Schizophrenia Spectrum and Other Psychotic Disorders
Conditions
Brief summary
Schizophrenia (SZ) is a highly debilitating neuropsychiatric disorder of young adulthood onset and a leading cause of disability worldwide. While treatments delivered at early stages of the disorder may be effective at reducing psychosis or altering the course of the disease, there are currently no biomarkers capable of identifying subjects in early stages of SZ who are likely to respond to treatment and would be good candidates for available proactive, symptomatic or future disease-modifying treatments; or those who would not respond and can be spared unnecessary medication exposure. The lack of these vitally important biomarkers provides a compelling rationale for the present multidisciplinary research project, which aims to develop and validate highly promising noninvasive and objective proton magnetic resonance spectroscopy (1H MRS)-based biomarkers for monitoring treatment response in early stages of SZ. In support of the viability of this overall objective is a large body of data, reported by the applicants and others, that show (a) that levels of glutamate (Glu) and - aminobutyric acid (GABA) - respectively, the major excitatory and inhibitory amino acid neurotransmitter systems - are abnormally elevated in medication-naïve and unmedicated first episode and chronic SZ patients; (b) that the effect of treatment with antipsychotic medications in these populations may be to lower or normalize brain levels of both Glu and GABA. To investigate the potential of these in vivo brain Glu and GABA abnormalities to serve as biomarkers of treatment response in early-stage SZ, the applicants propose to use 1H MRS to measure Glu and GABA levels in the largest cohort of medication-free SZ subjects to date, at baseline and following 4 weeks of antipsychotic treatment.
Interventions
DRUGRisperidone
Participants will meet with a study doctor physician once per week (about 3 times total) to monitor progress and side-effects of risperidone, which includes taking 4 assessments each time. After 4 weeks of taking Risperidone, participant will be assessed and scanned with the MRI/MRS scanner again.
Sponsors
New York State Psychiatric Institute
Columbia University
National Institute of Mental Health (NIMH)
Weill Medical College of Cornell University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
(Patients): 1. Male or females between the ages of 18-35 2. less than five years (\<60 months) of active Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder 3. Capacity to provide informed consent 4. No major medical or neurological illness 5. Medication free (3 weeks without antipsychotic medications)
Exclusion criteria
(Patients): 1. Current alcohol or drug abuse (\<1 month) or substance dependence (\<6 months) or substances used within one day of the imaging study. 2. Pregnant or lactating women or women of child-bearing potential, who are either not surgically-sterile or, for outpatients, not using appropriate methods of birth control. 3. Intelligence Quotient (IQ) \<70 4. Acute risk for suicide or violence 5. Presence of pacemaker or any metallic objects in the body that would interfere with the MRS or cause MRI safety problems 6. Claustrophobia 7. Any organic brain disorder (including epilepsy, mental retardation, or a medical condition whose pathology or treatment would likely alter the presentation or treatment of SZ 8. Individuals on anti-epileptic medications (e.g., valproate, carbamazepine) that may affect GABA or Glu 9. Unstable medical or neurological condition 10. DSM-V diagnosis of bipolar disorder I 11. DSM-V diagnosis of major depression with psychotic features 12. History of non-response to or non-tolerance of Risperidone Inclusion Criteria (Healthy Controls) 1. Male or females between the ages of 18-35 2. less than five years (\<60 months) of active DSM diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder 3. No major medical or neurological illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Biomarkers of Treatment Response: Dorsal Caudate (DCA) Gamma Amino Butyric Acid (GABA) Levels | Baseline and 4 weeks of treatment for patients, baseline for controls | Dorsal Caudate (DCA) GABA levels will be ascertained at baseline and after 4 weeks of treatment using MRI scan with 1H MRS to assess treatment response. This is a measure of GABA levels, over water, in the dorsal caudate. For patients this is a change measure. For control subjects, this is a one time measure. The values can range from 0 to infinity for controls and -infinity to infinity for patients. |
| Change in Biomarkers of Treatment Response: Dorsal Caudate (DCA) Glx (Glutamate+Glutamine) | Baseline and 4th week of treatment for patients, baseline only for controls | Dorsal Caudate (DCA) Glx levels will be ascertained at baseline and after 4 weeks of treatment using MRI scan with 1H MRS to assess treatment response. This is a measure of the levels of Glx over water in the dorsal caudate. For patients this is a change measure. For control subjects, this is a one time measure. The values can range from 0 to infinity for controls and -infinity to infinity for patients. |
