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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00733668
First received: August 12, 2008
Last updated: March 24, 2009
Last verified: March 2009
  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 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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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:
considered
entry
into
the study
SSRI
Seroquel
Quetiapine
fumarate
antipsychotic

Additional relevant MeSH terms:
Depressive Disorder, Major
Depressive Disorder
Depression
Disease
Mood Disorders
Mental Disorders
Behavioral Symptoms
Pathologic Processes
Quetiapine
Serotonin Uptake Inhibitors
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents

ClinicalTrials.gov processed this record on September 16, 2014