Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder
Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: OCD
Intervention: escitalopram (Drug); Placebo ( sugar pill) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Duke University Official(s) and/or principal investigator(s):
Wei M. Zhang, MD, PhD, Principal Investigator, Affiliation: Duke University
Summary
This study will determine the safety and effectiveness of escitalopram (Lexapro)in treating
obsessive-compulsive disorder (OCD) symptoms.
Clinical Details
Official title: Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Yale Brown Obsessive Compulsive Scale
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Duke University Medical Center, Durham, North Carolina 27710, United States
Additional Information
Starting date: October 2004
Last updated: July 14, 2014
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