ARTDeCo Study: A Study of RO4995819 in Patients With Major Depressive Disorder And Inadequate Response to Ongoing Antidepressant Treatment
| Status: | Completed |
|---|---|
| Conditions: | Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 8/3/2016 |
| Start Date: | December 2011 |
| End Date: | June 2014 |
A Multi Center, Randomized, Double-blind, Placebo Controlled, Parallel-group Study to Investigate the Efficacy and Safety of RO4995819 Versus Placebo, as Adjunctive Therapy in Patients With Major Depressive Disorder Having Inadequate Response to Ongoing Antidepressant Treatment (ARTDeCo)
This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will
investigate the efficacy and safety of RO4995819 as adjunctive therapy in patients with
major depressive disorder having inadequate response to ongoing antidepressant treatment.
Patients will be randomized to receive once daily doses of 5 mg, 15 or 30 mg of RO4995819 or
matching placebo. The anticipated time on study treatment is 6 weeks.
investigate the efficacy and safety of RO4995819 as adjunctive therapy in patients with
major depressive disorder having inadequate response to ongoing antidepressant treatment.
Patients will be randomized to receive once daily doses of 5 mg, 15 or 30 mg of RO4995819 or
matching placebo. The anticipated time on study treatment is 6 weeks.
Inclusion Criteria:
- Adult patients, 18-65 years of age
- Major depression disorder without psychotic features
- Inadequate response to current, ongoing antidepressant treatment as defined by
protocol
- Having at least one but no more than 2 antidepressant treatment trial failures
- Body mass index (BMI) 18.0-35.0 kg/m2 inclusive
Exclusion Criteria:
- Patient currently receives treatment with a combination of 3 or more antidepressants
- Significant ongoing use of high doses of barbiturates, benzodiazepines or other
anxiolytic drugs
- Patient previously received RO4995819
- Patient participated in an investigational drug or device trial within 6 months of
screening
- History of non-response to, or current use of non-pharmacological treatment including
Electroconvulsive Therapy (ECT), Vagus Nerve Stimulation (VNS), or Repetitive
Transcranial Magnetic Stimulation (RTMS)
- Past or present psychotic symptoms
We found this trial at
44
sites
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