| Change in Biomarkers Reflecting Treatment Response: Medial Prefrontal Cortex (MPFC) Gamma Amino Butyric Acid (GABA) | Baseline and 4th week of treatment for patients, baseline only for controls | Medial Prefrontal Cortex (MPFC) GABA levels will be ascertained at baseline and after 4 weeks of treatment using MRI scan with 1H MRS to assess treatment response. This is a measure of GABA levels, over water, in the mPFC. For patients this is a change measure. For control subjects, this is a one time measure. The values can range from 0 to infinity for controls and -infinity to infinity for patients. |
| Change in Biomarkers Reflecting Treatment Response: Medial Prefrontal Cortex (MPFC) Glx (Glutamate+Glutamine) | Baseline and 4th week of treatment for patients, baseline for controls | Medial Prefrontal Cortex (MPFC) Glx levels will be ascertained at baseline and after 4 weeks of treatment using MRI scan with 1H MRS to assess treatment response. This is a measure of glx levels, over water, in the mPFC. For patients this is a change measure. For control subjects, this is a one time measure. The values can range from 0 to infinity for controls and -infinity to infinity for patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Clinical Severity: Clinical Global Impression Scale | Baseline and week 4 for patients; for controls this is a baseline measure only | Changes in clinical severity over the course of treatment will be monitored using the The Clinical Global Impression Scale (CGI) consists of two items.- Severity scale (CGI-S). Severity - The first item assesses the patient's current level of mental health symptomatology compared to the clinician's experience with other patients with the same diagnosis. The scale ranges from 1. (Normal, not at all ill) 2. (Borderline mentally ill) 3. (Mildly ill) 4. (Moderately ill) 5. (Markedly ill) 6. (Severely ill) 7. (Among the most extremely ill patients) Improvement - The second item assesses how much the patient's symptomatology has changed since the last clinical visit. 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse For patients this is a change measure. For control subjects, this is a one time measure. The possible score range is 1-7 with 1 being least and 7 being most symptomatic. |
| Changes in Global Functioning: Global Assessment of Functioning (GAF) | Baseline and week 4 for patients; for controls only baseline | Changes in global functioning over the course of treatment will be assessed using the Global Assessment of Functioning (GAF). Participants are rated 1-100 on their level of functioning, according to clinical observation: 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 If symptoms are present, they expected reactions to stressors 61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Impairment in reality testing or communication or major impairment in several areas 21-30 Behavior influenced by delusions or hallucinations or serious impairment in communication/judgment/inability to function in almost all areas 11-20 Some danger of hurting self or others or occasionally fails to maintain minimal personal hygiene or gross impairment in communication 1-10 Persistent violence risk or lack of self-care 0 No info For patients this is a change measure. For control subjects, this is a one time measure. |
| Changes in Neurocognitive Performance: MATRICS Consensus Cognitive Battery (MCCB) | Baseline and 4th week of of treatment for patients, baseline only for controls | Memory, attention, reasoning, emotional intelligence, and verbal ability will be assessed using the MCCB before and after 4 weeks of treatment. MATRICS Consensus Cognitive Battery (MCCB) as measure of Neurocognitive/Functional Measures is a standardized battery designed to measure cognitive functioning in people with schizophrenia. The MCCB is represented as a percentile score. This score can go from 0 to 100 where a higher score indicates a better performance. For patients this is a change measure. For control subjects, this is a one time measure. |
| Participants' Verbal I.Q (Intelligence Quotient) as Assessed by the WTAR (Wechsler Test of Adult Reading) to Determine Clinical Eligibility | This measure is completed on Day 1 of the study. | This measure assesses a participant's verbal ability to determine whether they are cognitively able to complete the measures involved in the study. The participant will read from a list of 50 English words and the rater will record whether the pronunciation was correct on a score card for each word spoken. A standard score below the 70th percentile on this measure is indicative of an intellectual disability which would exclude a participant from being clinically and cognitively eligible to complete this study. The potential score range is 0-50. A higher score indicates better cognitive ability. There is only one total score. |
