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

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ClinicalTrials.gov Identifier: NCT00733668
Recruitment Status : Completed
First Posted : August 13, 2008
Last Update Posted : March 25, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Quetiapine fumarate (Seroquel) Phase 2

Study Type : Interventional  (Clinical Trial)
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : March 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: Quetiapine fumarate (Seroquel)
    300 mg, PO, 100 mg morning, 200 mg evening, 4 weeks
    Other Name: Seroquel


Primary Outcome Measures :
  1. The Montgomery-Asberg Depression Scale (MADRS) score [ Time Frame: Visit 1 - > 5 ]

Secondary Outcome Measures :
  1. 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) ]
  2. Sheehan Disability Scale (SDS) score [ Time Frame: Visit 1 - > 5 (1 week between each visit) ]
  3. The Symptom Checklist 90 Revisred (SCL-90-R) score [ Time Frame: Visit 1 - > 5 (1 week between each visit) ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733668


Locations
Belgium
Research Site
Brugge, Belgium
Research Site
Leuven, Belgium
Research Site
Liege, Belgium
Research Site
Sint-Truiden, Belgium
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Pr. Demyttenaere KUL

Responsible Party: An Matthys, MD, Therapeutic Area Leader CNS, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00733668     History of Changes
Other Study ID Numbers: D1449C00009
First Posted: August 13, 2008    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
considered
entry
into
the study
SSRI
Seroquel
Quetiapine
fumarate
antipsychotic

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Quetiapine Fumarate
Serotonin
Serotonin Uptake Inhibitors
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators