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Completed

NCT Number: NCT00254735

Quetiapine Augmentation in Severe Obsessive Compulsive Disorder

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.

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Key information

Conditions

Obsessive Compulsive Disorder Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Freiburg im Breisgau, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quetiapine fumarate

Drug

SSRI/Clomipramine

Drug

Primary outcomes

  1. Absolute change of OCD symptoms from baseline to endpoint on the total Y-BOCS score.

Secondary outcomes

  1. Change of comorbid psychiatric symptoms and measures of quality of life from baseline to endpoint documented by different scales.

  2. Evaluation of the safety and tolerability profile of quetiapine compared to placebo added to a baseline medication of SSRI/clomipramine.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2006
First posted
Nov 17, 2005
Registry last updated
Dec 18, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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