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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- Stanford University
- Primary Endpoint
- Montgomery Asberg Depression Rating Scale
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
The investigators hope to learn the efficacy of 6 weeks treatment of RO4995819 versus placebo as adjunctive therapy in patients with MDD having inadequate response to ongoing antidepressant treatment based on mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores from baseline to end of treatment. This knowledge is valuable because it is a new medication, which may have utility in the population of patients with major depressive disorder.
Investigators
Charles DeBattista
Principle Investigator
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Patients are eligible for enrollment in this study if they meet all of the following criteria:
- •An outpatient w/a primary diagnosis of major depressive disorder w/out psychotic features
- •Inadequate response to current, ongoing antidepressant tx of SSRI/SNRI.
- •Having at least 1 but no more than 2 antidepressant treatment failures w/in the index depressive episode
- •Dose/duration of antidepressant treatment in index episode can be verified by documentation from one of following:
- •Med records;
- •Pharmacy records;
- •Treating and/or referring physician (indicating medication, dose, dates of treatment).
- •Documentation of clinical/treatment history must be available.
- •Index depressive episode started w/in 1 year of screening.
Exclusion Criteria
- •Patients are excluded from this study if the answer is 'yes' to any of the following:
- •Current and past treatment history:
- •Currently receiving tx w/3 or more antidepressants.
- •Currently receiving tx w/prohibited meds.
- •Significant ongoing use of high doses of barbiturates, benzodiazepines or other anxiolytic drugs.
- •Previously received RO
- •Participated in investigational drug or device study w/in 6 mos of screening or in index depressive episode.
- •History of non-response to Electroconvulsive Therapy (ECT), Vagus Nerve Stimulation (VNS),or Repetitive Transcranial Magnetic Stimulation (RTMS).
- •Planning to begin/change current regimen of individual psychotherapy including cognitive behavioral therapy during the 6 week treatment period of the study and the first 2 weeks of follow-up.
- •Present DSM-IV-TR axis I diagnosis except for anxiety comorbidity
Outcomes
Primary Outcomes
Montgomery Asberg Depression Rating Scale
Time Frame: 6 weeks
The investigators hope to learn the efficacy of 6 weeks treatment of RO4995819 versus placebo as adjunctive therapy in patients with MDD having inadequate response to ongoing antidepressant treatment based on mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores from baseline to end of treatment. This knowledge is valuable because it is a new medication, which may have utility in the population of patients with major depressive disorder.