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Quetiapine Augmentation in Severe Obsessive Compulsive Disorder

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00254735
Enrollment
44
Registered
2005-11-17
Start date
2002-04-30
Completion date
2006-03-31
Last updated
2007-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive Compulsive Disorder

Keywords

Obsessive Compulsive Disorder (OCD)

Brief 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.

Interventions

DRUGquetiapine fumarate
DRUGSSRI/Clomipramine

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Change of comorbid psychiatric symptoms and measures of quality of life from baseline to endpoint documented by different scales.
Evaluation of the safety and tolerability profile of quetiapine compared to placebo added to a baseline medication of SSRI/clomipramine.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026