Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder

NCT ID: NCT00215137

Last Updated: 2014-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2009-03-31

Brief Summary

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

Detailed Description

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.

Conditions

OCD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

escitalopram

Intervention Type: DRUG

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.

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).

Group Type: PLACEBO_COMPARATOR

Placebo ( sugar pill)

Intervention Type: DRUG

Placebo Comparator in double.blind phase.

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).

Group Type: ACTIVE_COMPARATOR

escitalopram

Intervention Type: DRUG

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.

Interventions

escitalopram

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.

Intervention Type: DRUG

Placebo ( sugar pill)

Placebo Comparator in double.blind phase.

Intervention Type: DRUG

Other Intervention Names

Lexapro; Placebo

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Forest Laboratories

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei M. Zhang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

C. Joseph Wang, M.D., Ph.D.; Jonathan R. Davidson, M.D.; Kathryn M. Connor, M.D.;Weihui Li1, M.D.,Ph.D. and Wei Zhang, M.D., Ph.D. Unpublished Manuscript

Reference Type: RESULT

Other Identifiers

5731-04-4R0

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00013150

Identifier Type: -

Identifier Source: org_study_id