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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00733668

Purpose

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.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Quetiapine fumarate (Seroquel)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	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.

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Serotonin Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The Montgomery-Asberg Depression Scale (MADRS) score [ Time Frame: Visit 1 - > 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The Brief psychiatric Rating Scale (BPRS) scoreThe Clinical Global impression (CGI) scorePatient reported outcomes (PROs) [ Time Frame: Visit 1 - > 5 (1 week between each visit) ] [ Designated as safety issue: No ]
Sheehan Disability Scale (SDS) score [ Time Frame: Visit 1 - > 5 (1 week between each visit) ] [ Designated as safety issue: No ]
The Symptom Checklist 90 Revisred (SCL-90-R) score [ Time Frame: Visit 1 - > 5 (1 week between each visit) ] [ Designated as safety issue: No ]

Study Start Date:	March 2006
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733668

Locations

Belgium
Research Site
Liege, Belgium
Research Site
Leuven, Belgium
Research Site
Brugge, Belgium
Research Site
Sint-Truiden, Belgium

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Pr. Demyttenaere

KUL

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( An Matthys, MD, Therapeutic Area Leader CNS )
Study ID Numbers:	D1449C00009
Study First Received:	August 12, 2008
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00733668 History of Changes
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by AstraZeneca:

considered
entry
into
the study
SSRI

Seroquel
Quetiapine
fumarate
antipsychotic

Study placed in the following topic categories:

Neurotransmitter Agents
Depression
Tranquilizing Agents
Psychotropic Drugs
Central Nervous System Depressants
Depressive Disorder, Major
Depressive Disorder

Antipsychotic Agents
Serotonin Uptake Inhibitors
Serotonin
Behavioral Symptoms
Quetiapine
Mental Disorders
Mood Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Depression
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Depressive Disorder, Major
Depressive Disorder

Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Quetiapine
Serotonin Agents
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 26, 2009