinine) During Treatment. | baseline to 4-week, 8-week, and 12-week | — |
| Change From Baseline on Blood Clinical Labs (Urea Nitrogen) During Treatment. | baseline to 4-week, 8-week, and 12-week | — |
| Change From Baseline on Blood Clinical Labs (Calcium) During Treatment. | baseline to 4-week, 8-week, and 12-week | — |
| Change From Baseline on Blood Clinical Labs (Osmolality) During Treatment. | baseline to 4-week, 8-week, and 12-week | — |
| Change From Baseline on Urine Clinical Labs (Osmolality) During Treatment. | baseline to 4-week, 8-week, and 12-week | — |
| Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. | Up to 12 weeks | — |
| Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. | Up to 12 weeks | — |
| Change From Baseline on Vital Signs (Pulse) During Treatment. | Up to 12 weeks | — |
| Change From Baseline on Height During Treatment. | baseline to 4-week, 8-week, and 12-week | — |
| Change From Baseline on Weight During Treatment. | baseline to 4-week, 8-week, and 12-week | — |
| Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Up to 12 weeks | The DOTES evaluates a subset of symptoms related to various medical conditions. The clinician assesses intensity (0=Not assessed, 1=Not present, 2=Mild, 3=Moderate, 4=Severe), relatedness (0=None, 1=Remote, 2=Possible, 3=Probable, 4=Defined), and action taken (0=None, 1=Increased , 2=Contractive Rx, 3=Change Dose, 4=Change Dose Plus Contractive Rx, 5=Suspend Rx, 6=Discontinue Rx). Side effects are included that have increased in severity, become more likely to be related, or require action. Change from baseline is reported as the number of participants with change in these side effects during treatment. |
| Number of Participants Reporting Aggression Using the Overt Aggression Scale (OAS) During Treatment. | baseline, 4-weeks, 8-weeks | The scale evaluates the child participant's aggression. The number of children who exhibited aggression as reported by the parent is reported. |
| Adverse Event Severity | Up to 12 weeks | Adverse events collated according to intensity for each pre-allocated treatment group. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAntonio Y. Hardan, M.D.
Stanford University
PRINCIPAL_INVESTIGATORKaren J. Parker, Ph.D.
Stanford University
Participant flow
Recruitment details
Participants were randomized to one of three groups for two 4-week treatment periods. Participants in the Placebo-Placebo group were given the opportunity to enroll in a 4-week open-label extension period.
Pre-assignment details
323 participants were screened. 157 participants signed informed consent, and 108 were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Vasopressin-Vasopressin 8 weeks of vasopressin nasal spray (16 international units twice daily) | 23 |
| Placebo-Vasopressin 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily) | 44 |
| Placebo-Placebo 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily) | 39 |
| Total | 106 |
Baseline characteristics
| Characteristic | Vasopressin-Vasopressin | Placebo-Vasopressin | Placebo-Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 10.35 years STANDARD_DEVIATION 3.24 | 10.41 years STANDARD_DEVIATION 3.23 | 10.72 years STANDARD_DEVIATION 3.5 | 10.51 years STANDARD_DEVIATION 3.31 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 8 Participants | 9 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 31 Participants | 27 Participants | 75 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 3 Participants | 10 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 11 Participants | 15 Participants | 30 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Multiracial | 3 Participants | 6 Participants | 3 Participants | 12 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 5 Participants | 4 Participants | 11 Participants |
| Race/Ethnicity, Customized Unknown | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 12 Participants | 19 Participants | 16 Participants | 47 Participants |
| Region of Enrollment United States | 23 Participants | 44 Participants | 39 Participants | 106 Participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 5 Participants | 14 Participants |
| Sex: Female, Male Male | 20 Participants | 38 Participants | 34 Participants | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 42 | 0 / 39 | 0 / 21 | 0 / 38 | 0 / 39 | 0 / 32 |
| other Total, other adverse events | 12 / 22 | 31 / 42 | 29 / 39 | 15 / 21 | 24 / 38 | 26 / 39 | 20 / 32 |
| serious Total, serious adverse events | 0 / 22 | 0 / 42 | 0 / 39 | 0 / 21 | 0 / 38 | 0 / 39 | 0 / 32 |
Outcome results
Primary
Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment.
Social Responsiveness Scale, 2nd Edition (SRS) scores measure social abilities with lower scores meaning better social abilities. The SRS-2 is reported as a total score (T-Score Range: 37 to above 90), and the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5-compatible Social Communication and Interaction (SCI) score (T-Score Range: 36 to above 90) and Restricted Interests and Repetitive Behavior (RRB) score (T-Score range: 41 to above 90). A T-score of 50 indicates the population mean with a standard deviation of 10. Higher scores correspond to greater symptom levels (≤ 59: within normal limits; 60-65: mild range; 66-75: moderate range; ≥ 76: severe range). Change is reported as 4-week minus the baseline score, and 8-week minus the 4-week score. For this outcome, the baseline score is the average of the screening visit and baseline visit (average approximately 2 to 3 weeks after the screening visit).
Time frame: baseline, 4-week, 8-week
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | Total score - 4-week | 75.0000 T-score | Standard Error 2.1052 |
| Vasopressin-Vasopressin | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | Total score - change from week 4 at week 8 | -3.4420 T-score | Standard Error 1.7758 |
| Vasopressin-Vasopressin | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | RRB score - baseline | 78.0000 T-score | Standard Error 2.3077 |
| Vasopressin-Vasopressin | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | RRB score - change from week 4 at week 8 | -5.4995 T-score | Standard Error 1.977 |
| Vasopressin-Vasopressin | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | Total score - change from baseline at 4-week | -5.6779 T-score | Standard Error 1.683 |
| Vasopressin-Vasopressin | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | RRB score - change from baseline at 4-week | -5.4830 T-score | Standard Error 1.858 |
| Vasopressin-Vasopressin | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | Total score - baseline | 81.3690 T-score | Standard Error 2.1052 |
| Vasopressin-Vasopressin | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | RRB score - 4-week | 71.8095 T-score | Standard Error 2.3077 |
| Vasopressin-Vasopressin | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | SCI score - change from baseline at 4-week | -5.6451 T-score | Standard Error 1.6475 |
| Vasopressin-Vasopressin | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | SCI score - 4-week | 74.9405 T-score | Standard Error 2.0892 |
| Vasopressin-Vasopressin | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | SCI score - change from week 4 at week 8 | -2.8205 T-score | Standard Error 1.7326 |
| Vasopressin-Vasopressin | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | SCI score - baseline | 81.2500 T-score | Standard Error 2.0892 |
| Placebo-Vasopressin | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | SCI score - change from baseline at 4-week | -4.6366 T-score | Standard Error 1.2024 |
| Placebo-Vasopressin | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | Total score - 4-week | 74.7821 T-score | Standard Error 1.5448 |
| Placebo-Vasopressin | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | RRB score - 4-week | 73.0641 T-score | Standard Error 1.6934 |
| Placebo-Vasopressin | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | RRB score - change from week 4 at week 8 | -5.4625 T-score | Standard Error 1.4287 |
| Placebo-Vasopressin | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | SCI score - 4-week | 74.3718 T-score | Standard Error 1.533 |
| Placebo-Vasopressin | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | SCI score - change from week 4 at week 8 | -5.1550 T-score | Standard Error 1.2689 |
| Placebo-Vasopressin | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | RRB score - baseline | 77.0128 T-score | Standard Error 1.6934 |
| Placebo-Vasopressin | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | RRB score - change from baseline at 4-week | -3.5584 T-score | Standard Error 1.3617 |
| Placebo-Vasopressin | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | Total score - baseline | 79.6795 T-score | Standard Error 1.5448 |
| Placebo-Vasopressin | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | Total score - change from baseline at 4-week | -4.5448 T-score | Standard Error 1.2298 |
| Placebo-Vasopressin | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | Total score - change from week 4 at week 8 | -5.3854 T-score | Standard Error 1.2964 |
| Placebo-Vasopressin | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | SCI score - baseline | 79.3333 T-score | Standard Error 1.533 |
| Placebo-Placebo | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | RRB score - baseline | 80.4408 T-score | Standard Error 1.7155 |
| Placebo-Placebo | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | SCI score - baseline | 81.5987 T-score | Standard Error 1.5531 |
| Placebo-Placebo | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | Total score - change from baseline at 4-week | -6.4832 T-score | Standard Error 1.2695 |
| Placebo-Placebo | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | Total score - 4-week | 74.8816 T-score | Standard Error 1.565 |
| Placebo-Placebo | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | SCI score - change from week 4 at week 8 | -0.9782 T-score | Standard Error 1.2962 |
| Placebo-Placebo | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | SCI score - change from baseline at 4-week | -6.3462 T-score | Standard Error 1.2385 |
| Placebo-Placebo | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | Total score - change from week 4 at week 8 | -1.0443 T-score | Standard Error 1.3267 |
| Placebo-Placebo | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | SCI score - 4-week | 74.5263 T-score | Standard Error 1.5531 |
| Placebo-Placebo | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | RRB score - change from week 4 at week 8 | -0.9253 T-score | Standard Error 1.4705 |
| Placebo-Placebo | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | RRB score - change from baseline at 4-week | -6.2517 T-score | Standard Error 1.4083 |
| Placebo-Placebo | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | RRB score - 4-week | 72.6974 T-score | Standard Error 1.7155 |
| Placebo-Placebo | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | Total score - baseline | 82.2281 T-score | Standard Error 1.565 |
Secondary
Adverse Event Severity
Adverse events collated according to intensity for each pre-allocated treatment group.
