Quetiapine Augmentation in Severe Obsessive Compulsive Disorder

Obsessive Compulsive Disorder Clinical Trial

Official title:

Quetiapine Augmentation in Severe Obsessive Compulsive Disorder (OCD) - Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00254735
• Other study ID #: 5077/9059
• Secondary ID: D1441C09059
• Status: Completed
• Phase: Phase 3
• First received: November 15, 2005
• Last updated: December 14, 2007
• Start date: April 2002
• Est. completion date: March 2006

Study information

• Verified date: December 2007
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the efficacy of quetiapine or placebo added to baseline treatment of SSRI/clomipramine for the treatment of OCD in adult subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Signed informed consent, men and women aged ³18 to £65 years with diagnosis of OCD, at least 12 weeks of treatment with SSRI or clomipramine

Exclusion Criteria:

• Substance abuse or dependence, female patients who are pregnant, lactating or at risk of pregnancy, known intolerance or lack of response to quetiapine, use of antihypertensive medication with changing doses

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

Drug:
• quetiapine fumarate

• SSRI/Clomipramine

Locations

Country	Name	City	State
Germany	Research Site	Freiburg
Germany	Research Site	Lübeck

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change of OCD symptoms from baseline to endpoint on the total Y-BOCS score.
Secondary	Change of comorbid psychiatric symptoms and measures of quality of life from baseline to endpoint documented by different scales.
Secondary	Evaluation of the safety and tolerability profile of quetiapine compared to placebo added to a baseline medication of SSRI/clomipramine.