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

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

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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Galantamine
* Other: Placebo-Oxytocin
* Other: Placebo-Galantamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any race Subjects will meet DSM-IV criteria for schizophrenia or schizoaffective disorder Judged clinically stable and will not exceed threshold levels of positive, depressive, and/or extrapyramidal symptoms The minimum level of negative symptoms will be defined as follows: Scale for the Assessment of Negative Symptoms (SANS) total score (minus the global items, and inappropriate affect, poverty of content of speech and attentional items) 20 or greater; OR SANS alogia global item score 3 or greater The maximum level of psychotic, depressive, and extrapyramidal symptoms at the beginning and end of leading in: Brief Psychiatric Rating Scale (BPRS) psychotic factor score (4-items) less or equal to 16 BPRS Anxiety/Depression factor score (4-items) less than or equal to 14 Simpson-Angus-Scale (SAS) total score (13-items) less than or equal to 10 Subjects will be required to be on the same antipsychotic(s) for two months and on the same dose for the last month Exclusion Criteria: Participants with an organic brain disorder; mental retardation; or a medical condition, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol Participants with intermittent alcohol or substance use will not be excluded unless they have met DSM-IV criteria for alcohol or substance abuse (other than nicotine) within the last month. Participants may be treated with one or more antipsychotics, except chlorpromazine, thioridazine, or mesoridazine. These latter antipsychotics are excluded because of the concern that their anticholinergic properties may interfere with the accurate assessment of galantamine efficacy. Participants may not be treated with anticholinergic medications or have clinically significant extrapyramidal symptoms. Additionally, subjects treated with glycopyrrolate will be accepted. Female participants may not be pregnant Female subjects may not be taking olanzapine at doses higher than 30 mg . Male subjects may not be taking olanzapine at doses higher than 40 mg.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1: galantamine/placebo-oxytocin<br>Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | Drug: Galantamine<br>* Galantamine: 4 mg twice a day for 1 week, then 8 mg twice a day for 1 week, then 12 mg twice a day for 4 weeks<br>Other: Placebo-Oxytocin<br>* Saline nasal spray with a total of 6 puffs of the spray, 3 in each nostril at each administration<br>|
| Active Comparator: 2: oxytocin/placebo-galantamine<br>Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | Drug: Oxytocin<br>* Oxytocin: 24 IU in the morning and 24 IU in the evening given by nasal spray with a total of 6 puffs of the spray, 3 in each nostril at each administration<br>Other: Placebo-Galantamine<br>* Placebo tablets twice a day for 6 weeks<br>|
| Placebo Comparator: 3: placebo-galantamine /placebo-oxytocin<br>Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin | Other: Placebo-Oxytocin<br>* Saline nasal spray with a total of 6 puffs of the spray, 3 in each nostril at each administration<br>Other: Placebo-Galantamine<br>* Placebo tablets twice a day for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scale for the Assessment of Negative Symptoms (SANS) - Avolition | Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome. | Every other week for 6 weeks | 
| Scale for the Assessment of Negative Symptoms (SANS) - Anhedonia | Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome. | Every other week for 6 weeks | 
| Scale for the Assessment of Negative Symptoms (SANS) - Alogia | Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome. | Every other week for 6 weeks | 
| Scale for the Assessment of Negative Symptoms (SANS) - Blunted Affect | Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome. | Every other week for 6 weeks | 
| Brief Psychiatric Rating Scale (BPRS) - Total Score | The total BPRS score is calculated by adding the scores for scales #1-#18. Each scale ranges from 1=Not Present to 7=Very Severe. Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating. | Every other week for 6 weeks | 
| Brief Psychiatric Rating Scale (BPRS) - Psychosis Score | The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating. | Every other week for 6 weeks | 
| Calgary Depression Scale (CDS) - Total Score | Total score calculated by adding scores for scales #1-#9. Each scale ranges from 0=Absent to 3=Severe. The minimum total CDS score is 0 and the maximum total CDS score is 27. A higher score indicates a more severe depression rating. | Every other week for 6 weeks | 
| Arizona Sexual Experience Questionnaire (ASEX) Female | Mean ASEX total scores by treatment and week for female participants. Total scores are calculated by adding scores for scales #1-#5. Each scale ranges from 1=Easily/Extremely to 6=Never/None. The minimum total ASEX score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences. | Once during evaluation and once at the end of 6 weeks of study treatment | 
