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Tolerability and Efficacy of High Dose Escitalopram for the Treatment of Obsessive-Compulsive Disorder (OCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00305500
Recruitment Status : Completed
First Posted : March 22, 2006
Last Update Posted : July 26, 2006
Information provided by:
Abarbanel Mental Health Center

Brief Summary:

Objectives: To evaluate tolerability and efficacy of escitalopram treatment in high dose than 20-50 mg/d in out-patients with OCD Type of the study: Open label, prospective study.

Number of patients: 100 patients with OCD

Duration of the study: 18-weeks of active treatment, 8-visits:

Dose titration:

One week of 10mg Four weeks of 20mg After 4 weeks of 20mg treatment- if partial/no response, according to YBOCS score and clinical judgment, dose increase of up to 50mg depending on response, adverse events, patient preference and judgment of the clinician 12 weeks follow up on high dose. Total of 18 weeks of follow-up.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Drug: escitalopram Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Open Study of High Dose Escitalopram for the Treatment of Obsessive-Compulsive Disorder in Adults
Study Start Date : March 2006
Study Completion Date : December 2006

Primary Outcome Measures :
  1. Safety as recorded by adverse-events and side-effects reports.

Secondary Outcome Measures :
  1. Reduction in YBOCS scores at week 18

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Men and women over 18 years of age
  2. DSM IV-TR criteria for OCD
  3. OCD associated with most distress or most interference in the patient's life as judged by the treating physician
  4. Yale-Brown Obsessive Compulsive Scale (YBOCS) total score ≥ 16

Exclusion Criteria:

  1. Other primary or co-primary psychiatric disorder which is more distressful for the patient then the OCD, as evaluated by investigator
  2. Patients with any history of mania/bipolar disorder
  3. Patients using medications which are contraindicated with the use of escitalopram
  4. Known contraindication for the use of citalopram or escitalopram.
  5. Unable to understand and give informed consent
  6. Prominent suicidal ideation (2 points or more in the MADRS "suicidal thoughts" item)
  7. Alcohol or substance dependence in the past 6 months
  8. Major physical illness
  9. Woman currently pregnant or less then 4 weeks after a childbirth, a woman lactating, or a woman of childbearing potential not using a medically accepted form of contraception.
  10. Liver function abnormality
  11. EKG abnormalities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00305500

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Abarbanel MHC
Bat-Yam, Israel, 59100
Sponsors and Collaborators
Abarbanel Mental Health Center
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Study Director: Yoram Barak, MD, MHA Abarbanel MHC
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00305500    
Other Study ID Numbers: EscitaHD001
First Posted: March 22, 2006    Key Record Dates
Last Update Posted: July 26, 2006
Last Verified: March 2006
Keywords provided by Abarbanel Mental Health Center:
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs