NCT00758966终止2 期
A Proof-of-Concept, Multicenter, Randomized, Double-Blind, Parallel Study of Naltrexone Sustained-Release (SR) and/or Fluoxetine Therapy in the Treatment of Subjects With Obsessive-Compulsive Disorder (OCD)
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
- 8
- 试验地点
- 11
- 主要终点
- Evaluate the mean change from baseline to Week 10 in total Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score between the combination treatment group versus fluoxetine alone and naltrexone SR alone
研究概览
简要总结
The purpose of this study is to determine if the combination of naltrexone SR and fluoxetine is more effective in treating the symptoms of obsessive-compulsive disorder (OCD)than either fluoxetine alone or naltrexone SR alone.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, 18 to 60 years of age (inclusive)
- •Outpatients with a current diagnosis of OCD that have received previous therapy
- •Negative serum pregnancy test as screening in women of child-bearing potential
- •If a woman of child-bearing potential, must agreed to use an acceptable and effective form of contraception
- •No clinically significant abnormality on electrocardiogram (ECG)
- •No clinically significant laboratory abnormality at screening
- •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
排除标准
- •Diagnosis of substance dependence
- •Diagnosis of substance abuse (except for nicotine and caffeine)
- •Serious or unstable medical illnesses
- •Lifetime history of bipolar disorder, schizophrenia or other psychosis, bulimia, anorexia nervosa, Pervasive Developmental Disorder (PDD), Asperger's Syndrome or the presence of antisocial or borderline personality disorder
- •Diagnosis of tic disorder or Tourette's Syndrome
- •Subjects diagnosed with impulse control disorder
- •Known sensitivity or allergic reaction to either naltrexone or fluoxetine
- •Any condition which in the opinion of the investigator or Sponsor makes the subject unsuitable for inclusion in the study
- •Immediate family of investigators, study personnel or Sponsor representatives
研究组 & 干预措施
NF (Naltrexone+Fluoxetine)
Experimental
Naltrexone SR 32 mg and fluoxetine 60 mg
干预措施: Naltrexone 32 mg and fluoxetine 60 mg (Drug)
Fluoxetine
Active Comparator
Fluoxetine 60 mg
干预措施: Fluoxetine 60 mg (Drug)
Naltrexone
Active Comparator
Naltrexone SR 32 mg
干预措施: Naltrexone SR 32 mg (Drug)
结局指标
主要结局
Evaluate the mean change from baseline to Week 10 in total Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score between the combination treatment group versus fluoxetine alone and naltrexone SR alone
时间窗: Baseline to Week 10
次要结局
未报告次要终点
研究者
研究点 (11)
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