Time frame: Up to 12 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vasopressin-Vasopressin | Adverse Event Severity | Moderate | 3 Participants |
| Vasopressin-Vasopressin | Adverse Event Severity | Death | 0 Participants |
| Vasopressin-Vasopressin | Adverse Event Severity | Mild | 12 Participants |
| Vasopressin-Vasopressin | Adverse Event Severity | Severe | 0 Participants |
| Vasopressin-Vasopressin | Adverse Event Severity | Life-threatening | 0 Participants |
| Placebo-Vasopressin | Adverse Event Severity | Life-threatening | 0 Participants |
| Placebo-Vasopressin | Adverse Event Severity | Death | 0 Participants |
| Placebo-Vasopressin | Adverse Event Severity | Mild | 28 Participants |
| Placebo-Vasopressin | Adverse Event Severity | Moderate | 15 Participants |
| Placebo-Vasopressin | Adverse Event Severity | Severe | 1 Participants |
| Placebo-Placebo | Adverse Event Severity | Death | 0 Participants |
| Placebo-Placebo | Adverse Event Severity | Severe | 0 Participants |
| Placebo-Placebo | Adverse Event Severity | Moderate | 18 Participants |
| Placebo-Placebo | Adverse Event Severity | Life-threatening | 0 Participants |
| Placebo-Placebo | Adverse Event Severity | Mild | 23 Participants |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Adverse Event Severity | Mild | 13 Participants |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Adverse Event Severity | Moderate | 5 Participants |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Adverse Event Severity | Death | 0 Participants |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Adverse Event Severity | Life-threatening | 0 Participants |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Adverse Event Severity | Severe | 1 Participants |
| Placebo-Vasopressin Group - Treatment Period 2 | Adverse Event Severity | Death | 0 Participants |
| Placebo-Vasopressin Group - Treatment Period 2 | Adverse Event Severity | Severe | 0 Participants |
| Placebo-Vasopressin Group - Treatment Period 2 | Adverse Event Severity | Life-threatening | 0 Participants |
| Placebo-Vasopressin Group - Treatment Period 2 | Adverse Event Severity | Moderate | 13 Participants |
| Placebo-Vasopressin Group - Treatment Period 2 | Adverse Event Severity | Mild | 20 Participants |
| Placebo-Placebo Group - Treatment Period 2 | Adverse Event Severity | Moderate | 13 Participants |
| Placebo-Placebo Group - Treatment Period 2 | Adverse Event Severity | Mild | 23 Participants |
| Placebo-Placebo Group - Treatment Period 2 | Adverse Event Severity | Severe | 2 Participants |
| Placebo-Placebo Group - Treatment Period 2 | Adverse Event Severity | Death | 0 Participants |
| Placebo-Placebo Group - Treatment Period 2 | Adverse Event Severity | Life-threatening | 0 Participants |
| Open-label Vasopressin | Adverse Event Severity | Severe | 1 Participants |
| Open-label Vasopressin | Adverse Event Severity | Mild | 16 Participants |
| Open-label Vasopressin | Adverse Event Severity | Life-threatening | 0 Participants |
| Open-label Vasopressin | Adverse Event Severity | Death | 0 Participants |
| Open-label Vasopressin | Adverse Event Severity | Moderate | 9 Participants |
Secondary
Baseline Vasopressin Concentration Predicting Primary and Secondary Behavioral Outcome Measures.
Time frame: 4-week; 8-week
Secondary
Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment.
Clinician assessment of CGI severity (CGI-S) and CGI improvement (CGI-I) scores. * Higher scores on the CGI-S mean greater social and communication deficits (range: 1 to 7). * Lower scores on the CGI-I correspond to greater improvement in the areas assessed in the CGI-S, and higher scores correspond to worsening (range: 1 to 7). There is no baseline score for the CGI-I, it represents the clinician's subjective assessment of change.
Time frame: baseline; 4-week; 8-week
Population: Participants with data at the respective time point
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. | CGI-I: 4-week (end of treatment period 1) | 3.8636 score on a scale | Standard Error 0.1132 |
| Vasopressin-Vasopressin | Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. | CGI-S score - change from baseline at 4-week | 0.001903 score on a scale | Standard Error 0.03413 |
| Vasopressin-Vasopressin | Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. | CGI-I: 8-week (end of treatment period 2) | 3.5892 score on a scale | Standard Error 0.12 |
| Vasopressin-Vasopressin | Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. | CGI-S score - change from 4-week at 8-week | -0.05149 score on a scale | Standard Error 0.03633 |
| Vasopressin-Vasopressin | Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. | CGI-S score - baseline | 4.8182 score on a scale | Standard Error 0.1206 |
| Vasopressin-Vasopressin | Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. | CGI-S score - 4-week | 4.8177 score on a scale | Standard Error 0.1209 |
| Placebo-Vasopressin | Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. | CGI-S score - change from 4-week at 8-week | -0.00254 score on a scale | Standard Error 0.02589 |
| Placebo-Vasopressin | Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. | CGI-I: 4-week (end of treatment period 1) | 3.7073 score on a scale | Standard Error 0.08293 |
| Placebo-Vasopressin | Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. | CGI-S score - baseline | 4.6585 score on a scale | Standard Error 0.08834 |
| Placebo-Vasopressin | Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. | CGI-S score - change from baseline at 4-week | -0.00113 score on a scale | Standard Error 0.02499 |
| Placebo-Vasopressin | Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. | CGI-I: 8-week (end of treatment period 2) | 3.5899 score on a scale | Standard Error 0.08547 |
| Placebo-Vasopressin | Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. | CGI-S score - 4-week | 4.6576 score on a scale | Standard Error 0.08846 |
| Placebo-Placebo | Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. | CGI-I: 8-week (end of treatment period 2) | 3.7307 score on a scale | Standard Error 0.08777 |
| Placebo-Placebo | Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. | CGI-S score - 4-week | 4.7416 score on a scale | Standard Error 0.0907 |
| Placebo-Placebo | Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. | CGI-S score - change from baseline at 4-week | -0.02467 score on a scale | Standard Error 0.02562 |
| Placebo-Placebo | Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. | CGI-S score - change from 4-week at 8-week | -0.02795 score on a scale | Standard Error 0.02651 |
| Placebo-Placebo | Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. | CGI-I: 4-week (end of treatment period 1) | 3.8205 score on a scale | Standard Error 0.08503 |
| Placebo-Placebo | Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. | CGI-S score - baseline | 4.7692 score on a scale | Standard Error 0.09058 |
Secondary
Change From Baseline in Overt Aggression Scale (OAS) During Treatment.
Time frame: 2-week, 4-week; 6-week, 8-week
Secondary
Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment.
Score range: 0 to 129; higher scores on the RBS-R mean higher levels of repetitive and restricted behaviors.
Time frame: baseline; 4-week; 8-week
Population: Participants with data at the respective time point
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment. | Baseline | 24.9872 score on a scale | Standard Error 3.8628 |
| Vasopressin-Vasopressin | Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment. | Change from baseline at 4-week | -1.4292 score on a scale | Standard Error 2.4939 |
| Vasopressin-Vasopressin | Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment. | 4-week | 22.7130 score on a scale | Standard Error 4.002 |
| Vasopressin-Vasopressin | Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment. | Change from 4-week at 8-week | -4.5054 score on a scale | Standard Error 2.6993 |
| Placebo-Vasopressin | Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment. | Change from 4-week at 8-week | -2.1610 score on a scale | Standard Error 1.944 |
| Placebo-Vasopressin | Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment. | Baseline | 26.4763 score on a scale | Standard Error 2.9263 |
| Placebo-Vasopressin | Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment. | 4-week | 21.4958 score on a scale | Standard Error 2.9623 |
| Placebo-Vasopressin | Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment. | Change from baseline at 4-week | -4.6282 score on a scale | Standard Error 1.8785 |
| Placebo-Placebo | Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment. | Change from 4-week at 8-week | -0.08268 score on a scale | Standard Error 1.9332 |
| Placebo-Placebo | Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment. | Change from baseline at 4-week | -5.4530 score on a scale | Standard Error 1.8509 |
| Placebo-Placebo | Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment. | 4-week | 27.9896 score on a scale | Standard Error 2.9411 |
| Placebo-Placebo | Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment. | Baseline | 32.6154 score on a scale | Standard Error 2.872 |
Secondary
Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment.
Scale measuring severity of anxiety symptoms. Score range: 0 to 114; higher scores mean higher levels of anxiety, lower scores mean lower levels of anxiety.
Time frame: baseline; 4-week; 8-week
Population: Participants with data at the respective time point
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. | Baseline | 18.9944 score on a scale | Standard Error 2.3258 |
| Vasopressin-Vasopressin | Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. | Change from 4-week at 8-week | -3.1160 score on a scale | Standard Error 1.472 |
| Vasopressin-Vasopressin | Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. | 4-week | 14.7648 score on a scale | Standard Error 2.3563 |
| Vasopressin-Vasopressin | Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. | Change from baseline at 4-week | -2.1798 score on a scale | Standard Error 1.4413 |
| Placebo-Vasopressin | Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. | Change from baseline at 4-week | -2.5005 score on a scale | Standard Error 1.0257 |
| Placebo-Vasopressin | Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. | 4-week | 14.0044 score on a scale | Standard Error 1.7201 |
| Placebo-Vasopressin | Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. | Change from 4-week at 8-week | -3.9195 score on a scale | Standard Error 1.0731 |
| Placebo-Vasopressin | Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. | Baseline | 16.0513 score on a scale | Standard Error 1.6862 |
| Placebo-Placebo | Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. | Change from 4-week at 8-week | -1.1805 score on a scale | Standard Error 1.0743 |
| Placebo-Placebo | Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. | Baseline | 17.4681 score on a scale | Standard Error 1.697 |
| Placebo-Placebo | Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. | 4-week | 13.8016 score on a scale | Standard Error 1.7202 |
| Placebo-Placebo | Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. | Change from baseline at 4-week | -2.5485 score on a scale | Standard Error 1.0439 |
Secondary
Change From Baseline on Blood Clinical Labs (Anion Gap) During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Anion Gap) During Treatment. | 4-weeks (end of treatment period 1) | 11 mmol/L | Standard Error 0.439 |
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Anion Gap) During Treatment. | Baseline | 11.3 mmol/L | Standard Error 0.524 |
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Anion Gap) During Treatment. | 8-weeks (end of treatment period 2) | 10.8 mmol/L | Standard Error 0.763 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Anion Gap) During Treatment. | 4-weeks (end of treatment period 1) | 11.1 mmol/L | Standard Error 0.384 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Anion Gap) During Treatment. | 8-weeks (end of treatment period 2) | 11.6 mmol/L | Standard Error 0.34 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Anion Gap) During Treatment. | Baseline | 11.6 mmol/L | Standard Error 0.291 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Anion Gap) During Treatment. | 4-weeks (end of treatment period 1) | 10.8 mmol/L | Standard Error 0.482 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Anion Gap) During Treatment. | Baseline | 11 mmol/L | Standard Error 0.34 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Anion Gap) During Treatment. | 8-weeks (end of treatment period 2) | 11.5 mmol/L | Standard Error 0.479 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Anion Gap) During Treatment. | 12-weeks (end of open-label extension) | 10.9 mmol/L | Standard Error 0.446 |
Secondary
Change From Baseline on Blood Clinical Labs (Calcium) During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Calcium) During Treatment. | 8-weeks (end of treatment period 2) | 9.67 mg/dL | Standard Error 0.0642 |
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Calcium) During Treatment. | 4-weeks (end of treatment period 1) | 9.5 mg/dL | Standard Error 0.0809 |
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Calcium) During Treatment. | Baseline | 9.45 mg/dL | Standard Error 0.0797 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Calcium) During Treatment. | 8-weeks (end of treatment period 2) | 9.6 mg/dL | Standard Error 0.0671 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Calcium) During Treatment. | 4-weeks (end of treatment period 1) | 9.57 mg/dL | Standard Error 0.0564 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Calcium) During Treatment. | Baseline | 9.54 mg/dL | Standard Error 0.0443 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Calcium) During Treatment. | 12-weeks (end of open-label extension) | 9.85 mg/dL | Standard Error 0.058 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Calcium) During Treatment. | Baseline | 9.55 mg/dL | Standard Error 0.0673 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Calcium) During Treatment. | 4-weeks (end of treatment period 1) | 9.62 mg/dL | Standard Error 0.0492 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Calcium) During Treatment. | 8-weeks (end of treatment period 2) | 9.67 mg/dL | Standard Error 0.0568 |
Secondary
Change From Baseline on Blood Clinical Labs (Chloride) During Treatment.
Change from baseline on blood clinical labs (Chloride) during treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Chloride) During Treatment. | 8-weeks (end of treatment period 2) | 103 mmol/L | Standard Error 0.501 |
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Chloride) During Treatment. | 4-weeks (end of treatment period 1) | 103 mmol/L | Standard Error 0.502 |
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Chloride) During Treatment. | Baseline | 103 mmol/L | Standard Error 0.375 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Chloride) During Treatment. | 8-weeks (end of treatment period 2) | 102 mmol/L | Standard Error 0.362 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Chloride) During Treatment. | 4-weeks (end of treatment period 1) | 103 mmol/L | Standard Error 0.305 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Chloride) During Treatment. | Baseline | 103 mmol/L | Standard Error 0.298 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Chloride) During Treatment. | 12-weeks (end of open-label extension) | 102 mmol/L | Standard Error 0.308 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Chloride) During Treatment. | Baseline | 102 mmol/L | Standard Error 0.291 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Chloride) During Treatment. | 4-weeks (end of treatment period 1) | 103 mmol/L | Standard Error 0.296 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Chloride) During Treatment. | 8-weeks (end of treatment period 2) | 102 mmol/L | Standard Error 0.313 |
Secondary
Change From Baseline on Blood Clinical Labs (CO2) During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (CO2) During Treatment. | 8-weeks (end of treatment period 2) | 25.8 mmol/L | Standard Error 0.505 |
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (CO2) During Treatment. | 4-weeks (end of treatment period 1) | 25.5 mmol/L | Standard Error 0.515 |
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (CO2) During Treatment. | Baseline | 25 mmol/L | Standard Error 0.574 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (CO2) During Treatment. | 8-weeks (end of treatment period 2) | 24.8 mmol/L | Standard Error 0.321 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (CO2) During Treatment. | 4-weeks (end of treatment period 1) | 25.3 mmol/L | Standard Error 0.291 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (CO2) During Treatment. | Baseline | 25.1 mmol/L | Standard Error 0.273 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (CO2) During Treatment. | 12-weeks (end of open-label extension) | 25 mmol/L | Standard Error 0.362 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (CO2) During Treatment. | Baseline | 25.2 mmol/L | Standard Error 0.279 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (CO2) During Treatment. | 4-weeks (end of treatment period 1) | 25.7 mmol/L | Standard Error 0.452 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (CO2) During Treatment. | 8-weeks (end of treatment period 2) | 25.3 mmol/L | Standard Error 0.374 |
Secondary
Change From Baseline on Blood Clinical Labs (Creatinine) During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Creatinine) During Treatment. | 8-weeks (end of treatment period 2) | 0.531 mg/dL | Standard Error 0.048 |
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Creatinine) During Treatment. | 4-weeks (end of treatment period 1) | 0.505 mg/dL | Standard Error 0.037 |
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Creatinine) During Treatment. | Baseline | 0.473 mg/dL | Standard Error 0.0297 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Creatinine) During Treatment. | 8-weeks (end of treatment period 2) | 0.508 mg/dL | Standard Error 0.0273 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Creatinine) During Treatment. | 4-weeks (end of treatment period 1) | 0.503 mg/dL | Standard Error 0.0256 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Creatinine) During Treatment. | Baseline | 0.502 mg/dL | Standard Error 0.0243 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Creatinine) During Treatment. | 12-weeks (end of open-label extension) | 0.5 mg/dL | Standard Error 0.0257 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Creatinine) During Treatment. | Baseline | 0.515 mg/dL | Standard Error 0.0257 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Creatinine) During Treatment. | 4-weeks (end of treatment period 1) | 0.523 mg/dL | Standard Error 0.0294 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Creatinine) During Treatment. | 8-weeks (end of treatment period 2) | 0.517 mg/dL | Standard Error 0.0258 |
Secondary
Change From Baseline on Blood Clinical Labs (Glucose) During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Glucose) During Treatment. | 8-weeks (end of treatment period 2) | 93.5 mg/dL | Standard Error 1.31 |
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Glucose) During Treatment. | 4-weeks (end of treatment period 1) | 99 mg/dL | Standard Error 2.8 |
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Glucose) During Treatment. | Baseline | 95.7 mg/dL | Standard Error 2.75 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Glucose) During Treatment. | 8-weeks (end of treatment period 2) | 94.2 mg/dL | Standard Error 2.25 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Glucose) During Treatment. | 4-weeks (end of treatment period 1) | 93.7 mg/dL | Standard Error 2.33 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Glucose) During Treatment. | Baseline | 94.4 mg/dL | Standard Error 1.85 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Glucose) During Treatment. | 12-weeks (end of open-label extension) | 97 mg/dL | Standard Error 2.84 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Glucose) During Treatment. | Baseline | 94.9 mg/dL | Standard Error 2.21 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Glucose) During Treatment. | 4-weeks (end of treatment period 1) | 94.8 mg/dL | Standard Error 2.29 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Glucose) During Treatment. | 8-weeks (end of treatment period 2) | 94.5 mg/dL | Standard Error 2.27 |
Secondary
Change From Baseline on Blood Clinical Labs (Osmolality) During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Osmolality) During Treatment. | 8-weeks (end of treatment period 2) | 291 mOsm/kg | Standard Error 1.28 |
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Osmolality) During Treatment. | 4-weeks (end of treatment period 1) | 289 mOsm/kg | Standard Error 1.19 |
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Osmolality) During Treatment. | Baseline | 289 mOsm/kg | Standard Error 1.03 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Osmolality) During Treatment. | 8-weeks (end of treatment period 2) | 288 mOsm/kg | Standard Error 0.937 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Osmolality) During Treatment. | 4-weeks (end of treatment period 1) | 289 mOsm/kg | Standard Error 0.839 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Osmolality) During Treatment. | Baseline | 289 mOsm/kg | Standard Error 0.735 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Osmolality) During Treatment. | 12-weeks (end of open-label extension) | 290 mOsm/kg | Standard Error 1.29 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Osmolality) During Treatment. | Baseline | 290 mOsm/kg | Standard Error 1.03 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Osmolality) During Treatment. | 4-weeks (end of treatment period 1) | 291 mOsm/kg | Standard Error 1.13 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Osmolality) During Treatment. | 8-weeks (end of treatment period 2) | 290 mOsm/kg | Standard Error 0.935 |
Secondary
Change From Baseline on Blood Clinical Labs (Potassium) During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Potassium) During Treatment. | 8-weeks (end of treatment period 2) | 4.16 mmol/L | Standard Deviation 0.0922 |
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Potassium) During Treatment. | 4-weeks (end of treatment period 1) | 4.07 mmol/L | Standard Deviation 0.0374 |
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Potassium) During Treatment. | Baseline | 4.07 mmol/L | Standard Deviation 0.0661 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Potassium) During Treatment. | 8-weeks (end of treatment period 2) | 4.17 mmol/L | Standard Deviation 0.0714 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Potassium) During Treatment. | 4-weeks (end of treatment period 1) | 4.13 mmol/L | Standard Deviation 0.049 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Potassium) During Treatment. | Baseline | 4.14 mmol/L | Standard Deviation 0.0497 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Potassium) During Treatment. | 12-weeks (end of open-label extension) | 4.12 mmol/L | Standard Deviation 0.0742 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Potassium) During Treatment. | Baseline | 4.21 mmol/L | Standard Deviation 0.0564 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Potassium) During Treatment. | 4-weeks (end of treatment period 1) | 4.3 mmol/L | Standard Deviation 0.0751 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Potassium) During Treatment. | 8-weeks (end of treatment period 2) | 4.24 mmol/L | Standard Deviation 0.0859 |
Secondary
Change From Baseline on Blood Clinical Labs (Sodium) During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Sodium) During Treatment. | 8-weeks (end of treatment period 2) | 140 mmol/L | Standard Deviation 0.402 |
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Sodium) During Treatment. | 4-weeks (end of treatment period 1) | 139 mmol/L | Standard Deviation 0.434 |
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Sodium) During Treatment. | Baseline | 139 mmol/L | Standard Deviation 0.457 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Sodium) During Treatment. | 8-weeks (end of treatment period 2) | 139 mmol/L | Standard Deviation 0.426 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Sodium) During Treatment. | 4-weeks (end of treatment period 1) | 139 mmol/L | Standard Deviation 0.293 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Sodium) During Treatment. | Baseline | 139 mmol/L | Standard Deviation 0.252 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Sodium) During Treatment. | 12-weeks (end of open-label extension) | 139 mmol/L | Standard Deviation 0.291 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Sodium) During Treatment. | Baseline | 139 mmol/L | Standard Deviation 0.434 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Sodium) During Treatment. | 4-weeks (end of treatment period 1) | 139 mmol/L | Standard Deviation 0.232 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Sodium) During Treatment. | 8-weeks (end of treatment period 2) | 139 mmol/L | Standard Deviation 0.34 |
Secondary
Change From Baseline on Blood Clinical Labs (Urea Nitrogen) During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Urea Nitrogen) During Treatment. | 8-weeks (end of treatment period 2) | 14.2 mg/dL | Standard Error 0.957 |
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Urea Nitrogen) During Treatment. | 4-weeks (end of treatment period 1) | 12.6 mg/dL | Standard Error 0.827 |
| Vasopressin-Vasopressin | Change From Baseline on Blood Clinical Labs (Urea Nitrogen) During Treatment. | Baseline | 12.8 mg/dL | Standard Error 0.691 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Urea Nitrogen) During Treatment. | 8-weeks (end of treatment period 2) | 12.2 mg/dL | Standard Error 0.618 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Urea Nitrogen) During Treatment. | 4-weeks (end of treatment period 1) | 13.4 mg/dL | Standard Error 0.588 |
| Placebo-Vasopressin | Change From Baseline on Blood Clinical Labs (Urea Nitrogen) During Treatment. | Baseline | 13.7 mg/dL | Standard Error 0.462 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Urea Nitrogen) During Treatment. | 12-weeks (end of open-label extension) | 13.8 mg/dL | Standard Error 0.638 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Urea Nitrogen) During Treatment. | Baseline | 13.7 mg/dL | Standard Error 0.465 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Urea Nitrogen) During Treatment. | 4-weeks (end of treatment period 1) | 13.4 mg/dL | Standard Error 0.587 |
| Placebo-Placebo | Change From Baseline on Blood Clinical Labs (Urea Nitrogen) During Treatment. | 8-weeks (end of treatment period 2) | 14 mg/dL | Standard Error 0.683 |
Secondary
Change From Baseline on Electrocardiogram (EKG) P Duration During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline on Electrocardiogram (EKG) P Duration During Treatment. | 8-weeks (end of treatment period 2) | 88.2 milliseconds | Standard Deviation 2.03 |
