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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00733668
Recruitment Status : Completed
First Posted : August 13, 2008
Last Update Posted : March 25, 2009
Information provided by:

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

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Study Type : Interventional  (Clinical Trial)
Allocation: N/A
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

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) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT00733668

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Research Site
Brugge, Belgium
Research Site
Leuven, Belgium
Research Site
Liege, Belgium
Research Site
Sint-Truiden, Belgium
Sponsors and Collaborators
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Study Director: Pr. Demyttenaere KUL
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Responsible Party: An Matthys, MD, Therapeutic Area Leader CNS, AstraZeneca Pharmaceuticals Identifier: NCT00733668    
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:
the study
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs