Major Depressive Disorder
Conditions
Keywords
considered, entry, into, the study, SSRI, Seroquel, Quetiapine, fumarate, antipsychotic
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.
Interventions
300 mg, PO, 100 mg morning, 200 mg evening, 4 weeks
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Montgomery-Asberg Depression Scale (MADRS) score | Visit 1 - > 5 |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| The Brief psychiatric Rating Scale (BPRS) scoreThe Clinical Global impression (CGI) scorePatient reported outcomes (PROs) | Visit 1 - > 5 (1 week between each visit) |
Countries
Belgium
Outcome results
None listed