| Arizona Sexual Experience Questionnaire (ASEX) Male | Mean ASEX total scores by treatment and week for male participants. Total scores are calculated by adding scores for scales #1-#5. Total scores are calculated by adding scores for scales #1-#5. Each scale ranges from 1=Easily/Extremely to 6=Never/None. The minimum total ASEX score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences. | Once during evaluation and once at the end of 6 weeks of study treatment | 
| Vital Signs - Diastolic Blood Pressure | Mean diastolic blood pressure by treatment and follow-up week | Weekly for 6 weeks | 
| Vital Signs - Systolic Blood Pressure | Mean systolic blood pressure by treatment and follow-up week | Weekly for 6 weeks | 
| Vital Signs - Weight | Mean weight (kg) by treatment and follow-up week | Weekly for 6 weeks | 
| Vital Signs - Pulse | Mean sitting pulse (bpm) by treatment and follow-up week | Weekly for 6 weeks | 
| Simpson-Angus Scale (SAS) | SAS total score for extrapyramidal side effects: Frequencies of greatest within-participant increase (worsening) from pre-treatment baseline, by treatment group. Total scores calculated by adding scores from scales #1-#11. Each scale ranges from 0=None/Normal to 4=Extreme/Severe. The minimum total score is 0 and the maximum score is 44. Higher scores indicate a more severe extrapyramidal side effect rating. | Baseline, week 3, and week 6 | 
| Abnormal Involuntary Movement Scale (AIMS) | AIMS Total Score: Frequencies of Maximum Within- Participant Increases (worsening) from Baseline by Treatment Group. Total score calculated by adding scores from scales #1-#10. Each scale ranges from 0=None to 4=Severe. The minimum total AIMS score is 0 and the maximum score is 40. Higher scores indicate a more severe abnormal involuntary movement rating. | Treatment Week 0 and Week 6 | 
| Electrocardiogram (EKG) | Mean corrected QT interval (QTc) by study week and treatment. | Once during Evaluation and once at Treatment Week 6 | 
| Barnes Akathisia Scale (BAS) - Global Score | For each subject, the largest increase from baseline in the global akathisia score at any visit during follow-up was calculated. The global akathisia score ranges from 0=Absent to 5=Severe Akathisia. Higher scores indicate a more severe global rating of akathisia. | Treatment Week 0 and Week 6 | 
| Blood Oxytocin Levels | Blood Oxytocin Levels by Treatment and Visit | Treatment Week 0 and Week 6 | 
| Laboratory Measures - ALT/SGPT | Alanine transaminase/serum glutamic-pyruvic transaminase (ALT/SGPT) blood levels by treatment group and visit. | Once during evaluation and once at the end of 6 weeks of study treatment | 
| Laboratory Measures - AST/SGOT | Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) blood levels by treatment group and visit. | Once during evaluation and once at the end of 6 weeks of study treatment | 
| Laboratory Measures - Alkaline Phosphatase | Alkaline phosphatase blood level by treatment group and visit. | Once during evaluation and once at the end of 6 weeks of study treatment | 
| Laboratory Measures - Calcium | Calcium blood levels by treatment group and visit. | Once during evaluation and once at the end of 6 weeks of study treatment | 
| Laboratory Measures - Sodium | Sodium blood levels by treatment group and visit. | Once during evaluation and once at the end of 6 weeks of study treatment | 
| Laboratory Measures - Potassium | Potassium blood levels by treatment group and visit. | Once during evaluation and once at the end of 6 weeks of study treatment | 
| Laboratory Measures - Chloride | Chloride blood levels by treatment group and visit. | Once during evaluation and once at the end of 6 weeks of study treatment | 
| Laboratory Measures - CO2 | Carbon Dioxide (CO2) blood levels by treatment group and visit. | Once during evaluation and once at the end of 6 weeks of study treatment | 
| Laboratory Measures - Cholesterol | Total cholesterol blood levels by treatment group and visit. | Once during evaluation and once at the end of 6 weeks of study treatment | 
| Laboratory Measures - HDL | High-density lipoprotein (HDL) blood levels by treatment group and visit. | Once during evaluation and once at the end of 6 weeks of study treatment | 
| Laboratory Measures - LDL | Low-density lipoprotein (LDL) blood levels by treatment group and visit. | Once during evaluation and once at the end of 6 weeks of study treatment | 
| Laboratory Measures - Triglycerides | Triglyceride blood levels by treatment group and visit. | Once during evaluation and once at the end of 6 weeks of study treatment | 
| Laboratory Measures - VLDL | Very low density lipoprotein (VLDL) blood levels by treatment group and visit. | Once during evaluation and once at the end of 6 weeks of study treatment | 
| Laboratory Measures - Glucose | Glucose blood levels by treatment group and visit. | Once during evaluation and once at the end of 6 weeks of study treatment | 
| Laboratory Measures - Albumin | Albumin blood levels by treatment group and visit. | Once during evaluation and once at the end of 6 weeks of study treatment | 
| Laboratory Measures - Globulin | Globulin blood levels by treatment group and visit. | Once during evaluation and once at the end of 6 weeks of study treatment | 
| Laboratory Measures - A/G Ratio | Albumin to Globulin (A/G) ratio in the blood by treatment group and visit. | Once during evaluation and once at the end of 6 weeks of study treatment | 
| Laboratory Measures - Bilirubin | Bilirubin blood level by treatment group and visit. | Once during evaluation and once at the end of 6 weeks of study treatment | 
| Laboratory Measures - Protein | Protein blood level by treatment group and visit. | Once during evaluation and once at the end of 6 weeks of study treatment | 
| Laboratory Measures - BUN | BUN blood level by treatment group and visit. | Once during evaluation and once at the end of 6 weeks of study treatment | 
| Side Effect Checklist (SEC) - Abdominal Pain | Percentage of participants with new onset or worsening compared to baseline of Abdominal Pain rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Anorexia | Percentage of participants with new onset or worsening compared to baseline of Anorexia rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Bruising Easily | Percentage of participants with new onset or worsening compared to baseline of Bruising Easily rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Constipation | Percentage of participants with new onset or worsening compared to baseline of Constipation rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Diarrhea | Percentage of participants with new onset or worsening compared to baseline of Diarrhea rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Dizziness | Percentage of participants with new onset or worsening compared to baseline of Dizziness rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Dry Eye | Percentage of participants with new onset or worsening compared to baseline of Dry Eye rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Dry Mouth | Percentage of participants with new onset or worsening compared to baseline of Dry Mouth rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Enuresis | Percentage of participants with new onset or worsening compared to baseline of Enuresis rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Excessive Tearing of the Eye | Percentage of participants with new onset or worsening compared to baseline of Excessive Tearing of the Eye rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Fever | Percentage of participants with new onset or worsening compared to baseline of Fever rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Headache | Percentage of participants with new onset or worsening compared to baseline of Headache rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Hyperhydrosis | Percentage of participants with new onset or worsening compared to baseline of Hyperhydrosis rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Hypersalivation | Percentage of participants with new onset or worsening compared to baseline of Hypersalivation rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Insomnia | Percentage of participants with new onset or worsening compared to baseline of Insomnia rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Malaise | Percentage of participants with new onset or worsening compared to baseline of Malaise rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Mucosal Ulceration | Percentage of participants with new onset or worsening compared to baseline of Mucosal Ulceration rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Nasal Irritation | Percentage of participants with new onset or worsening compared to baseline of Nasal Irritation rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Nausea | Percentage of participants with new onset or worsening compared to baseline of Nausea rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Rash | Percentage of participants with new onset or worsening compared to baseline of Rash rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Restlessness | Percentage of participants with new onset or worsening compared to baseline of Restlessness rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Sedation | Percentage of participants with new onset or worsening compared to baseline of Sedation rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Sore Throat | Percentage of participants with new onset or worsening compared to baseline of Sore Throat rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Stiffness | Percentage of participants with new onset or worsening compared to baseline of Stiffness rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Tinnitus | Percentage of participants with new onset or worsening compared to baseline of Tinnitus rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Tremor | Percentage of participants with new onset or worsening compared to baseline of Tremor rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Urticaria | Percentage of participants with new onset or worsening compared to baseline of Urticaria rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Uterine Contractions | Percentage of participants with new onset or worsening compared to baseline of Uterine Contractions rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Vomiting | Percentage of participants with new onset or worsening compared to baseline of Vomiting rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Weight Loss | Percentage of participants with new onset or worsening compared to baseline of Weight Loss rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Side Effect Checklist (SEC) - Wheezing | Percentage of participants with new onset or worsening compared to baseline of Wheezing rating on the SEC, by Treatment Group. | Weekly for 6 weeks | 
| Neurocognitive Assessment Battery (MCCB) - Composite Score | MCCB Composite Score by Week ranging from -10-100 with a higher score indicating a better outcome. | Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment). | 
| Neurocognitive Assessment Battery (MCCB) - Attention Vigilance | MCCB Attention Vigilance domain score by week calculated from the Continuous Performance Test, Identical Pairs version. The domain score scale is 20-80, with higher scores indicating a better outcome. . | Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment). | 
| Neurocognitive Assessment Battery (MCCB) - Processing Speed | MCCB Processing Speed domain score by week calculated from the Trail Making Test- Part A, Brief Assessment of Cognition in Schizophrenia- symbol coding subtest, and the Category fluency test- animal naming. The domain score scale is 20-80, with higher scores indicating a better outcome. | Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment). | 
| Neurocognitive Assessment Battery (MCCB) - Reasoning/Problem Solving | MCCB Reasoning/Problem Solving domain score by week calculated from the Neuropsychological Assessment Battery- mazes subtest. The domain score scale is 20-80, with higher scores indicating a better outcome. | Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment). | 
| Neurocognitive Assessment Battery (MCCB) - Social Cognition | MCCB Social Cognition domain score by week calculated from the Mayer-Salovey-Caruso Emotional Intelligence Test- managing emotions branch. The domain score scale is 20-80, with higher scores indicating a better outcome. | Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment). | 
| Neurocognitive Assessment Battery (MCCB) - Verbal Learning | MCCB Verbal Learning domain score by week calculated from the Hopkins Verbal Learning Test-Revised, immediate recall (three learning trials only). The domain score scale is 20-80, with higher scores indicating a better outcome. | Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment). | 
| Neurocognitive Assessment Battery (MCCB) - Visual Learning | MCCB Visual Learning domain score by week calculated from the Brief Visuospatial Memory Test-Revised. The domain score scale is 20-80, with higher scores indicating a better outcome. | Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment). | 
| Neurocognitive Assessment Battery (MCCB) - Working Memory | MCCB Working Memory domain score by week calculated from the Wechsler Memory Scale, 3rd ed., spatial span subtest. The domain score scale is 20-80, with higher scores indicating a better outcome. | Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment). | 
| Positive and Negative Affect Schedule (PANAS) - Negative | Participant reported responses after Brief Role Play rating how they felt during the role plays. Participants rated 12 negative affect items on a scale of 1-5, with 1 being very slightly or not at all and 5 being extremely. The minimum score for this measure is 12 and the maximum score is 60. Higher scores indicate a higher rate of negative affect during the role plays. | Treatment Week 0 and Week 6 | 
| Positive and Negative Affect Schedule (PANAS) - Positive | Participant reported responses after Brief Role Play rating how they felt during the role plays. Participants rated 12 positive affect items on a scale of 1-5, with 1 being very slightly or not at all and 5 being extremely. The minimum score for this measure is 12 and the maximum score is 60. Higher scores indicate a higher rate of positive affect during the role plays. | Treatment Week 0 and Week 6 | 
| Reactions to Partner | Participant reported responses after Brief Role Play. The Reactions to Partner item was calculated by totaling responses to 7 scales. Each scale score ranges from 1-5, which 1 being completely agree and 5 being completely disagree. The minimum score for this measure is 7 and the maximum score is 35. Higher responses indicate a more negative reaction to their role play partner. | Treatment Week 0 and Week 6 | 
| Willingness to Interact | Participant reported responses after Brief Role Play. The Willingness to Interact item calculated by totaling scores from items 1-6. Each score ranges from 1-5, with 1 being definitely willing and 5 being definitely unwilling. The minimum score for this measure is 6 and the maximum score is 30. Lower scores indicate more willingness to interact with their role play partner again in the future. | Treatment Week 0 and Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, oxytocin, galantamine