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

Verified by: AstraZeneca, March 2009
First Received: August 12, 2008 | Last Updated: March 24, 2009 | Phase: Phase 2 | Start Date: March 2006
Overall Status: Completed |
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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...

Brief Summary

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.”

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 Type: Interventional
  • Study Design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: November 2007

Intervention(s) in this Clinical Trial

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

Outcome Measures for this Clinical Trial

Primary Measures

  • The Montgomery-Asberg Depression Scale (MADRS) score
    • Time Frame: Visit 1 - > 5
      Safety Issue?: No

Secondary 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)
      Safety Issue?: No
  • Sheehan Disability Scale (SDS) score
    • Time Frame: Visit 1 - > 5 (1 week between each visit)
      Safety Issue?: No
  • The Symptom Checklist 90 Revisred (SCL-90-R) score
    • Time Frame: Visit 1 - > 5 (1 week between each visit)
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Pr. Demyttenaere Study Director KUL  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00733668

Study ID Number: D1449C00009

ClinicalTrials.gov Identifier: NCT00733668

Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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