Major Depressive Disorder Clinical Trial
— UNIQUEOfficial 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.
Status | Completed |
Enrollment | 0 |
Est. completion date | November 2007 |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Research Site | Brugge | |
Belgium | Research Site | Leuven | |
Belgium | Research Site | Liege | |
Belgium | Research Site | Sint-Truiden |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Montgomery-Asberg Depression Scale (MADRS) score | Visit 1 - > 5 | No | |
Secondary | The Brief psychiatric Rating Scale (BPRS) scoreThe Clinical Global impression (CGI) scorePatient reported outcomes (PROs) | Visit 1 - > 5 (1 week between each visit) | No | |
Secondary | Sheehan Disability Scale (SDS) score | Visit 1 - > 5 (1 week between each visit) | No | |
Secondary | The Symptom Checklist 90 Revisred (SCL-90-R) score | Visit 1 - > 5 (1 week between each visit) | No |
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