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Completed

NCT Number: NCT00116532

Escitalopram for the Treatment of Obsessive Compulsive Disorder (OCD)

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital - OCD Clinic

Charlestown, Massachusetts, 02129, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Escitalopram

Drug

Primary outcomes

  1. Y-BOCs scores at 1st and last visit (16 weeks later)

  2. Clinical Global impressions Scale at 2nd visit (2 weeks after 1st visit) and 6th visit (16 weeks post 1st visit)

Secondary outcomes

  1. HAMD - first and last visit (Given week 0, 2, 4, 8, 12, & 16. Comparisons from week 0 and 16)

  2. BDI - first and last visit (Given week 0, 2, 4, 8, 12, & 16. Comparisons from week 0 and 16)

  3. BAI - first and last visit Given week 0, 2, 4, 8, 12, & 16. Comparisons from week 0 and 16)

  4. QLESQ - first and last visit (week 0 and 16)

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Forest Laboratories

Registry information

Official study title

Escitalopram for the Treatment of Obsessive Compulsive Disorder

Important dates

Study start
2002
Study completion
2007
First posted
Jun 30, 2005
Registry last updated
Apr 24, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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