Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

escitalopram

Placebo ( sugar pill)

About this trial

This is an interventional treatment trial for OCD focused on measuring OCD, SSRI, escitalopram, relapse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Open Label Escitalopram 10-20 mg/daily

Randomizationn Placebo 10-20 mg daily

Randomization Escitalopram 10-20 mg/daily

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00215137

First Posted

September 20, 2005

Last Updated

July 14, 2014

Sponsor

Duke University

Collaborators

Forest Laboratories

1. Study Identification

Unique Protocol Identification Number

NCT00215137

Brief Title

Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder

Official Title

Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

October 2004 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

Forest Laboratories

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

OCD

Keywords

OCD, SSRI, escitalopram, relapse

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Open Label Escitalopram 10-20 mg/daily

Arm Type

Experimental

Arm Description

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.

Arm Title

Randomizationn Placebo 10-20 mg daily

Arm Type

Placebo Comparator

Arm Description

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).

Arm Title

Randomization Escitalopram 10-20 mg/daily

Arm Type

Active Comparator

Arm Description

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).

Intervention Type

Drug

Intervention Name(s)

escitalopram

Other Intervention Name(s)

Lexapro

Intervention Description

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

Intervention Name(s)

Placebo ( sugar pill)

Other Intervention Name(s)

Placebo

Intervention Description

Placebo Comparator in double.blind phase.

Primary Outcome Measure Information:

Title

Yale Brown Obsessive Compulsive Scale

Description

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.

Time Frame

Open Label Phase Baseline,Randomization Phase Baseline or Beginning

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei M. Zhang, MD, PhD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Citations:

Citation

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

Results Reference

result

OCD

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial