Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder

Study Overview
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Brief Summary
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This study will determine the safety and effectiveness of escitalopram (Lexapro)in treating obsessive-compulsive disorder (OCD) symptoms.

Detailed Description
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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.

Official Title
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Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder

Conditions
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OCD

Intervention / Treatment
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* Drug: escitalopram
* Drug: Placebo ( sugar pill)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of OCD A minimum score of 16 on the Yale Brown Obsessive-Compulsive Scale (YBOCS) at both the screening and baseline visits Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label Escitalopram 10-20 mg/daily<br>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. | Drug: escitalopram<br>* Open label Treatment: Escitalopram 10 mg/day for 1 week and then 20 mg /day for 7 weeks. Double Blind Treatment: Escitalopram 20 mg/day.<br>* Other names: Lexapro;|
| Placebo Comparator: Randomizationn Placebo 10-20 mg daily<br>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). | Drug: Placebo ( sugar pill)<br>* Placebo Comparator in double.blind phase.<br>* Other names: Placebo;|
| Active Comparator: Randomization Escitalopram 10-20 mg/daily<br>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). | Drug: escitalopram<br>* Open label Treatment: Escitalopram 10 mg/day for 1 week and then 20 mg /day for 7 weeks. Double Blind Treatment: Escitalopram 20 mg/day.<br>* Other names: Lexapro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale Brown Obsessive Compulsive Scale | 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. | Open Label Phase Baseline,Randomization Phase Baseline or Beginning | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCD, SSRI, escitalopram, relapse