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Completed

NCT Number: NCT01012167

Oxytocin or Galantamine Versus 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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Baltimore VA Medical Center, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxytocin

Drug

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

Galantamine

Drug

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

Placebo-Oxytocin

Other

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

Placebo-Galantamine

Other

Placebo tablets twice a day for 6 weeks

Primary outcomes

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

    Time frame: Every other week for 6 weeks

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

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

    Time frame: Treatment Week 0 and Week 6

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

Secondary outcomes

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

    Time frame: Every other week for 6 weeks

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

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

    Time frame: Every other week for 6 weeks

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

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

    Time frame: Every other week for 6 weeks

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

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

    Time frame: Every other week for 6 weeks

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

  5. Brief Psychiatric Rating Scale (BPRS) - Total Score

    Time frame: Every other week for 6 weeks

    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.

  6. Brief Psychiatric Rating Scale (BPRS) - Psychosis Score

    Time frame: Every other week for 6 weeks

    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.

  7. Calgary Depression Scale (CDS) - Total Score

    Time frame: Every other week for 6 weeks

    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.

  8. Arizona Sexual Experience Questionnaire (ASEX) Female

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

    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.

  9. Arizona Sexual Experience Questionnaire (ASEX) Male

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

    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.

  10. Vital Signs - Diastolic Blood Pressure

    Time frame: Weekly for 6 weeks

    Mean diastolic blood pressure by treatment and follow-up week

  11. Vital Signs - Systolic Blood Pressure

    Time frame: Weekly for 6 weeks

    Mean systolic blood pressure by treatment and follow-up week

  12. Vital Signs - Weight

    Time frame: Weekly for 6 weeks

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

  13. Vital Signs - Pulse

    Time frame: Weekly for 6 weeks

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

  14. Simpson-Angus Scale (SAS)

    Time frame: Baseline, week 3, and week 6

    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.

  15. Abnormal Involuntary Movement Scale (AIMS)

    Time frame: Treatment Week 0 and Week 6

    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.

  16. Electrocardiogram (EKG)

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

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

  17. Barnes Akathisia Scale (BAS) - Global Score

    Time frame: Treatment Week 0 and Week 6

    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.

  18. Blood Oxytocin Levels

    Time frame: Treatment Week 0 and Week 6

    Blood Oxytocin Levels by Treatment and Visit

  19. Laboratory Measures - ALT/SGPT

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

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

  20. Laboratory Measures - AST/SGOT

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

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

  21. Laboratory Measures - Alkaline Phosphatase

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

    Alkaline phosphatase blood level by treatment group and visit.

  22. Laboratory Measures - Calcium

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

    Calcium blood levels by treatment group and visit.

  23. Laboratory Measures - Sodium

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

    Sodium blood levels by treatment group and visit.

  24. Laboratory Measures - Potassium

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

    Potassium blood levels by treatment group and visit.

  25. Laboratory Measures - Chloride

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

    Chloride blood levels by treatment group and visit.

  26. Laboratory Measures - CO2

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

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

  27. Laboratory Measures - Cholesterol

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

    Total cholesterol blood levels by treatment group and visit.

  28. Laboratory Measures - HDL

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

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

  29. Laboratory Measures - LDL

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

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

  30. Laboratory Measures - Triglycerides

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

    Triglyceride blood levels by treatment group and visit.

  31. Laboratory Measures - VLDL

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

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

  32. Laboratory Measures - Glucose

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

    Glucose blood levels by treatment group and visit.

  33. Laboratory Measures - Albumin

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

    Albumin blood levels by treatment group and visit.

  34. Laboratory Measures - Globulin

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

    Globulin blood levels by treatment group and visit.

  35. Laboratory Measures - A/G Ratio

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

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

  36. Laboratory Measures - Bilirubin

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

    Bilirubin blood level by treatment group and visit.

  37. Laboratory Measures - Protein

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

    Protein blood level by treatment group and visit.

  38. Laboratory Measures - BUN

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

    BUN blood level by treatment group and visit.

