Phase 2
N=14
Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder
OCD
Bottom Line
View on ClinicalTrials.gov: NCT00215137 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcome: Primary: Yale Brown Obsessive Compulsive Scale — 24.79; 12.71; 16.00; 15.36 units on a scale — p=0.0002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- escitalopram (Drug); Placebo ( sugar pill) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Yale Brown Obsessive Compulsive Scale |
24.79; 12.71; 16.00; 15.36; 20.17; 15.8 | 0.0002 sig |
Summary
This study will determine the safety and effectiveness of escitalopram (Lexapro)in treating obsessive-compulsive disorder (OCD) symptoms.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00215137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.