NCT00743847撤回2 期
A Phase 2 6-Week, Double-Blind, Placebo-Controlled, Multicenter Trial Of Varenicline Tartrate (CP-526,555) For Cognitive Impairment In Subjects With Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- CNS Vital Signs Cognition Battery (CNS-VS-M) normed composite score
研究概览
简要总结
The primary objective of this protocol is to assess the efficacy of two dose strengths of varenicline (0.5 mg BID and 1mg BID) as adjunctive treatment for cognitive impairment in symptomatically stable outpatient schizophrenic subjects who are receiving treatment with atypical antipsychotic medications.
A secondary objective is to evaluate the safety and tolerability of two doses of varenicline in symptomatically stable schizophrenic subjects who are receiving treatment with atypical antipsychotic medications.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a current diagnosis of schizophrenia
- •Subjects must be on ongoing maintenance antipsychotic monotherapy or combination therapy with risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, or paliperidone.
- •Evidence of stable symptomatology ≥3 months (eg, no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of symptoms of schizophrenia).
排除标准
- •Subjects with a current DSM-IV axis I diagnosis other than schizophrenia.
- •Current treatment with conventional antipsychotics (e.g. fluphenazine, haloperidol) or clozapine, or the use of adjunctive anticholinergic treatment.
研究组 & 干预措施
placebo
Placebo Comparator
干预措施: placebo (Drug)
varenicline 0.5 mg BID
Active Comparator
干预措施: varenicline (Drug)
varenicline 1mg BID
Active Comparator
干预措施: varenicline (Drug)
结局指标
主要结局
CNS Vital Signs Cognition Battery (CNS-VS-M) normed composite score
时间窗: screening, wk -1, baseline, wk 1,3,6
次要结局
- CNS-VS-M un-normed composite score(screening, wk-1,baseline,wk1,3,6)
- CNS-VS-M un-normed and normed domain scores(screening, wk-1,baseline, wk1,3,6)
- University of California San Diego Performance Skills Assessment Brief (UPSA-B) total score(baseline, wk 1,3,6)
- Severity Item for Cognitive Impairment-Clinician and Patient Versions (SICI-CV; SICI-PV)(baseline, wk6)
- Global Improvement in Cognition Clinician and Patient Versions (GIC-CV;GIC-PV)(wk 1,3,6)
- Safety assessments, including adverse events, electrocardiographic assessments, neuropsychiatric assessments (performed weekly), physical exam, and laboratory measures(weekly)
研究者
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