  39. Side Effect Checklist (SEC) - Abdominal Pain

    Time frame: Weekly for 6 weeks

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

  40. Side Effect Checklist (SEC) - Anorexia

    Time frame: Weekly for 6 weeks

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

  41. Side Effect Checklist (SEC) - Bruising Easily

    Time frame: Weekly for 6 weeks

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

  42. Side Effect Checklist (SEC) - Constipation

    Time frame: Weekly for 6 weeks

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

  43. Side Effect Checklist (SEC) - Diarrhea

    Time frame: Weekly for 6 weeks

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

  44. Side Effect Checklist (SEC) - Dizziness

    Time frame: Weekly for 6 weeks

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

  45. Side Effect Checklist (SEC) - Dry Eye

    Time frame: Weekly for 6 weeks

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

  46. Side Effect Checklist (SEC) - Dry Mouth

    Time frame: Weekly for 6 weeks

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

  47. Side Effect Checklist (SEC) - Enuresis

    Time frame: Weekly for 6 weeks

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

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

    Time frame: Weekly for 6 weeks

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

  49. Side Effect Checklist (SEC) - Fever

    Time frame: Weekly for 6 weeks

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

  50. Side Effect Checklist (SEC) - Headache

    Time frame: Weekly for 6 weeks

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

  51. Side Effect Checklist (SEC) - Hyperhydrosis

    Time frame: Weekly for 6 weeks

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

  52. Side Effect Checklist (SEC) - Hypersalivation

    Time frame: Weekly for 6 weeks

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

  53. Side Effect Checklist (SEC) - Insomnia

    Time frame: Weekly for 6 weeks

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

  54. Side Effect Checklist (SEC) - Malaise

    Time frame: Weekly for 6 weeks

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

  55. Side Effect Checklist (SEC) - Mucosal Ulceration

    Time frame: Weekly for 6 weeks

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

  56. Side Effect Checklist (SEC) - Nasal Irritation

    Time frame: Weekly for 6 weeks

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

  57. Side Effect Checklist (SEC) - Nausea

    Time frame: Weekly for 6 weeks

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

  58. Side Effect Checklist (SEC) - Rash

    Time frame: Weekly for 6 weeks

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

  59. Side Effect Checklist (SEC) - Restlessness

    Time frame: Weekly for 6 weeks

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

  60. Side Effect Checklist (SEC) - Sedation

    Time frame: Weekly for 6 weeks

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

  61. Side Effect Checklist (SEC) - Sore Throat

    Time frame: Weekly for 6 weeks

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

  62. Side Effect Checklist (SEC) - Stiffness

    Time frame: Weekly for 6 weeks

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

  63. Side Effect Checklist (SEC) - Tinnitus

    Time frame: Weekly for 6 weeks

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

  64. Side Effect Checklist (SEC) - Tremor

    Time frame: Weekly for 6 weeks

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

  65. Side Effect Checklist (SEC) - Urticaria

    Time frame: Weekly for 6 weeks

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

  66. Side Effect Checklist (SEC) - Uterine Contractions

    Time frame: Weekly for 6 weeks

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

  67. Side Effect Checklist (SEC) - Vomiting

    Time frame: Weekly for 6 weeks

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

  68. Side Effect Checklist (SEC) - Weight Loss

    Time frame: Weekly for 6 weeks

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

  69. Side Effect Checklist (SEC) - Wheezing

    Time frame: Weekly for 6 weeks

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

  70. Neurocognitive Assessment Battery (MCCB) - Composite Score

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

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

  71. Neurocognitive Assessment Battery (MCCB) - Attention Vigilance

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

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

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  72. Neurocognitive Assessment Battery (MCCB) - Processing Speed

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

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

  73. Neurocognitive Assessment Battery (MCCB) - Reasoning/Problem Solving

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

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

  74. Neurocognitive Assessment Battery (MCCB) - Social Cognition

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

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

  75. Neurocognitive Assessment Battery (MCCB) - Verbal Learning

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

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

  76. Neurocognitive Assessment Battery (MCCB) - Visual Learning

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

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

  77. Neurocognitive Assessment Battery (MCCB) - Working Memory

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

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

  78. Positive and Negative Affect Schedule (PANAS) - Negative

    Time frame: Treatment Week 0 and Week 6

    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.

  79. Positive and Negative Affect Schedule (PANAS) - Positive

    Time frame: Treatment Week 0 and Week 6

    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.

  80. Reactions to Partner

    Time frame: Treatment Week 0 and Week 6

    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.

  81. Willingness to Interact

    Time frame: Treatment Week 0 and Week 6

    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.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: CIDAR-3

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Nov 11, 2009
Registry last updated
Jan 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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