| Participants' Self-Reported Handedness as Recorded by the Edinburgh Handedness Scale (Predominantly Right) | This measure is completed on Day 1 of the study. | This measure assesses a participant's preference regarding which hand they would use to complete a specific task. They have the option to indicate whether they would use they would always or most of the time use their left, right, or both left and right hands to complete each task. This measure assesses handedness based on the amount of responses which indicate the participant is either left handed, right handed, or ambidextrous. Below we specifically report on the number of individuals who were predominantly right handed. |
| Recreational Substances Used by Patients as Recorded by the Substance Use Questionnaire | This measure is administered on Day 1 of the study. | This measure is a self-reported questionnaire which assesses for any use of the following substances within the past month prior to the initial research visit Tobacco (if the respondent indicates that they have used tobacco in the past month, they are additionally asked, On average, how many cigarettes per day have you smoked in the past 7 days? Alcohol, Cocaine, Marijuana, Opiates, Amphetamines, phencyclidine (PCP) Other Drugs of Abuse (if the respondent indicates they have used other drugs of abuse within the past month of the initial research visit, they are given the opportunity to specify which other drugs of abuse they used |
| WAMI (Wealth Asset and Income) | Baseline | The WAMI Score at Baseline is a measure of socioeconomic status across countries and culture. The index scale goes from 0 (lower socioeconomic situation) to 1 (highest socioeconomic situation). |
| Changes in Clinical Symptomatology: Positive and Negative Syndrome Scale (PANSS) | Baseline and week 4 for patients; for controls only baseline | Changes in Positive and Negative Symptoms will be assessed across the treatment period using the PANSS. Participants are rated on a scale of 1. (Absent) 2. (Minimal) 3. (Mild) 4. (Moderate) 5. (Moderate severe) 6. (Severe) 7. (Extreme) to describe Positive, Negative and General symptomatology. Items from each subscale (Positive, Negative, and General) are summed for their respective scales, with lower numbers indicating less severe or absent symptomatology, and higher scores indicating more severe symptoms. A total sum of all subscales is also computed to reflect overall symptom severity. Positive Subscale: 7 items, minimum score = 7, maximum score = 49 Negative Subscale: 7 items, minimum score = 7, maximum score = 49 General Subscale: '16 items, minimum score = 16, maximum score = 112 Total Score: 30 items, minimum score = 30, maximum score = 210. For patients this is a change measure. For control subjects, this is a one time measure. |
| Changes in Motor Symptomatology: Abnormal Involuntary Movement Scale (AIMS) | Baseline and week 4 | Motor symptomatology associated with tardive dyskinesia (TD) assessed using the AIMS. The measure consists of 10 items with scale/scores for each item of: 0 None 1. Minimal 2. Mild 3. Moderate 4. Severe Higher ratings = higher levels of motor symptoms which is worse. This scale assesses abnormal movements for parts of the body. The total score is a sum score of items 1-10 and can be 0-40, with 40 being the most symptomatic (i.e., most extrapyramidal side effects, or worse). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patient Medication-free individuals during first-episode of psychosis who will receive 4 weeks of treatment with risperidone
Risperidone: Participants will meet with a study doctor physician once per week (about 3 times total) to monitor progress and side-effects of risperidone, which includes taking 4 assessments each time. After 4 weeks of taking Risperidone, participant will be assessed and scanned with the MRI/MRS scanner again. | 13 |
| Control Healthy, psychosis-free controls who will not receive risperidone | 9 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 4 |
Baseline characteristics
| Characteristic | Patient | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 9 Participants | 22 Participants |
| Age, Continuous | 23.9 years STANDARD_DEVIATION 3.3 | 26.4 years STANDARD_DEVIATION 2.7 | 24.8 years STANDARD_DEVIATION 3.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 1 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 8 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 5 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 4 Participants | 9 Participants |
| Region of Enrollment United States | 13 participants | 9 participants | 22 participants |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 12 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
Primary
Change in Biomarkers of Treatment Response: Dorsal Caudate (DCA) Gamma Amino Butyric Acid (GABA) Levels
Dorsal Caudate (DCA) GABA levels will be ascertained at baseline and after 4 weeks of treatment using MRI scan with 1H MRS to assess treatment response. This is a measure of GABA levels, over water, in the dorsal caudate. For patients this is a change measure. For control subjects, this is a one time measure. The values can range from 0 to infinity for controls and -infinity to infinity for patients.
Time frame: Baseline and 4 weeks of treatment for patients, baseline for controls
Population: The number of participants analyzed is lower than the participant flow as data from several subjects were excluded due to MRS quality control issues brought about by unreliable performance of a head coil.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Patient | Change in Biomarkers of Treatment Response: Dorsal Caudate (DCA) Gamma Amino Butyric Acid (GABA) Levels | -0.65 institutional units |
| Control | Change in Biomarkers of Treatment Response: Dorsal Caudate (DCA) Gamma Amino Butyric Acid (GABA) Levels | .0037 institutional units |
p-value: <0.01ANOVA
Primary
Change in Biomarkers of Treatment Response: Dorsal Caudate (DCA) Glx (Glutamate+Glutamine)
Dorsal Caudate (DCA) Glx levels will be ascertained at baseline and after 4 weeks of treatment using MRI scan with 1H MRS to assess treatment response. This is a measure of the levels of Glx over water in the dorsal caudate. For patients this is a change measure. For control subjects, this is a one time measure. The values can range from 0 to infinity for controls and -infinity to infinity for patients.
Time frame: Baseline and 4th week of treatment for patients, baseline only for controls
Population: The number of participants analyzed is lower than the participant flow as data from several subjects were excluded due to MRS quality control issues brought about by unreliable performance of a head coil.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Patient | Change in Biomarkers of Treatment Response: Dorsal Caudate (DCA) Glx (Glutamate+Glutamine) | -.28 institutional units |
| Control | Change in Biomarkers of Treatment Response: Dorsal Caudate (DCA) Glx (Glutamate+Glutamine) | .00221 institutional units |
p-value: 0.68ANOVA
Primary
Change in Biomarkers Reflecting Treatment Response: Medial Prefrontal Cortex (MPFC) Gamma Amino Butyric Acid (GABA)
Medial Prefrontal Cortex (MPFC) GABA levels will be ascertained at baseline and after 4 weeks of treatment using MRI scan with 1H MRS to assess treatment response. This is a measure of GABA levels, over water, in the mPFC. For patients this is a change measure. For control subjects, this is a one time measure. The values can range from 0 to infinity for controls and -infinity to infinity for patients.
Time frame: Baseline and 4th week of treatment for patients, baseline only for controls
Population: The number of participants analyzed is lower than the participant flow as data from several subjects were excluded due to MRS quality control issues brought about by unreliable performance of a head coil.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Patient | Change in Biomarkers Reflecting Treatment Response: Medial Prefrontal Cortex (MPFC) Gamma Amino Butyric Acid (GABA) | .85 institutional units |
| Control | Change in Biomarkers Reflecting Treatment Response: Medial Prefrontal Cortex (MPFC) Gamma Amino Butyric Acid (GABA) | .00247 institutional units |
p-value: 0.03ANOVA
Primary
Change in Biomarkers Reflecting Treatment Response: Medial Prefrontal Cortex (MPFC) Glx (Glutamate+Glutamine)
Medial Prefrontal Cortex (MPFC) Glx levels will be ascertained at baseline and after 4 weeks of treatment using MRI scan with 1H MRS to assess treatment response. This is a measure of glx levels, over water, in the mPFC. For patients this is a change measure. For control subjects, this is a one time measure. The values can range from 0 to infinity for controls and -infinity to infinity for patients.
Time frame: Baseline and 4th week of treatment for patients, baseline for controls
Population: The number of participants analyzed is lower than the participant flow as data from several subjects were excluded due to MRS quality control issues brought about by unreliable performance of a head coil.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Patient | Change in Biomarkers Reflecting Treatment Response: Medial Prefrontal Cortex (MPFC) Glx (Glutamate+Glutamine) | 0.19 institutional units |
| Control | Change in Biomarkers Reflecting Treatment Response: Medial Prefrontal Cortex (MPFC) Glx (Glutamate+Glutamine) | .00191 institutional units |
p-value: 0.01ANOVA
Secondary
Changes in Clinical Severity: Clinical Global Impression Scale
Changes in clinical severity over the course of treatment will be monitored using the The Clinical Global Impression Scale (CGI) consists of two items.- Severity scale (CGI-S). Severity - The first item assesses the patient's current level of mental health symptomatology compared to the clinician's experience with other patients with the same diagnosis. The scale ranges from 1. (Normal, not at all ill) 2. (Borderline mentally ill) 3. (Mildly ill) 4. (Moderately ill) 5. (Markedly ill) 6. (Severely ill) 7. (Among the most extremely ill patients) Improvement - The second item assesses how much the patient's symptomatology has changed since the last clinical visit. 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse For patients this is a change measure. For control subjects, this is a one time measure. The possible score range is 1-7 with 1 being least and 7 being most symptomatic.
Time frame: Baseline and week 4 for patients; for controls this is a baseline measure only
Population: The number of participants analyzed is lower than the participant flow as some subjects did not complete all measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient | Changes in Clinical Severity: Clinical Global Impression Scale | -0.054 score on a scale | Standard Deviation 0.1 |
| Control | Changes in Clinical Severity: Clinical Global Impression Scale | 1 score on a scale | Standard Deviation 0 |
p-value: 0.34ANOVA
Secondary
Changes in Clinical Symptomatology: Positive and Negative Syndrome Scale (PANSS)
Changes in Positive and Negative Symptoms will be assessed across the treatment period using the PANSS. Participants are rated on a scale of 1. (Absent) 2. (Minimal) 3. (Mild) 4. (Moderate) 5. (Moderate severe) 6. (Severe) 7. (Extreme) to describe Positive, Negative and General symptomatology. Items from each subscale (Positive, Negative, and General) are summed for their respective scales, with lower numbers indicating less severe or absent symptomatology, and higher scores indicating more severe symptoms. A total sum of all subscales is also computed to reflect overall symptom severity. Positive Subscale: 7 items, minimum score = 7, maximum score = 49 Negative Subscale: 7 items, minimum score = 7, maximum score = 49 General Subscale: '16 items, minimum score = 16, maximum score = 112 Total Score: 30 items, minimum score = 30, maximum score = 210. For patients this is a change measure. For control subjects, this is a one time measure.
Time frame: Baseline and week 4 for patients; for controls only baseline
Population: The number of participants analyzed is lower than the participant flow as some subjects were unable to complete all measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient | Changes in Clinical Symptomatology: Positive and Negative Syndrome Scale (PANSS) | -0.09 score on a scale | Standard Deviation 0.15 |
| Control | Changes in Clinical Symptomatology: Positive and Negative Syndrome Scale (PANSS) | 31.89 score on a scale | Standard Deviation 2.98 |
p-value: 0.32ANOVA
Secondary
Changes in Global Functioning: Global Assessment of Functioning (GAF)
Changes in global functioning over the course of treatment will be assessed using the Global Assessment of Functioning (GAF). Participants are rated 1-100 on their level of functioning, according to clinical observation: 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 If symptoms are present, they expected reactions to stressors 61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Impairment in reality testing or communication or major impairment in several areas 21-30 Behavior influenced by delusions or hallucinations or serious impairment in communication/judgment/inability to function in almost all areas 11-20 Some danger of hurting self or others or occasionally fails to maintain minimal personal hygiene or gross impairment in communication 1-10 Persistent violence risk or lack of self-care 0 No info For patients this is a change measure. For control subjects, this is a one time measure.
Time frame: Baseline and week 4 for patients; for controls only baseline
Population: The number of participants analyzed is lower than the participant flow as some subjects did not complete this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient | Changes in Global Functioning: Global Assessment of Functioning (GAF) | 0.21 score on a scale | Standard Deviation 0.2 |
| Control | Changes in Global Functioning: Global Assessment of Functioning (GAF) | 86.4 score on a scale | Standard Deviation 8.53 |
p-value: 0.35ANOVA
Secondary
Changes in Motor Symptomatology: Abnormal Involuntary Movement Scale (AIMS)
Motor symptomatology associated with tardive dyskinesia (TD) assessed using the AIMS. The measure consists of 10 items with scale/scores for each item of: 0 None 1. Minimal 2. Mild 3. Moderate 4. Severe Higher ratings = higher levels of motor symptoms which is worse. This scale assesses abnormal movements for parts of the body. The total score is a sum score of items 1-10 and can be 0-40, with 40 being the most symptomatic (i.e., most extrapyramidal side effects, or worse).
Time frame: Baseline and week 4
Population: This measure is solely for patients and people who received antipsychotic treatment, so control subjects did not complete this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient | Changes in Motor Symptomatology: Abnormal Involuntary Movement Scale (AIMS) | -.077 score on a scale | Standard Deviation 0.28 |
p-value: 0.6ANOVA
Secondary
Changes in Neurocognitive Performance: MATRICS Consensus Cognitive Battery (MCCB)
Memory, attention, reasoning, emotional intelligence, and verbal ability will be assessed using the MCCB before and after 4 weeks of treatment. MATRICS Consensus Cognitive Battery (MCCB) as measure of Neurocognitive/Functional Measures is a standardized battery designed to measure cognitive functioning in people with schizophrenia. The MCCB is represented as a percentile score. This score can go from 0 to 100 where a higher score indicates a better performance. For patients this is a change measure. For control subjects, this is a one time measure.
Time frame: Baseline and 4th week of of treatment for patients, baseline only for controls
Population: The number of participants analyzed is lower than the participant flow as some subjects did not finish all assessments in the MATRICS necessary to calculate this outcome.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Patient | Changes in Neurocognitive Performance: MATRICS Consensus Cognitive Battery (MCCB) | 0.222 percentile score |
| Control | Changes in Neurocognitive Performance: MATRICS Consensus Cognitive Battery (MCCB) | 42.9 percentile score |
p-value: 0.59t-test, 2 sided
Secondary
Participants' Self-Reported Handedness as Recorded by the Edinburgh Handedness Scale (Predominantly Right)
This measure assesses a participant's preference regarding which hand they would use to complete a specific task. They have the option to indicate whether they would use they would always or most of the time use their left, right, or both left and right hands to complete each task. This measure assesses handedness based on the amount of responses which indicate the participant is either left handed, right handed, or ambidextrous. Below we specifically report on the number of individuals who were predominantly right handed.
Time frame: This measure is completed on Day 1 of the study.
Population: The number of participants analyzed is lower than the participant flow as some subjects did not complete all measures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patient | Participants' Self-Reported Handedness as Recorded by the Edinburgh Handedness Scale (Predominantly Right) | 11 Participants |
| Control | Participants' Self-Reported Handedness as Recorded by the Edinburgh Handedness Scale (Predominantly Right) | 7 Participants |
p-value: 1Fisher Exact
Secondary
Participants' Verbal I.Q (Intelligence Quotient) as Assessed by the WTAR (Wechsler Test of Adult Reading) to Determine Clinical Eligibility
This measure assesses a participant's verbal ability to determine whether they are cognitively able to complete the measures involved in the study. The participant will read from a list of 50 English words and the rater will record whether the pronunciation was correct on a score card for each word spoken. A standard score below the 70th percentile on this measure is indicative of an intellectual disability which would exclude a participant from being clinically and cognitively eligible to complete this study. The potential score range is 0-50. A higher score indicates better cognitive ability. There is only one total score.
Time frame: This measure is completed on Day 1 of the study.
Population: The number of participants analyzed is lower than the participant flow as some subjects did not complete all measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient | Participants' Verbal I.Q (Intelligence Quotient) as Assessed by the WTAR (Wechsler Test of Adult Reading) to Determine Clinical Eligibility | 36.9 score on a scale | Standard Deviation 8.43 |
| Control | Participants' Verbal I.Q (Intelligence Quotient) as Assessed by the WTAR (Wechsler Test of Adult Reading) to Determine Clinical Eligibility | 43.9 score on a scale | Standard Deviation 6.23 |
p-value: 0.04t-test, 2 sided
Secondary
Recreational Substances Used by Patients as Recorded by the Substance Use Questionnaire
This measure is a self-reported questionnaire which assesses for any use of the following substances within the past month prior to the initial research visit Tobacco (if the respondent indicates that they have used tobacco in the past month, they are additionally asked, On average, how many cigarettes per day have you smoked in the past 7 days? Alcohol, Cocaine, Marijuana, Opiates, Amphetamines, phencyclidine (PCP) Other Drugs of Abuse (if the respondent indicates they have used other drugs of abuse within the past month of the initial research visit, they are given the opportunity to specify which other drugs of abuse they used
Time frame: This measure is administered on Day 1 of the study.
Population: The number of participants analyzed is lower than the participant flow as some subjects did not complete all measures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patient | Recreational Substances Used by Patients as Recorded by the Substance Use Questionnaire | 6 Participants |
| Control | Recreational Substances Used by Patients as Recorded by the Substance Use Questionnaire | 4 Participants |
p-value: 0.66Fisher Exact
Secondary
WAMI (Wealth Asset and Income)
The WAMI Score at Baseline is a measure of socioeconomic status across countries and culture. The index scale goes from 0 (lower socioeconomic situation) to 1 (highest socioeconomic situation).
Time frame: Baseline
Population: The number of participants analyzed is lower than the participant flow as some subjects did not complete this assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient | WAMI (Wealth Asset and Income) | .901 score on a scale | Standard Deviation 0.179 |
| Control | WAMI (Wealth Asset and Income) | .982 score on a scale | Standard Deviation 0.027 |
p-value: 0.45t-test, 2 sided