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

Sponsor:	Abarbanel Mental Health Center
Information provided by:	Abarbanel Mental Health Center
ClinicalTrials.gov Identifier:	NCT00305500

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 III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase III Open Study of High Dose Escitalopram for the Treatment of Obsessive-Compulsive Disorder in Adults

Resource links provided by NLM:

MedlinePlus related topics: Obsessive-Compulsive Disorder

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

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:

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

Exclusion Criteria:

Other primary or co-primary psychiatric disorder which is more distressful for the patient then the OCD, as evaluated by investigator
Patients with any history of mania/bipolar disorder
Patients using medications which are contraindicated with the use of escitalopram
Known contraindication for the use of citalopram or escitalopram.
Unable to understand and give informed consent
Prominent suicidal ideation (2 points or more in the MADRS “suicidal thoughts” item)
Alcohol or substance dependence in the past 6 months
Major physical illness
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.
Liver function abnormality
EKG abnormalities

Contacts and Locations

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:

Stengler-Wenzke K, Muller U, Barthel H, Angermeyer MC, Sabri O, Hesse S. Serotonin transporter imaging with [123I]beta-CIT SPECT before and after one year of citalopram treatment of obsessive-compulsive disorder. Neuropsychobiology. 2006;53(1):40-5. Epub 2006 Jan 4.

Fontenelle LF, Mendlowicz MV, Miguel EC, Versiani M. Citalopram plus reboxetine in treatment-resistant obsessive-compulsive disorder. World J Biol Psychiatry. 2005;6(1):57-9.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Rabinowitz I, Baruch Y, Barak Y. High-dose escitalopram for the treatment of obsessive-compulsive disorder. Int Clin Psychopharmacol. 2008 Jan;23(1):49-53.

Study ID Numbers:	EscitaHD001
Study First Received:	March 21, 2006
Last Updated:	July 25, 2006
ClinicalTrials.gov Identifier:	NCT00305500 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Abarbanel Mental Health Center:

OCD
Escitalopram

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Pathologic Processes
Mental Disorders
Therapeutic Uses
Dexetimide

Antidepressive Agents, Second-Generation
Obsessive-Compulsive Disorder
Antidepressive Agents
Disease
Citalopram
Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Anxiety Disorders
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009