Oxytocin or Galantamine Versus Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia (CIDAR-3)

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

The project is designed to address the following two primary aims:

1. To determine whether adjunctive oxytocin is superior to placebo for the treatment of persistent negative symptoms, as measured by the SANS total score, in people with schizophrenia.
2. To determine whether adjunctive Galantamine is superior to placebo for the treatment of cognitive impairments, as measured by improvement on a composite neurocognitive score in people with schizophrenia.

The investigators will also address the following secondary aims:

1. To determine whether people with schizophrenia treated with adjunctive oxytocin, compared to placebo, will show greater improvement on markers of negative symptom liability including: social affiliation, facial affect recognition, olfactory discrimination, initiation of smooth pursuit and latency of internally-driven saccades.
2. To determine whether people with schizophrenia treated with adjunctive Galantamine, compared to placebo, will show greater improvement on markers of cognitive impairment liability including: predictive pursuit, P50 sensory gating and visual-spatial working memory.

The investigators will address the following exploratory aims:

1. To determine whether changes in markers of negative symptom liability are correlated with changes in SANS total score.
2. To determine whether changes in markers of cognitive impairment liability are correlated with changes in the composite neurocognitive score.
3. To determine the response to oxytocin of all cognition domains assessed by the MATRICS battery, and to determine the response to Galantamine of all cognition domains assessed by the MATRICS, which are not included in the primary neurocognitive outcome score.
4. To determine whether there is a differential response of oxytocin and Galantamine on the SANS total score, composite neurocognitive score, and with the phenotypic measures of negative symptom and cognitive impairment liability.

5. To determine whether oxytocin and Galantamine are associated with:

   • adverse effects on positive or depressive symptoms;
   • adverse effects on motor symptoms;
   • adverse effects on laboratory and EKG measures;
   • increased occurrence of side effects;
   • social interest that is independent of sexual desire.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Galantamine; Other: Placebo-Oxytocin; Drug: Oxytocin; Other: Placebo-Galantamine

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21228
      • Maryland Psychiatric Research Center
    • Baltimore, Maryland, United States, 21201
      • Baltimore VA Medical Center
    • Baltimore, Maryland, United States, 21201
      • Community Mental Health Centers
    • Baltimore, Maryland, United States, 21222
      • Keypoint Community Mental Health Centers
    • Catonsville, Maryland, United States, 21228
      • Maryland Psychiatric Research Center
    • Dundalk, Maryland, United States, 21222
      • Keypoint Mental health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1: galantamine/placebo-oxytocin; Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Drug: Galantamine; 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; Other: Placebo-Oxytocin; Saline nasal spray with a total of 6 puffs of the spray, 3 in each nostril at each administration
Active Comparator: 2: oxytocin/placebo-galantamine; Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Drug: Oxytocin; 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; Other: Placebo-Galantamine; Placebo tablets twice a day for 6 weeks
Placebo Comparator: 3: placebo-galantamine /placebo-oxytocin; Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin	Other: Placebo-Oxytocin; Saline nasal spray with a total of 6 puffs of the spray, 3 in each nostril at each administration; Other: Placebo-Galantamine; Placebo tablets twice a day for 6 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: William T Carpenter, M.D., Maryland Psychiatric Research Center

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: April 28, 2009
• First Submitted That Met QC Criteria: November 5, 2009
• First Posted (Estimate): November 11, 2009

Study Record Updates

• Last Update Posted (Actual): January 12, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Schizophrenia, oxytocin, galantamine
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Cognition Disorders; Schizophrenia; Cognitive Dysfunction; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Reproductive Control Agents; Nootropic Agents; Oxytocics; Cholinesterase Inhibitors; Parasympathomimetics; Oxytocin; Galantamine
• Other Study ID Numbers: HP-00044324; 1P50MH082999-01 (U.S. NIH Grant/Contract)