Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder - Full Text View

Purpose

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

Condition	Intervention	Phase
OCD	Drug: escitalopram Drug: Placebo ( sugar pill)	Phase 0

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Obsessive-Compulsive Disorder

Drug Information available for: Citalopram hydrobromide Citalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

Change in somatic anxiety [ Time Frame: From screening to week 16 ] [ Designated as safety issue: Yes ]
Symptom ratings that measure obsessive thoughts and compulsive disorders

Enrollment:	12
Study Start Date:	October 2004
Study Completion Date:	March 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Escitalopram 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).	Drug: 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.
Placebo Comparator: Placebo 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).	Drug: Placebo ( sugar pill) Placebo Comparator in double.blind phase.

Arms

Assigned Interventions

Experimental: Escitalopram

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).

Drug: 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.

Placebo Comparator: Placebo

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).

Drug: Placebo ( sugar pill)

Placebo Comparator in double.blind phase.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215137

Locations

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

Forest Laboratories

Investigators

Principal Investigator:

Wei M. Zhang, MD, PhD

Duke University

More Information

No publications provided

Responsible Party:	Duke University
ClinicalTrials.gov Identifier:	NCT00215137 History of Changes
Other Study ID Numbers:	Pro00013150/5731-04-4R0
Study First Received:	September 20, 2005
Last Updated:	December 7, 2012
Health Authority:	United States: Federal Government United States: Food and Drug Administration

Keywords provided by Duke University:

OCD
SSRI
escitalopram
relapse

Additional relevant MeSH terms:

Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on May 21, 2013