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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: August 12, 2008
Last updated: March 24, 2009
Last verified: March 2009
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 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00733668

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

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

Keywords provided by AstraZeneca:
the study

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

ClinicalTrials.gov processed this record on May 24, 2016