NCT00997087终止2 期
Phase IIa A Randomized, Double-Blind, Placebo-Controlled Trial of Flumazenil for the Treatment of Obsessive Compulsive Disorder.
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
- 11
- 试验地点
- 1
- 主要终点
- Yale Brown Obsessive Compulsive Score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of flumazenil in the outpatient treatment of Obsessive Compulsive Disorder (OCD).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and provide written informed consent.
- •Age 19-60, inclusive.
- •Diagnosis documented according to DSM-IV of OCD.
- •Exhibits moderate to severe OCD symptoms and a minimum score of 16 or greater -YBOCS at screening.
- •Willing and able to discontinue current medications taken for the treatment of OCD.
- •Able to attend and participate in all study visits.
- •Agree to continue if in current psychosocial therapy throughout the remainder of the study.
- •If female and of child-bearing potential, willing to use an acceptable method of birth control for the duration of the study.
- •If male, willing to use barrier method of birth control or had previous vasectomy.
排除标准
- •Have other DSM-IV Axis I diagnoses.
- •Pregnant as confirmed by urine analysis, or lactating, or unwilling to comply with use of contraception.
- •Unwilling or unable to washout (discontinue) from prohibited medications such as antidepressants (See Appendix 2).
- •Depression symptoms with a score of 15 or greater on the MADRS at screening.
- •Current suicidal ideation or plan within the last 30 days.
- •Have a medical condition which, in the opinion of the investigator, makes study participation unsafe or noncompliant.
- •Abnormal physical exam or laboratory values which, in the opinion of the investigator, makes study participation unsafe or may require introduction of concomitant medications during the course of the study.
- •Benzodiazepine and/or similar sedative-hypnotic or anxiolytic use or abuse within 15 days of potential flumazenil treatment: patients must not be habituated to benzodiazepines and must provide a urine sample that is negative for benzodiazepines, must not be taking supra-therapeutic doses of zolpidem (AmbienTM) or zaleplon (SonataTM ). (See Appendix 2).
- •Patients who are taking Phenobarbital for a documented seizure disorder can be admitted. Patients with a seizure disorder being managed with clonazepam (KlonopinTM ) or other benzodiazepine cannot participate, patients must not be taking TCA, lithium, methylxanthines, isoniazid, propoxyphene, monoamine oxidase inhibitors, bupropion HCL, and cyclosporine. (See Appendix 2).
- •Previously treated with flumazenil for OCD.
- •AIDS as determined by self-report.
研究组 & 干预措施
Sugar Pill, Placebo
Placebo Comparator
干预措施: Flumazenil (Drug)
Flumazenil
Active Comparator
干预措施: Flumazenil (Drug)
结局指标
主要结局
Yale Brown Obsessive Compulsive Score
时间窗: 12 weeks
次要结局
- Safety will be assessed by Adverse Events, Changes in physical exam, laboratory values.(12 weeks)
研究者
James G.Sullivan, MD
Principal Investigator
Parkway Medical Center
研究点 (1)
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