Efficacy of SEROQUEL in Selective Serotonin Reuptake Inhibitors (SSRI)-Resistant Major Depressive Disorder

NCT ID: NCT00733668

Last Updated: 2009-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-11-30

Brief Summary

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An open-label, non-comparative, multi-centre, phase II prospective trial to assess the efficacy of Quetiapine fumarate augmentation of selective serotonin reuptake inhibitors (SSRIs) in SSRI-resistant major depressive disorder.

Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Quetiapine fumarate (Seroquel)

300 mg, PO, 100 mg morning, 200 mg evening, 4 weeks

Intervention Type DRUG

Other Intervention Names

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Seroquel

Eligibility Criteria

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Inclusion Criteria

* Inform consent
* Male and female, age between 18 and 65 years.
* Naïve to any atypical antipsychotic
* A diagnosis of major depressive disorder

Exclusion Criteria

* No use of fluvoxamine
* Patients with a history of bipolar I or II disorder
* Diagnosis of psychotic major depression disorder
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Pr. Demyttenaere

Role: STUDY_DIRECTOR

KUL

Locations

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Research Site

Bruges, , Belgium

Site Status

Research Site

Leuven, , Belgium

Site Status

Research Site

Liège, , Belgium

Site Status

Research Site

Sint-Truiden, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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D1449C00009

Identifier Type: -

Identifier Source: org_study_id

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