A Multi-center Randomized Double-blind Placebo-controlled Parallel-group Study to Investigate Efficacy and Safety of RO4995819 vs Placebo, as Adjunct Therapy in Patients w/Major Depressive Disorder
The purpose of the study is to explore the efficacy of 6 weeks treatment of an investigational medication, RO4995819, versus placebo as adjunctive therapy in patients with major depression.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- biological : RO4995819
Phase: Phase 2
Ages Eligible For Study:
Patients are eligible for enrollment in this study if they meet all of the following criteria: 1. An outpatient w/a primary diagnosis of major depressive disorder w/out psychotic features 2. Inadequate response to current, ongoing antidepressant tx of SSRI/SNRI. 3. Having at least 1 but no more than 2 antidepressant treatment failures w/in the index depressive episode 4. Dose/duration of antidepressant treatment in index episode can be verified by documentation from one of following: 1. Med records; 2. Pharmacy records; 3. Treating and/or referring physician (indicating medication, dose, dates of treatment). 5. Documentation of clinical/treatment history must be available. 6. Index depressive episode started w/in 1 year of screening. 7. Confirmed compliance w/current SSRI/SNRI treatment based on blood screen. 8. Existing med regimens should be stable for 6 wks prior to screening 9. 18-65 y.o. at time of consent 10. BMI 18.0 to 35.0 kg/m2 inc. 11. Patients w/reproductive potential must agree to use specified contraceptive protection during tx period and for at least 90 days after last dose of study drug: - Males w/partners of childbearing potential or partners must use a barrier method of contraception or remain sexually abstinent. - Females who are not either surgically sterile (tubal ligation, removal of ovaries or uterus) or post-menopausal (no spontaneous menstrual periods for at least 1 yr confirmed by a hormone panel [FSH and 17?estradiol])must agree to use 2 adequate methods of contraception, including at least one method w/ failure rate of < 1% per yr (e.g., hormonal implants, combined oral contraceptives, vasectomized partner, abstinence). 12. Able to participate and willing to give written informed consent.