Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder

NCT00215137 | Completed Phase 2 Results

• 2 other identifiers: Pro000131505731-04-4R0
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

OCD

Keywords

OCD; SSRI; escitalopram; relapse

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Open Label Escitalopram 10-20 mg/daily

EXPERIMENTAL

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

Randomizationn Placebo 10-20 mg daily

PLACEBO COMPARATOR

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)

Randomization Escitalopram 10-20 mg/daily

ACTIVE COMPARATOR

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

Interventions

escitalopram 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.

Also known as: Lexapro

Open Label Escitalopram 10-20 mg/daily; Randomization Escitalopram 10-20 mg/daily

Placebo ( sugar pill) DRUG

Placebo Comparator in double.blind phase.

Also known as: Placebo

Randomizationn Placebo 10-20 mg daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of OCD
• A minimum score of 16 on the Yale Brown Obsessive-Compulsive Scale (YBOCS) at both the screening and baseline visits

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• Forest Laboratories: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• 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

  RESULT

MeSH Terms

Conditions

Recurrence

Interventions

Escitalopram; Sugars

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Wei Zhang MD
• Organization: Duke University Medical Center Dept of Psychiatry

wei.zhang@duke.edu

919 684 5645

Study Officials

• Wei M. Zhang, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: October 1, 2004
• Primary Completion: January 1, 2009
• Study Completion: March 1, 2009
• Last Updated: July 23, 2014
• Results First Posted: October 29, 2013

Record last verified: 2013-08

Locations

US (1)