Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Yale Brown Obsessive Compulsive Scale
研究概览
简要总结
This study will determine the safety and effectiveness of escitalopram (Lexapro)in treating obsessive-compulsive disorder (OCD) symptoms.
详细描述
OCD is a chronic and disabling disorder for which Selective Serotonin Reuptake Inhibitor(SSRI) drugs can be effective. The purpose of this study is to evaluate the effects of an SSRI, escitalopram, in OCD patients.
This study will last 16 weeks and will comprise 2 phases. Phase 1 is an open label in which all participants will receive daily escitalopram for 8 weeks. Those who have responded to treatment at the end of the 8 weeks will be randomly assigned to either continue or discontinue their treatment for an additional 8 weeks. Those who do not respond to treatment at the end of Phase 1 will discontinue the study and be offered three free visits with a study clinician or referred elsewhere for treatment, based on the their preference. Study visits are made at baseline, and at Weeks 1, 2, 4, and 8 in Phase 1 and Weeks 12 and 16 in Phase 2.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of OCD
- •A minimum score of 16 on the Yale Brown Obsessive-Compulsive Scale (YBOCS) at both the screening and baseline visits
排除标准
- •Lifetime history of psychosis or cognitive dysfunction due to a general medical condition or substance use
- •A primary diagnosis of another Axis I psychiatric disorder
- •Alcohol or other substance abuse or dependence within the last 6 months
- •Unstable medical condition
- •Clinically significant laboratory abnormality
- •Failure of a previous 10-week trial of citalopram of at least 40 mg/day or escitalopram 20 mg/day
- •Active suicidality
- •History of violent behavior in the past year or current risk of serious violence
- •A history of sensitivity to citalopram or escitalopram
- •Use of other investigational drugs within 30 days of baseline or other psychotropic drugs or herbs within 14 days of baseline (28 days for fluoxetine)
- •Need for concurrent psychotherapeutic intervention
- •Pregnant or lactating females.
研究组 & 干预措施
Open Label Escitalopram 10-20 mg/daily
Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.
干预措施: escitalopram (Drug)
Randomizationn Placebo 10-20 mg daily
Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
干预措施: Placebo ( sugar pill) (Drug)
Randomization Escitalopram 10-20 mg/daily
Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
干预措施: escitalopram (Drug)
结局指标
主要结局
Yale Brown Obsessive Compulsive Scale
时间窗: Open Label Phase Baseline,Randomization Phase Baseline or Beginning
The Yale Brown Obsessive Compulsive Scale (YBOCS) is a clinician administered measure of the severity of obsessive compulsive disorder(OCD). Higher scores indicate a greater severity of OCD symptoms. The score can range from a minimum of zero to a maximum of forty.
次要结局
未报告次要终点