Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00215137
First received: September 20, 2005
Last updated: July 14, 2014
Last verified: August 2013
  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 2

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:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Yale Brown Obsessive Compulsive Scale [ Time Frame: Open Label Phase Baseline,Randomization Phase Baseline or Beginning ] [ Designated as safety issue: No ]
    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.


Enrollment: 14
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: 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.
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.
Other Name: Lexapro
Placebo Comparator: 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).
Drug: Placebo ( sugar pill)
Placebo Comparator in double.blind phase.
Other Name: Placebo
Active Comparator: 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).
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.
Other Name: Lexapro

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: April 15, 2013
Last Updated: July 14, 2014
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:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety 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
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 22, 2014