NCT00734435终止2 期
A Proof of Concept, Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled, Study of Zonisamide Sustained Release (SR) 360 mg Versus Placebo in the Prevention of Weight Gain Associated With Olanzapine Therapy for Psychosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 9
- 主要终点
- Percentage change in total body weight
研究概览
简要总结
The purpose of this study is to determine if zonisamide SR will prevent weight gain in schizophrenic subjects who take olanzapine (Zyprexa)
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
- Double (Participant, Investigator)
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
- •Male or female subjects,18-55 years of age
- •Outpatients diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder
- •Body mass index (BMI) between 22-35 kg/m2 (inclusive)
- •Negative serum pregnancy test in women of child-bearing potential
- •If women of child-bearing potential, must be non-lactating and agree to use an acceptable form of contraception, which in all cases, includes one type of barrier method, throughout the study period and for 30 days after discontinuation of study drug
- •Subject requires a change in antipsychotic treatment and olanzapine is deemed by the Investigator to be a reasonable antipsychotic treatment choice
- •No clinically significant abnormality on ECG
- •No clinically significant laboratory abnormality
- •Negative urine drug screen
- •Must be considered reliable and possess a level of understanding that enables the subject to provide written informed consent and to comply with protocol procedures and schedule
- •Must be able to read and understand English
排除标准
- •Diagnosis of substance dependence within the 6 months prior to randomization
- •diagnosis of substance abuse (except for nicotine and caffeine) within the 3 months prior to randomization
- •Suicidal behavior or ideation within 3 months prior to randomization, or any current suicidal ideation or intent
- •Presence of dementia or other organic brain syndrome
- •Serious or unstable medical illnesses
- •Known, uncorrected narrow-angle glaucoma
- •Diagnosis of eating disorder as defined by DSM-IV within 6 months prior to randomization
- •Require treatment with any typical or atypical antipsychotic in addition to olanzapine
研究组 & 干预措施
1
Active Comparator
Zonisamide SR 360 mg and olanzapine 10-20 mg daily
干预措施: zonisamide SR plus olanzapine (Drug)
2
Placebo Comparator
Placebo and olanzapine 10-20 mg daily
干预措施: Placebo plus olanzapine (Drug)
结局指标
主要结局
Percentage change in total body weight
时间窗: Baseline to Week 16
次要结局
未报告次要终点
研究者
研究点 (9)
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