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

This study has been completed.
Sponsor:
Information provided by:
Abarbanel Mental Health Center
ClinicalTrials.gov Identifier:
NCT00305500
First received: March 21, 2006
Last updated: July 25, 2006
Last verified: March 2006
  Purpose

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 Intervention Phase
Obsessive-Compulsive Disorder
Drug: escitalopram
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Open Study of High Dose Escitalopram for the Treatment of Obsessive-Compulsive Disorder in Adults

Resource links provided by NLM:


Further study details as provided by Abarbanel Mental Health Center:

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

Secondary Outcome Measures:
  • Reduction in YBOCS scores at week 18

Estimated Enrollment: 100
Study Start Date: March 2006
Estimated Study Completion Date: December 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305500

Locations
Israel
Abarbanel MHC
Bat-Yam, Israel, 59100
Sponsors and Collaborators
Abarbanel Mental Health Center
Investigators
Study Director: Yoram Barak, MD, MHA Abarbanel MHC
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00305500     History of Changes
Other Study ID Numbers: EscitaHD001
Study First Received: March 21, 2006
Last Updated: July 25, 2006
Health Authority: Israel: Ministry of Health

Keywords provided by Abarbanel Mental Health Center:
OCD
Escitalopram

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 18, 2014