| Vasopressin-Vasopressin | Change From Baseline on Electrocardiogram (EKG) P Duration During Treatment. | 4-weeks (end of treatment period 1) | 83.7 milliseconds | Standard Deviation 2.11 |
| Vasopressin-Vasopressin | Change From Baseline on Electrocardiogram (EKG) P Duration During Treatment. | Baseline | 87.9 milliseconds | Standard Deviation 1.88 |
| Placebo-Vasopressin | Change From Baseline on Electrocardiogram (EKG) P Duration During Treatment. | 8-weeks (end of treatment period 2) | 85.6 milliseconds | Standard Deviation 1.5 |
| Placebo-Vasopressin | Change From Baseline on Electrocardiogram (EKG) P Duration During Treatment. | 4-weeks (end of treatment period 1) | 87.1 milliseconds | Standard Deviation 1.88 |
| Placebo-Vasopressin | Change From Baseline on Electrocardiogram (EKG) P Duration During Treatment. | Baseline | 86.5 milliseconds | Standard Deviation 1.53 |
| Placebo-Placebo | Change From Baseline on Electrocardiogram (EKG) P Duration During Treatment. | 12-weeks (end of open-label extension) | 89.6 milliseconds | Standard Deviation 1.33 |
| Placebo-Placebo | Change From Baseline on Electrocardiogram (EKG) P Duration During Treatment. | Baseline | 86.7 milliseconds | Standard Deviation 1.18 |
| Placebo-Placebo | Change From Baseline on Electrocardiogram (EKG) P Duration During Treatment. | 4-weeks (end of treatment period 1) | 87.0 milliseconds | Standard Deviation 1.44 |
| Placebo-Placebo | Change From Baseline on Electrocardiogram (EKG) P Duration During Treatment. | 8-weeks (end of treatment period 2) | 84.4 milliseconds | Standard Deviation 1.36 |
Secondary
Change From Baseline on Electrocardiogram (EKG) PR Interval During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline on Electrocardiogram (EKG) PR Interval During Treatment. | 8-weeks (end of treatment period 2) | 135 milliseconds | Standard Deviation 2.96 |
| Vasopressin-Vasopressin | Change From Baseline on Electrocardiogram (EKG) PR Interval During Treatment. | 4-weeks (end of treatment period 1) | 136 milliseconds | Standard Deviation 3.48 |
| Vasopressin-Vasopressin | Change From Baseline on Electrocardiogram (EKG) PR Interval During Treatment. | Baseline | 136 milliseconds | Standard Deviation 3.48 |
| Placebo-Vasopressin | Change From Baseline on Electrocardiogram (EKG) PR Interval During Treatment. | 8-weeks (end of treatment period 2) | 141 milliseconds | Standard Deviation 0.345 |
| Placebo-Vasopressin | Change From Baseline on Electrocardiogram (EKG) PR Interval During Treatment. | 4-weeks (end of treatment period 1) | 139 milliseconds | Standard Deviation 3.02 |
| Placebo-Vasopressin | Change From Baseline on Electrocardiogram (EKG) PR Interval During Treatment. | Baseline | 138 milliseconds | Standard Deviation 2.38 |
| Placebo-Placebo | Change From Baseline on Electrocardiogram (EKG) PR Interval During Treatment. | 12-weeks (end of open-label extension) | 142 milliseconds | Standard Deviation 2.73 |
| Placebo-Placebo | Change From Baseline on Electrocardiogram (EKG) PR Interval During Treatment. | Baseline | 137 milliseconds | Standard Deviation 2.34 |
| Placebo-Placebo | Change From Baseline on Electrocardiogram (EKG) PR Interval During Treatment. | 4-weeks (end of treatment period 1) | 140 milliseconds | Standard Deviation 2.6 |
| Placebo-Placebo | Change From Baseline on Electrocardiogram (EKG) PR Interval During Treatment. | 8-weeks (end of treatment period 2) | 139 milliseconds | Standard Deviation 2.95 |
Secondary
Change From Baseline on Electrocardiogram (EKG) QRS Interval During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline on Electrocardiogram (EKG) QRS Interval During Treatment. | 8-weeks (end of treatment period 2) | 29.3 milliseconds | Standard Deviation 0.87 |
| Vasopressin-Vasopressin | Change From Baseline on Electrocardiogram (EKG) QRS Interval During Treatment. | 4-weeks (end of treatment period 1) | 89.5 milliseconds | Standard Deviation 2.45 |
| Vasopressin-Vasopressin | Change From Baseline on Electrocardiogram (EKG) QRS Interval During Treatment. | Baseline | 87.3 milliseconds | Standard Deviation 1.76 |
| Placebo-Vasopressin | Change From Baseline on Electrocardiogram (EKG) QRS Interval During Treatment. | 8-weeks (end of treatment period 2) | 89.2 milliseconds | Standard Deviation 1.52 |
| Placebo-Vasopressin | Change From Baseline on Electrocardiogram (EKG) QRS Interval During Treatment. | 4-weeks (end of treatment period 1) | 88.6 milliseconds | Standard Deviation 41.5 |
| Placebo-Vasopressin | Change From Baseline on Electrocardiogram (EKG) QRS Interval During Treatment. | Baseline | 89.5 milliseconds | Standard Deviation 1.27 |
| Placebo-Placebo | Change From Baseline on Electrocardiogram (EKG) QRS Interval During Treatment. | 12-weeks (end of open-label extension) | 84.6 milliseconds | Standard Deviation 1.52 |
| Placebo-Placebo | Change From Baseline on Electrocardiogram (EKG) QRS Interval During Treatment. | Baseline | 86.7 milliseconds | Standard Deviation 1.44 |
| Placebo-Placebo | Change From Baseline on Electrocardiogram (EKG) QRS Interval During Treatment. | 4-weeks (end of treatment period 1) | 86.5 milliseconds | Standard Deviation 1.24 |
| Placebo-Placebo | Change From Baseline on Electrocardiogram (EKG) QRS Interval During Treatment. | 8-weeks (end of treatment period 2) | 86.2 milliseconds | Standard Deviation 1.7 |
Secondary
Change From Baseline on Electrocardiogram (EKG) QT Interval During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline on Electrocardiogram (EKG) QT Interval During Treatment. | Baseline | 399 milliseconds | Standard Deviation 6.03 |
| Vasopressin-Vasopressin | Change From Baseline on Electrocardiogram (EKG) QT Interval During Treatment. | 8-weeks (end of treatment period 2) | 355 milliseconds | Standard Deviation 5.37 |
| Vasopressin-Vasopressin | Change From Baseline on Electrocardiogram (EKG) QT Interval During Treatment. | 4-weeks (end of treatment period 1) | 352 milliseconds | Standard Deviation 6.94 |
| Placebo-Vasopressin | Change From Baseline on Electrocardiogram (EKG) QT Interval During Treatment. | Baseline | 355 milliseconds | Standard Deviation 3.61 |
| Placebo-Vasopressin | Change From Baseline on Electrocardiogram (EKG) QT Interval During Treatment. | 8-weeks (end of treatment period 2) | 359 milliseconds | Standard Deviation 4.79 |
| Placebo-Vasopressin | Change From Baseline on Electrocardiogram (EKG) QT Interval During Treatment. | 4-weeks (end of treatment period 1) | 365 milliseconds | Standard Deviation 4.24 |
| Placebo-Placebo | Change From Baseline on Electrocardiogram (EKG) QT Interval During Treatment. | 8-weeks (end of treatment period 2) | 354 milliseconds | Standard Deviation 5.23 |
| Placebo-Placebo | Change From Baseline on Electrocardiogram (EKG) QT Interval During Treatment. | 4-weeks (end of treatment period 1) | 350 milliseconds | Standard Deviation 4.27 |
| Placebo-Placebo | Change From Baseline on Electrocardiogram (EKG) QT Interval During Treatment. | 12-weeks (end of open-label extension) | 344 milliseconds | Standard Deviation 4 |
| Placebo-Placebo | Change From Baseline on Electrocardiogram (EKG) QT Interval During Treatment. | Baseline | 348 milliseconds | Standard Deviation 4.05 |
Secondary
Change From Baseline on Height During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline on Height During Treatment. | 8-weeks (end of treatment period 2) | 145 cm | Standard Error 4.43 |
| Vasopressin-Vasopressin | Change From Baseline on Height During Treatment. | 4-weeks (end of treatment period 1) | 142 cm | Standard Error 5.96 |
| Vasopressin-Vasopressin | Change From Baseline on Height During Treatment. | Baseline | 145 cm | Standard Error 3.91 |
| Placebo-Vasopressin | Change From Baseline on Height During Treatment. | 8-weeks (end of treatment period 2) | 148 cm | Standard Error 3.22 |
| Placebo-Vasopressin | Change From Baseline on Height During Treatment. | 4-weeks (end of treatment period 1) | 148 cm | Standard Error 3.21 |
| Placebo-Vasopressin | Change From Baseline on Height During Treatment. | Baseline | 146 cm | Standard Error 2.98 |
| Placebo-Placebo | Change From Baseline on Height During Treatment. | 12-weeks (end of open-label extension) | 145 cm | Standard Error 3.26 |
| Placebo-Placebo | Change From Baseline on Height During Treatment. | Baseline | 145 cm | Standard Error 2.78 |
| Placebo-Placebo | Change From Baseline on Height During Treatment. | 4-weeks (end of treatment period 1) | 146 cm | Standard Error 2.76 |
| Placebo-Placebo | Change From Baseline on Height During Treatment. | 8-weeks (end of treatment period 2) | 146 cm | Standard Error 2.68 |
Secondary
Change From Baseline on Reading the Mind in the Eyes Test (RMET) During Treatment.
Score range: 0 to 28; higher scores mean better ability to read emotions and lower scores mean worse ability to read emotions.
Time frame: baseline; 4-week; 8-week
Population: Participants with data at the respective time point
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline on Reading the Mind in the Eyes Test (RMET) During Treatment. | Baseline | 16.5556 score on a scale | Standard Error 1.8377 |
| Vasopressin-Vasopressin | Change From Baseline on Reading the Mind in the Eyes Test (RMET) During Treatment. | Change from baseline at 4-week | 1.6440 score on a scale | Standard Error 1.203 |
| Vasopressin-Vasopressin | Change From Baseline on Reading the Mind in the Eyes Test (RMET) During Treatment. | 4-week | 18.3273 score on a scale | Standard Error 1.9019 |
| Vasopressin-Vasopressin | Change From Baseline on Reading the Mind in the Eyes Test (RMET) During Treatment. | Change from 4-week at 8-week | -0.2844 score on a scale | Standard Error 1.3008 |
| Placebo-Vasopressin | Change From Baseline on Reading the Mind in the Eyes Test (RMET) During Treatment. | Change from 4-week at 8-week | 0.5628 score on a scale | Standard Error 0.851 |
| Placebo-Vasopressin | Change From Baseline on Reading the Mind in the Eyes Test (RMET) During Treatment. | Baseline | 14.7222 score on a scale | Standard Error 1.2995 |
| Placebo-Vasopressin | Change From Baseline on Reading the Mind in the Eyes Test (RMET) During Treatment. | 4-week | 14.8889 score on a scale | Standard Error 1.2995 |
| Placebo-Vasopressin | Change From Baseline on Reading the Mind in the Eyes Test (RMET) During Treatment. | Change from baseline at 4-week | -0.02870 score on a scale | Standard Error 0.8518 |
| Placebo-Placebo | Change From Baseline on Reading the Mind in the Eyes Test (RMET) During Treatment. | Change from 4-week at 8-week | -0.2156 score on a scale | Standard Error 0.8771 |
| Placebo-Placebo | Change From Baseline on Reading the Mind in the Eyes Test (RMET) During Treatment. | Change from baseline at 4-week | -0.4319 score on a scale | Standard Error 0.8267 |
| Placebo-Placebo | Change From Baseline on Reading the Mind in the Eyes Test (RMET) During Treatment. | 4-week | 15.2876 score on a scale | Standard Error 1.3064 |
| Placebo-Placebo | Change From Baseline on Reading the Mind in the Eyes Test (RMET) During Treatment. | Baseline | 15.5789 score on a scale | Standard Error 1.2648 |
Secondary
Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment.
The DOTES evaluates a subset of symptoms related to various medical conditions. The clinician assesses intensity (0=Not assessed, 1=Not present, 2=Mild, 3=Moderate, 4=Severe), relatedness (0=None, 1=Remote, 2=Possible, 3=Probable, 4=Defined), and action taken (0=None, 1=Increased , 2=Contractive Rx, 3=Change Dose, 4=Change Dose Plus Contractive Rx, 5=Suspend Rx, 6=Discontinue Rx). Side effects are included that have increased in severity, become more likely to be related, or require action. Change from baseline is reported as the number of participants with change in these side effects during treatment.
Time frame: Up to 12 weeks
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Rash | 0 Participants |
| Vasopressin-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Aggression | 1 Participants |
| Vasopressin-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Decreased Appetite | 0 Participants |
| Vasopressin-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Increased Appetite | 0 Participants |
| Vasopressin-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Vomiting or Nausea | 0 Participants |
| Vasopressin-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Depressed Mood | 1 Participants |
| Vasopressin-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Initial Insomnia | 0 Participants |
| Vasopressin-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Hyperactivity | 0 Participants |
| Vasopressin-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Constipation | 2 Participants |
| Vasopressin-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Saliva Hypersecretion | 0 Participants |
| Vasopressin-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Pruritus | 0 Participants |
| Vasopressin-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Agitation | 2 Participants |
| Vasopressin-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Dry Mouth | 0 Participants |
| Vasopressin-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Headache | 2 Participants |
| Vasopressin-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Dizziness | 0 Participants |
| Vasopressin-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Unspecified Insomnia | 0 Participants |
| Vasopressin-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Nasal Congestion | 2 Participants |
| Vasopressin-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Diarrhea | 0 Participants |
| Vasopressin-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Middle Insomnia | 0 Participants |
| Placebo-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Hyperactivity | 4 Participants |
| Placebo-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Initial Insomnia | 0 Participants |
| Placebo-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Constipation | 0 Participants |
| Placebo-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Headache | 4 Participants |
| Placebo-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Unspecified Insomnia | 3 Participants |
| Placebo-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Diarrhea | 2 Participants |
| Placebo-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Agitation | 3 Participants |
| Placebo-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Dry Mouth | 2 Participants |
| Placebo-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Rash | 3 Participants |
| Placebo-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Increased Appetite | 0 Participants |
| Placebo-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Vomiting or Nausea | 1 Participants |
| Placebo-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Saliva Hypersecretion | 0 Participants |
| Placebo-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Depressed Mood | 1 Participants |
| Placebo-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Aggression | 8 Participants |
| Placebo-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Pruritus | 1 Participants |
| Placebo-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Nasal Congestion | 6 Participants |
| Placebo-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Middle Insomnia | 0 Participants |
| Placebo-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Dizziness | 1 Participants |
| Placebo-Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Decreased Appetite | 3 Participants |
| Placebo-Placebo | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Diarrhea | 3 Participants |
| Placebo-Placebo | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Decreased Appetite | 1 Participants |
| Placebo-Placebo | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Saliva Hypersecretion | 1 Participants |
| Placebo-Placebo | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Rash | 2 Participants |
| Placebo-Placebo | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Vomiting or Nausea | 1 Participants |
| Placebo-Placebo | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Headache | 3 Participants |
| Placebo-Placebo | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Nasal Congestion | 13 Participants |
| Placebo-Placebo | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Hyperactivity | 1 Participants |
| Placebo-Placebo | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Unspecified Insomnia | 0 Participants |
| Placebo-Placebo | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Depressed Mood | 2 Participants |
| Placebo-Placebo | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Aggression | 10 Participants |
| Placebo-Placebo | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Middle Insomnia | 0 Participants |
| Placebo-Placebo | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Pruritus | 0 Participants |
| Placebo-Placebo | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Dizziness | 1 Participants |
| Placebo-Placebo | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Initial Insomnia | 0 Participants |
| Placebo-Placebo | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Constipation | 4 Participants |
| Placebo-Placebo | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Agitation | 3 Participants |
| Placebo-Placebo | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Increased Appetite | 1 Participants |
| Placebo-Placebo | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Dry Mouth | 0 Participants |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Pruritus | 0 Participants |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Dry Mouth | 0 Participants |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Increased Appetite | 0 Participants |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Unspecified Insomnia | 0 Participants |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Aggression | 5 Participants |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Dizziness | 0 Participants |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Constipation | 2 Participants |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Diarrhea | 1 Participants |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Saliva Hypersecretion | 0 Participants |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Vomiting or Nausea | 0 Participants |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Decreased Appetite | 1 Participants |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Agitation | 2 Participants |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Headache | 0 Participants |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Initial Insomnia | 0 Participants |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Middle Insomnia | 0 Participants |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Depressed Mood | 2 Participants |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Hyperactivity | 0 Participants |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Nasal Congestion | 5 Participants |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Rash | 1 Participants |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Diarrhea | 2 Participants |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Rash | 3 Participants |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Initial Insomnia | 0 Participants |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Pruritus | 0 Participants |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Dizziness | 0 Participants |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Vomiting or Nausea | 2 Participants |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Depressed Mood | 1 Participants |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Aggression | 8 Participants |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Unspecified Insomnia | 2 Participants |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Agitation | 2 Participants |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Dry Mouth | 1 Participants |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Saliva Hypersecretion | 0 Participants |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Decreased Appetite | 2 Participants |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Constipation | 4 Participants |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Nasal Congestion | 6 Participants |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Headache | 5 Participants |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Increased Appetite | 0 Participants |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Middle Insomnia | 1 Participants |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Hyperactivity | 1 Participants |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Decreased Appetite | 0 Participants |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Increased Appetite | 0 Participants |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Diarrhea | 1 Participants |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Agitation | 3 Participants |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Constipation | 1 Participants |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Headache | 4 Participants |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Dizziness | 0 Participants |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Initial Insomnia | 1 Participants |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Pruritus | 0 Participants |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Unspecified Insomnia | 0 Participants |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Aggression | 7 Participants |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Depressed Mood | 1 Participants |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Hyperactivity | 0 Participants |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Middle Insomnia | 1 Participants |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Rash | 2 Participants |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Saliva Hypersecretion | 0 Participants |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Nasal Congestion | 10 Participants |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Vomiting or Nausea | 3 Participants |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Dry Mouth | 0 Participants |
| Open-label Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Middle Insomnia | 0 Participants |
| Open-label Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Vomiting or Nausea | 1 Participants |
| Open-label Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Dizziness | 1 Participants |
| Open-label Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Constipation | 0 Participants |
| Open-label Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Pruritus | 1 Participants |
| Open-label Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Headache | 4 Participants |
| Open-label Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Initial Insomnia | 1 Participants |
| Open-label Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Increased Appetite | 1 Participants |
| Open-label Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Decreased Appetite | 0 Participants |
| Open-label Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Saliva Hypersecretion | 0 Participants |
| Open-label Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Hyperactivity | 1 Participants |
| Open-label Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Depressed Mood | 1 Participants |
| Open-label Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Dry Mouth | 0 Participants |
| Open-label Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Aggression | 8 Participants |
| Open-label Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Agitation | 1 Participants |
| Open-label Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Diarrhea | 0 Participants |
| Open-label Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Rash | 1 Participants |
| Open-label Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Nasal Congestion | 7 Participants |
| Open-label Vasopressin | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | Unspecified Insomnia | 0 Participants |
Secondary
Change From Baseline on the Facial Emotion Recognition Test During Treatment.
