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临床试验/NCT01012167
NCT01012167已完成2 期

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

University of Maryland, Baltimore5 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2010年2月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
86
试验地点
5
主要终点
Scale for the Assessment of Negative Symptoms (SANS) Total Score
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 64 Years（Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

3: placebo-galantamine /placebo-oxytocin

Placebo Comparator

Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

干预措施: Placebo-Galantamine (Other)

1: galantamine/placebo-oxytocin

Active Comparator

Subjects randomized to galantamine will receive galantamine and placebo-oxytocin

干预措施: Galantamine (Drug)

1: galantamine/placebo-oxytocin

Active Comparator

Subjects randomized to galantamine will receive galantamine and placebo-oxytocin

干预措施: Placebo-Oxytocin (Other)

2: oxytocin/placebo-galantamine

Active Comparator

Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine

干预措施: Oxytocin (Drug)

2: oxytocin/placebo-galantamine

Active Comparator

Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine

干预措施: Placebo-Galantamine (Other)

3: placebo-galantamine /placebo-oxytocin

Placebo Comparator

Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

干预措施: Placebo-Oxytocin (Other)

结局指标

主要结局

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

时间窗: 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

时间窗: 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.

次要结局

  • Scale for the Assessment of Negative Symptoms (SANS) - Alogia(Every other week for 6 weeks)
  • Scale for the Assessment of Negative Symptoms (SANS) - Blunted Affect(Every other week for 6 weeks)
  • Brief Psychiatric Rating Scale (BPRS) - Total Score(Every other week for 6 weeks)
  • Calgary Depression Scale (CDS) - Total Score(Every other week for 6 weeks)
  • Arizona Sexual Experience Questionnaire (ASEX) Female(Once during evaluation and once at the end of 6 weeks of study treatment)
  • Vital Signs - Diastolic Blood Pressure(Weekly for 6 weeks)
  • Vital Signs - Systolic Blood Pressure(Weekly for 6 weeks)
  • Electrocardiogram (EKG)(Once during Evaluation and once at Treatment Week 6)
  • Barnes Akathisia Scale (BAS) - Global Score(Treatment Week 0 and Week 6)
  • Blood Oxytocin Levels(Treatment Week 0 and Week 6)
  • Side Effect Checklist (SEC) - Bruising Easily(Weekly for 6 weeks)
  • Vital Signs - Weight(Weekly for 6 weeks)
  • Vital Signs - Pulse(Weekly for 6 weeks)
  • Laboratory Measures - Globulin(Once during evaluation and once at the end of 6 weeks of study treatment)
  • Laboratory Measures - A/G Ratio(Once during evaluation and once at the end of 6 weeks of study treatment)
  • Laboratory Measures - Bilirubin(Once during evaluation and once at the end of 6 weeks of study treatment)
  • Laboratory Measures - Protein(Once during evaluation and once at the end of 6 weeks of study treatment)
  • Laboratory Measures - BUN(Once during evaluation and once at the end of 6 weeks of study treatment)
  • Side Effect Checklist (SEC) - Abdominal Pain(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Anorexia(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Constipation(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Diarrhea(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Dizziness(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Dry Eye(Weekly for 6 weeks)
  • Scale for the Assessment of Negative Symptoms (SANS) - Avolition(Every other week for 6 weeks)
  • Scale for the Assessment of Negative Symptoms (SANS) - Anhedonia(Every other week for 6 weeks)
  • Brief Psychiatric Rating Scale (BPRS) - Psychosis Score(Every other week for 6 weeks)
  • Arizona Sexual Experience Questionnaire (ASEX) Male(Once during evaluation and once at the end of 6 weeks of study treatment)
  • Simpson-Angus Scale (SAS)(Baseline, week 3, and week 6)
  • Abnormal Involuntary Movement Scale (AIMS)(Treatment Week 0 and Week 6)
  • Laboratory Measures - Sodium(Once during evaluation and once at the end of 6 weeks of study treatment)
  • Laboratory Measures - Triglycerides(Once during evaluation and once at the end of 6 weeks of study treatment)
  • Laboratory Measures - VLDL(Once during evaluation and once at the end of 6 weeks of study treatment)
  • Laboratory Measures - Glucose(Once during evaluation and once at the end of 6 weeks of study treatment)
  • Laboratory Measures - Albumin(Once during evaluation and once at the end of 6 weeks of study treatment)
  • Laboratory Measures - ALT/SGPT(Once during evaluation and once at the end of 6 weeks of study treatment)
  • Laboratory Measures - Alkaline Phosphatase(Once during evaluation and once at the end of 6 weeks of study treatment)
  • Laboratory Measures - Calcium(Once during evaluation and once at the end of 6 weeks of study treatment)
  • Laboratory Measures - Potassium(Once during evaluation and once at the end of 6 weeks of study treatment)
  • Laboratory Measures - Chloride(Once during evaluation and once at the end of 6 weeks of study treatment)
  • Laboratory Measures - AST/SGOT(Once during evaluation and once at the end of 6 weeks of study treatment)
  • Laboratory Measures - CO2(Once during evaluation and once at the end of 6 weeks of study treatment)
  • Laboratory Measures - Cholesterol(Once during evaluation and once at the end of 6 weeks of study treatment)
  • Laboratory Measures - HDL(Once during evaluation and once at the end of 6 weeks of study treatment)
  • Laboratory Measures - LDL(Once during evaluation and once at the end of 6 weeks of study treatment)
  • Side Effect Checklist (SEC) - Dry Mouth(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Enuresis(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Excessive Tearing of the Eye(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Fever(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Headache(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Hyperhydrosis(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Hypersalivation(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Insomnia(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Malaise(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Mucosal Ulceration(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Nasal Irritation(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Nausea(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Rash(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Restlessness(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Sedation(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Sore Throat(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Stiffness(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Tinnitus(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Tremor(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Urticaria(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Uterine Contractions(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Vomiting(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Weight Loss(Weekly for 6 weeks)
  • Side Effect Checklist (SEC) - Wheezing(Weekly for 6 weeks)
  • Neurocognitive Assessment Battery (MCCB) - Composite Score(Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).)
  • Neurocognitive Assessment Battery (MCCB) - Attention Vigilance(Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).)
  • Neurocognitive Assessment Battery (MCCB) - Processing Speed(Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).)
  • Neurocognitive Assessment Battery (MCCB) - Reasoning/Problem Solving(Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).)
  • Neurocognitive Assessment Battery (MCCB) - Social Cognition(Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).)
  • Neurocognitive Assessment Battery (MCCB) - Verbal Learning(Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).)
  • Neurocognitive Assessment Battery (MCCB) - Visual Learning(Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).)
  • Neurocognitive Assessment Battery (MCCB) - Working Memory(Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).)
  • Positive and Negative Affect Schedule (PANAS) - Negative(Treatment Week 0 and Week 6)
  • Positive and Negative Affect Schedule (PANAS) - Positive(Treatment Week 0 and Week 6)
  • Reactions to Partner(Treatment Week 0 and Week 6)
  • Willingness to Interact(Treatment Week 0 and Week 6)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Buchanan

Chief, Maryland Psychiatric Research Center, Outpatient Research Program

University of Maryland, Baltimore

研究点 (5)

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