Clinical trial NCT00116532: Escitalopram for the Treatment of Obsessive Compulsive Disorder (OCD)
Official title: Escitalopram for the Treatment of Obsessive Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obsessive Compulsive Disorder
Keywords: Obsessive Compulsive Disorder
Escitalopram
SSRI
Open Label
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2005-06-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of Escitalopram in the treatment of obsessive compulsive disorder and to determine the optimal treatment dose.

Detailed description: Background and Purpose: Obsessive compulsive disorder affects approximately 3% of the population. Treatment options include the selective serotonin reuptake inhibitors (SSRIs), dual serotonin and norepinephrine reuptake inhibitors, and behavioral therapy. A recent double-blind, placebo-controlled trial demonstrated that citalopram is effective in the treatment of OCD. Escitalopram is a new SSRI that may be more effective than other SSRIs for the treatment of major depression and may have fewer side effects. This study aims to assess the efficacy of escitalopram for the treatment of OCD.

Comparisons: Subject Y-BOCs pre-post treatment. We will also compare the improvement of subjects across the three different medication levels: 10 mg, 20 mg, and 30 mg.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of OCD by DSM-IV
* Age 18-65
* Y-BOCS greater than 20
* Written informed consent
* Females of childbearing potential must have a negative serum or urinary beta-HCG test.

Exclusion Criteria:

* Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception.
* Patients who, in the investigator's judgement, pose a serious suicidal or homicidal risk.
* Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease. Patients on anticoagulant therapy.
* History of seizure disorder
* Comorbid bipolar disorder, psychosis, organic mental disorder, or developmental disorder
* If there is a history of substance abuse, patients in remission at least 6 months.
* Currently being treated with behavioral therapy, specifically exposure and response prevention, for OCD.
* Other medications for medical disorders that may interfere with escitalopram
* Current major depression or prescribed an antidepressant for major depression within the past 12 months.
* Taken an SSRI medication within 2 weeks of beginning the study (4 weeks for fluoxetine).
* More than 1 adequate trial (at least 10 weeks at maximally tolerated dose) with another SSRI in the past.

Primary outcomes:
measure: Y-BOCs scores at 1st and last visit (16 weeks later)
measure: Clinical Global impressions Scale at 2nd visit (2 weeks after 1st visit) and 6th visit (16 weeks post 1st visit)
Secondary outcomes:
measure: HAMD - first and last visit (Given week 0, 2, 4, 8, 12, & 16. Comparisons from week 0 and 16)
measure: BDI - first and last visit (Given week 0, 2, 4, 8, 12, & 16. Comparisons from week 0 and 16)
measure: BAI - first and last visit Given week 0, 2, 4, 8, 12, & 16. Comparisons from week 0 and 16)
measure: QLESQ - first and last visit (week 0 and 16)
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital - OCD Clinic
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Darin D Dougherty, MD
role: PRINCIPAL_INVESTIGATOR
References: