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

NCT00305500 | Completed Phase 3

• 1 other identifier: EscitaHD001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

OCD; Escitalopram

Outcome Measures

Primary Outcomes (1)

• Safety as recorded by adverse-events and side-effects reports.

Secondary Outcomes (1)

• Reduction in YBOCS scores at week 18

Interventions

escitalopram DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abarbanel Mental Health Center: lead

Study Sites (1)

Abarbanel MHC

Bat Yam, 59100, Israel

Location

Related Publications (3)

• 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. doi: 10.1159/000090702. Epub 2006 Jan 4.

  PMID: 16397403 BACKGROUND

• 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. doi: 10.1080/15622970510029740.

  PMID: 16097406 BACKGROUND

• 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. doi: 10.1097/YIC.0b013e3282f0f0c5.

  PMID: 18090508 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yoram Barak, MD, MHA

  Abarbanel MHC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 21, 2006
• First Posted: March 22, 2006
• Study Start: March 1, 2006
• Study Completion: December 1, 2006
• Last Updated: July 26, 2006

Record last verified: 2006-03

Locations

IL (1)