Efficacy of mirtazapine for sleep disturbance and anxiety symptoms compared with selective serotonin reuptake inhibitors in patients with major depressive disorder: a multicenter open-label randomized controlled trial.
- Conditions
- Major depressive disorder
- Registration Number
- JPRN-UMIN000004144
- Lead Sponsor
- Department of Psychiatry, Chiba University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 120
Not provided
1. Patients without 20-75 years of age at study entry 2. Patients treated to current major depressive episode with the antidepressants as the trial intervention 3. Allergy against mirtazapine, paroxetine, and sertraline 4. Patients treated with pimozide 5. Patients treating with or discontinued within 14 days with selegiline, monoamine oxidase inhibitors 6. Patients with severe hormone diseases 7. Significant risk of suicide (HDRS-17 suicide score 3 or over) 8. Pregnant women or women, who may be pregnant 9. Breast-feeding women 10. Patients with substance abuse/dependence 11. Patients with alcohol abuse/dependence 12. Patients with dementia, bipolar or psychotic disorders, those with a primary diagnosis of obsessive-compulsive disorder or an eating disorder 13. Patient whom examination doctor judge improper as a trial subject
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of patients taking benzodiazepines at 6, 12, and 24 weeks
- Secondary Outcome Measures
Name Time Method 1) Response rate by Hamilton Depression Rating Scale(HDRS17) 2) Athene Insomnia Scale (AIS) 3) Zung Self-rating Depression Scale (SDS) 4) Incidence rate of activation syndrome 5) Incidence rate of discontinuation symptoms 6) Clinical Global Inventory (CGI) 7) Serum levels of brain-derived neurotrophic factor (BDNF) at baseline, 6, 12, and 24 weeks 8) five year follow-up of patients