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

Study Description

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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 Design

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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

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Stengler-Wenzke K, Müller 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00305500 History of Changes
Other Study ID Numbers:	EscitaHD001
First Posted:	March 22, 2006
Last Update Posted:	July 26, 2006
Last Verified:	March 2006

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; Citalopram; Dexetimide; 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; Antiparkinson Agents; Anti-Dyskinesia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents