Efficacy of SEROQUEL in Selective Serotonin Reuptake Inhibitors (SSRI)-Resistant Major Depressive Disorder
Phase 2
Completed
- Conditions
- Major Depressive Disorder
- Registration Number
- NCT00733668
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Inform consent
- Male and female, age between 18 and 65 years.
- Naïve to any atypical antipsychotic
- A diagnosis of major depressive disorder
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Exclusion Criteria
- No use of fluvoxamine
- Patients with a history of bipolar I or II disorder
- Diagnosis of psychotic major depression disorder
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The Montgomery-Asberg Depression Scale (MADRS) score Visit 1 - > 5
- Secondary Outcome Measures
Name Time Method The Brief psychiatric Rating Scale (BPRS) scoreThe Clinical Global impression (CGI) scorePatient reported outcomes (PROs) Visit 1 - > 5 (1 week between each visit) Sheehan Disability Scale (SDS) score Visit 1 - > 5 (1 week between each visit) The Symptom Checklist 90 Revisred (SCL-90-R) score Visit 1 - > 5 (1 week between each visit)
Trial Locations
- Locations (1)
Research Site
🇧🇪Sint-Truiden, Belgium