Score range: 0 to 42; higher scores mean better facial emotion recognition abilities. Lower scores mean worse facial emotion recognition abilities.
Time frame: baseline; 4-week; 8-week
Population: Participants with data at the respective time point
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline on the Facial Emotion Recognition Test During Treatment. | Baseline | 25.2667 score on a scale | Standard Error 1.933 |
| Vasopressin-Vasopressin | Change From Baseline on the Facial Emotion Recognition Test During Treatment. | Change from baseline at 4-week | 0.05134 score on a scale | Standard Error 1.0362 |
| Vasopressin-Vasopressin | Change From Baseline on the Facial Emotion Recognition Test During Treatment. | 4-week | 26.3341 score on a scale | Standard Error 1.9736 |
| Vasopressin-Vasopressin | Change From Baseline on the Facial Emotion Recognition Test During Treatment. | Change from 4-week at 8-week | 2.3733 score on a scale | Standard Error 1.0904 |
| Placebo-Vasopressin | Change From Baseline on the Facial Emotion Recognition Test During Treatment. | Change from 4-week at 8-week | -0.5105 score on a scale | Standard Error 0.8605 |
| Placebo-Vasopressin | Change From Baseline on the Facial Emotion Recognition Test During Treatment. | Baseline | 30.3913 score on a scale | Standard Error 1.561 |
| Placebo-Vasopressin | Change From Baseline on the Facial Emotion Recognition Test During Treatment. | 4-week | 30.3846 score on a scale | Standard Error 1.5814 |
| Placebo-Vasopressin | Change From Baseline on the Facial Emotion Recognition Test During Treatment. | Change from baseline at 4-week | 0.2458 score on a scale | Standard Error 0.8136 |
| Placebo-Placebo | Change From Baseline on the Facial Emotion Recognition Test During Treatment. | Change from 4-week at 8-week | 1.7945 score on a scale | Standard Error 0.8736 |
| Placebo-Placebo | Change From Baseline on the Facial Emotion Recognition Test During Treatment. | Change from baseline at 4-week | -0.1705 score on a scale | Standard Error 0.8543 |
| Placebo-Placebo | Change From Baseline on the Facial Emotion Recognition Test During Treatment. | 4-week | 30.7990 score on a scale | Standard Error 1.6449 |
| Placebo-Placebo | Change From Baseline on the Facial Emotion Recognition Test During Treatment. | Baseline | 31.3333 score on a scale | Standard Error 1.6336 |
Secondary
Change From Baseline on Urine Clinical Labs (Osmolality) During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline on Urine Clinical Labs (Osmolality) During Treatment. | 8-weeks (end of treatment period 2) | 834 mOsm/kg | Standard Error 68.3 |
| Vasopressin-Vasopressin | Change From Baseline on Urine Clinical Labs (Osmolality) During Treatment. | 4-weeks (end of treatment period 1) | 758 mOsm/kg | Standard Error 70.3 |
| Vasopressin-Vasopressin | Change From Baseline on Urine Clinical Labs (Osmolality) During Treatment. | Baseline | 757 mOsm/kg | Standard Error 72.6 |
| Placebo-Vasopressin | Change From Baseline on Urine Clinical Labs (Osmolality) During Treatment. | 8-weeks (end of treatment period 2) | 732 mOsm/kg | Standard Error 48.1 |
| Placebo-Vasopressin | Change From Baseline on Urine Clinical Labs (Osmolality) During Treatment. | 4-weeks (end of treatment period 1) | 810 mOsm/kg | Standard Error 44.8 |
| Placebo-Vasopressin | Change From Baseline on Urine Clinical Labs (Osmolality) During Treatment. | Baseline | 843 mOsm/kg | Standard Error 38.2 |
| Placebo-Placebo | Change From Baseline on Urine Clinical Labs (Osmolality) During Treatment. | 12-weeks (end of open-label extension) | 875 mOsm/kg | Standard Error 60.1 |
| Placebo-Placebo | Change From Baseline on Urine Clinical Labs (Osmolality) During Treatment. | Baseline | 827 mOsm/kg | Standard Error 47.3 |
| Placebo-Placebo | Change From Baseline on Urine Clinical Labs (Osmolality) During Treatment. | 4-weeks (end of treatment period 1) | 815 mOsm/kg | Standard Error 45.5 |
| Placebo-Placebo | Change From Baseline on Urine Clinical Labs (Osmolality) During Treatment. | 8-weeks (end of treatment period 2) | 838 mOsm/kg | Standard Error 47.9 |
Secondary
Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment.
Time frame: Up to 12 weeks
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. | Change from standing to sitting | 4.90 mmHg | Standard Error 3.02 |
| Vasopressin-Vasopressin | Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. | Standing | 70.7 mmHg | Standard Error 3.08 |
| Vasopressin-Vasopressin | Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. | Sitting | 65.8 mmHg | Standard Error 3.47 |
| Placebo-Vasopressin | Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. | Standing | 62.3 mmHg | Standard Error 1.72 |
| Placebo-Vasopressin | Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. | Sitting | 63.4 mmHg | Standard Error 1.34 |
| Placebo-Vasopressin | Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. | Change from standing to sitting | -1.11 mmHg | Standard Error 1.84 |
| Placebo-Placebo | Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. | Change from standing to sitting | 0.167 mmHg | Standard Error 1.6 |
| Placebo-Placebo | Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. | Sitting | 67.2 mmHg | Standard Error 1.79 |
| Placebo-Placebo | Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. | Standing | 67.0 mmHg | Standard Error 1.57 |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. | Standing | 68.8 mmHg | Standard Error 1.41 |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. | Sitting | 69.3 mmHg | Standard Error 3.75 |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. | Change from standing to sitting | -1.00 mmHg | Standard Error 3.96 |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. | Standing | 65.5 mmHg | Standard Error 1.58 |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. | Sitting | 63.6 mmHg | Standard Error 1.42 |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. | Change from standing to sitting | 1.72 mmHg | Standard Error 1.59 |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. | Sitting | 66.9 mmHg | Standard Error 1.75 |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. | Change from standing to sitting | -0.118 mmHg | Standard Error 2.11 |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. | Standing | 66.6 mmHg | Standard Error 1.96 |
| Open-label Vasopressin | Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. | Change from standing to sitting | 2.65 mmHg | Standard Error 2.49 |
| Open-label Vasopressin | Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. | Standing | 67.8 mmHg | Standard Error 1.8 |
| Open-label Vasopressin | Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. | Sitting | 65.1 mmHg | Standard Error 2.11 |
Secondary
Change From Baseline on Vital Signs (Pulse) During Treatment.
Time frame: Up to 12 weeks
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline on Vital Signs (Pulse) During Treatment. | Standing | 99.6 beats per minute (BPM) | Standard Error 3.02 |
| Vasopressin-Vasopressin | Change From Baseline on Vital Signs (Pulse) During Treatment. | Change from standing to sitting | 11.2 beats per minute (BPM) | Standard Error 2.25 |
| Vasopressin-Vasopressin | Change From Baseline on Vital Signs (Pulse) During Treatment. | Sitting | 88.4 beats per minute (BPM) | Standard Error 3.4 |
| Placebo-Vasopressin | Change From Baseline on Vital Signs (Pulse) During Treatment. | Change from standing to sitting | 10.6 beats per minute (BPM) | Standard Error 1.37 |
| Placebo-Vasopressin | Change From Baseline on Vital Signs (Pulse) During Treatment. | Standing | 94.8 beats per minute (BPM) | Standard Error 2.39 |
| Placebo-Vasopressin | Change From Baseline on Vital Signs (Pulse) During Treatment. | Sitting | 84.2 beats per minute (BPM) | Standard Error 2.11 |
| Placebo-Placebo | Change From Baseline on Vital Signs (Pulse) During Treatment. | Sitting | 94.3 beats per minute (BPM) | Standard Error 2.45 |
| Placebo-Placebo | Change From Baseline on Vital Signs (Pulse) During Treatment. | Change from standing to sitting | 10.1 beats per minute (BPM) | Standard Error 1.65 |
| Placebo-Placebo | Change From Baseline on Vital Signs (Pulse) During Treatment. | Standing | 103 beats per minute (BPM) | Standard Error 2.43 |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on Vital Signs (Pulse) During Treatment. | Change from standing to sitting | 10.9 beats per minute (BPM) | Standard Error 2.29 |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on Vital Signs (Pulse) During Treatment. | Sitting | 89.2 beats per minute (BPM) | Standard Error 4.06 |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on Vital Signs (Pulse) During Treatment. | Standing | 100 beats per minute (BPM) | Standard Error 4.01 |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on Vital Signs (Pulse) During Treatment. | Change from standing to sitting | 11.9 beats per minute (BPM) | Standard Error 1.77 |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on Vital Signs (Pulse) During Treatment. | Sitting | 90.0 beats per minute (BPM) | Standard Error 2.95 |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on Vital Signs (Pulse) During Treatment. | Standing | 102 beats per minute (BPM) | Standard Error 2.91 |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on Vital Signs (Pulse) During Treatment. | Standing | 105 beats per minute (BPM) | Standard Error 3.44 |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on Vital Signs (Pulse) During Treatment. | Sitting | 90.7 beats per minute (BPM) | Standard Error 2.4 |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on Vital Signs (Pulse) During Treatment. | Change from standing to sitting | 14.2 beats per minute (BPM) | Standard Error 2.41 |
| Open-label Vasopressin | Change From Baseline on Vital Signs (Pulse) During Treatment. | Standing | 107 beats per minute (BPM) | Standard Error 3.98 |
| Open-label Vasopressin | Change From Baseline on Vital Signs (Pulse) During Treatment. | Sitting | 94.9 beats per minute (BPM) | Standard Error 3.95 |
| Open-label Vasopressin | Change From Baseline on Vital Signs (Pulse) During Treatment. | Change from standing to sitting | 11.2 beats per minute (BPM) | Standard Error 2.84 |
Secondary
Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment.
Time frame: Up to 12 weeks
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. | Change from standing to sitting | -3.25 mmHg | Standard Error 2.16 |
| Vasopressin-Vasopressin | Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. | Standing | 110 mmHg | Standard Error 2.13 |
| Vasopressin-Vasopressin | Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. | Sitting | 114 mmHg | Standard Error 2.78 |
| Placebo-Vasopressin | Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. | Standing | 109 mmHg | Standard Error 1.99 |
| Placebo-Vasopressin | Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. | Sitting | 107 mmHg | Standard Error 2.38 |
| Placebo-Vasopressin | Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. | Change from standing to sitting | 1.47 mmHg | Standard Error 1.67 |
| Placebo-Placebo | Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. | Change from standing to sitting | -1.00 mmHg | Standard Error 1.44 |
| Placebo-Placebo | Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. | Sitting | 112 mmHg | Standard Error 1.58 |
| Placebo-Placebo | Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. | Standing | 111 mmHg | Standard Error 1.71 |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. | Change from standing to sitting | -4.06 mmHg | Standard Error 3.86 |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. | Sitting | 111 mmHg | Standard Error 3.32 |
| Vasopressin-Vasopressin Group - Treatment Period 2 | Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. | Standing | 108 mmHg | Standard Error 2.44 |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. | Standing | 107 mmHg | Standard Error 1.79 |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. | Sitting | 109 mmHg | Standard Error 2.22 |
| Placebo-Vasopressin Group - Treatment Period 2 | Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. | Change from standing to sitting | -2.53 mmHg | Standard Error 1.34 |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. | Standing | 112 mmHg | Standard Error 2.47 |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. | Sitting | 110 mmHg | Standard Error 1.96 |
| Placebo-Placebo Group - Treatment Period 2 | Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. | Change from standing to sitting | 1.47 mmHg | Standard Error 1.69 |
| Open-label Vasopressin | Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. | Change from standing to sitting | 2.04 mmHg | Standard Error 1.71 |
| Open-label Vasopressin | Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. | Standing | 113 mmHg | Standard Error 2.13 |
| Open-label Vasopressin | Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. | Sitting | 111 mmHg | Standard Error 2.03 |
Secondary
Change From Baseline on Weight During Treatment.
Time frame: baseline to 4-week, 8-week, and 12-week
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vasopressin-Vasopressin | Change From Baseline on Weight During Treatment. | 8-weeks (end of treatment period 2) | 43.0 kg | Standard Error 4.83 |
| Vasopressin-Vasopressin | Change From Baseline on Weight During Treatment. | 4-weeks (end of treatment period 1) | 43.9 kg | Standard Error 4.47 |
| Vasopressin-Vasopressin | Change From Baseline on Weight During Treatment. | Baseline | 43.2 kg | Standard Error 3.92 |
| Placebo-Vasopressin | Change From Baseline on Weight During Treatment. | 8-weeks (end of treatment period 2) | 44.0 kg | Standard Error 3.38 |
| Placebo-Vasopressin | Change From Baseline on Weight During Treatment. | 4-weeks (end of treatment period 1) | 46.6 kg | Standard Error 4.92 |
| Placebo-Vasopressin | Change From Baseline on Weight During Treatment. | Baseline | 45.2 kg | Standard Error 4.24 |
| Placebo-Placebo | Change From Baseline on Weight During Treatment. | 12-weeks (end of open-label extension) | 47.6 kg | Standard Error 4.34 |
| Placebo-Placebo | Change From Baseline on Weight During Treatment. | Baseline | 45.7 kg | Standard Error 3.15 |
| Placebo-Placebo | Change From Baseline on Weight During Treatment. | 4-weeks (end of treatment period 1) | 46.6 kg | Standard Error 3.17 |
| Placebo-Placebo | Change From Baseline on Weight During Treatment. | 8-weeks (end of treatment period 2) | 46.8 kg | Standard Error 3.22 |
Other Pre-specified
Change From Baseline in Parent Rated Anxiety Scale - Autism Spectrum Disorder (PRAS-ASD) Score During Treatment.
Time frame: 4-week; 8-week
Other Pre-specified
Change From Baseline in Parent Rated Child's Sleep Habits Questionnaire (CSHQ) Score During Treatment.
Time frame: 4-week; 8-week
Other Pre-specified
Change From Baseline in Parent Rated Pediatric Quality of Life (PedsQL) Inventory Scores During Treatment.
Time frame: 4-week; 8-week
Other Pre-specified
Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Attachment and Affiliation Factor Score During Treatment.
Time frame: 4-week; 8-week
Other Pre-specified
Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Emotion Recognition Factor Score During Treatment.
Time frame: 4-week; 8-week
Other Pre-specified
Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Facial Communication Production Factor Score During Treatment.
Time frame: 4-week; 8-week
Other Pre-specified
Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Insistence On Sameness Factor Score During Treatment.
Time frame: 4-week; 8-week
Other Pre-specified
Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Interpersonal Relatedness Factor Score During Treatment.
Time frame: 4-week; 8-week
Other Pre-specified
Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Mental States Understanding Factor Score During Treatment.
Time frame: 4-week; 8-week
Other Pre-specified
Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Non-facial Communication Production Factor Score During Treatment.
Time frame: 4-week; 8-week
Other Pre-specified
Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Repetitive Mannerisms Factor Score During Treatment.
Time frame: 4-week; 8-week
Other Pre-specified
Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Social Avoidance Factor Score During Treatment.
Time frame: 4-week; 8-week
Other Pre-specified
Change From Baseline in Parent Rated Stanford Social Motivation Scale (Also Known as the Stanford Social Dimensional Scale) Total Scores During Treatment.
Time frame: 4-week; 8-week
Other Pre-specified
Change From Baseline in Vineland Adaptive Behavior Scales, Third Edition (VABS-3) - Social Skills and Relationships Domain During Treatment.
Time frame: 4-week; 8-week
Other Pre-specified
Change From Baseline on Eye Gaze Assessment (Eye Tracking) During Treatment.
Time frame: 4-week; 8-week
Other Pre-specified
Change From Baseline on Spectral Power in the Alpha, Theta, and Gamma Frequencies as Measured by Electroencephalogram (EEG) During Treatment.
Time frame: 4-week; 8-week
Other Pre-specified
Change From Baseline on the Developmental Neuropsychological Assessment, Second Edition (NEPSY-II) Theory of Mind Test During Treatment.
Time frame: 4-week; 8-week
Other Pre-specified
Change From Baseline the Diagnostic Analysis of Nonverbal Accuracy, Second Edition (DANVA-2) Child Voices Prosody Test During Treatment.
Time frame: 4-week; 8-week