ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 40 of 64 for:    dry mouth | NIH

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01012167
Recruitment Status : Completed
First Posted : November 11, 2009
Results First Posted : June 2, 2017
Last Update Posted : June 2, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
William Carpenter, University of Maryland

April 28, 2009
November 11, 2009
May 25, 2016
June 2, 2017
June 2, 2017
February 2010
July 2014   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
  • Scale for the Assessment of Negative Symptoms (SANS) Total Score [ Time Frame: Weekly for 6 weeks ]
  • Neurocognitive assessment battery composite score [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]
Complete list of historical versions of study NCT01012167 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Vital Signs - Diastolic Blood Pressure [ Time Frame: Weekly for 6 weeks ]
    Mean diastolic blood pressure by treatment and follow-up week
  • Vital Signs - Systolic Blood Pressure [ Time Frame: Weekly for 6 weeks ]
    Mean systolic blood pressure by treatment and follow-up week
  • Vital Signs - Weight [ Time Frame: Weekly for 6 weeks ]
    Mean weight (kg) by treatment and follow-up week
  • Vital Signs - Pulse [ Time Frame: Weekly for 6 weeks ]
    Mean sitting pulse (bpm) by treatment and follow-up week
  • 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.
  • 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.
  • Electrocardiogram (EKG) [ Time Frame: Once during Evaluation and once at Treatment Week 6 ]
    Mean corrected QT interval (QTc) by study week and treatment.
  • 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.
  • Blood Oxytocin Levels [ Time Frame: Treatment Week 0 and Week 6 ]
    Blood Oxytocin Levels by Treatment and Visit
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • P-50 Testing [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]
  • Eye Tracking measures [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]
  • Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Weekly for 6 weeks ]
  • Calgary Depression Scale (CDS) [ Time Frame: Weekly for 6 weeks ]
  • Clinical Global Impressions (CGI) [ Time Frame: Weekly for 6 weeks ]
  • Arizona Sexual Experience Questionnaire ASEX [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]
  • Likert-type Scale for Social Engagement [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]
  • Simpson-Angus Scale (SAS) [ Time Frame: Baseline, week 3, and week 6 ]
  • MPRC-TD scale [ Time Frame: Baseline, week 3, and week 6 ]
  • Barnes Akathisia Scale (BAS) [ Time Frame: Baseline, week 3, and week 6 ]
  • Fagerstrom Test of Nicotine Dependence (FTND) [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]
  • Side Effect Checklist (SEC) [ Time Frame: Weekly for 6 weeks ]
  • Vital Signs [ Time Frame: Weekly for 6 weeks ]
  • EKG [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]
  • Laboratory measures [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]
Not Provided
Not Provided
 
Oxytocin or Galantamine Versus Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • 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
  • 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
  • Other: Placebo-Galantamine
    Placebo tablets twice a day for 6 weeks
  • Active Comparator: 1: galantamine/placebo-oxytocin
    Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
    Interventions:
    • Drug: Galantamine
    • Other: Placebo-Oxytocin
  • Active Comparator: 2: oxytocin/placebo-galantamine
    Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
    Interventions:
    • Drug: Oxytocin
    • Other: Placebo-Galantamine
  • Placebo Comparator: 3: placebo-galantamine /placebo-oxytocin
    Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
    Interventions:
    • Other: Placebo-Oxytocin
    • Other: Placebo-Galantamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
140
July 2014
July 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01012167
HP-00044324
1P50MH082999-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
William Carpenter, University of Maryland
University of Maryland
National Institute of Mental Health (NIMH)
Principal Investigator: William T Carpenter, M.D. University of Maryland
University of Maryland
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP