DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017