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: Treatment, Open Label, Single Group Assignment

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

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

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

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Pr. Demyttenaere Study Director KUL  

Information obtained from ClinicalTrials.gov on July 02, 2009

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