Major Depressive Disorder Clinical Trial
Official title:
A Randomized, Double-blind, Parallel-group Study of the Safety and Efficacy of RO4917523 Versus Placebo, as Adjunctive Therapy in Patients With Major Depressive Disorder With Inadequate Response to Ongoing Antidepressant Treatment
Verified date | November 2016 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This randomized, double-blind, placebo-controlled, parallel group study will evaluate the safety and efficacy of RO4917523 as adjunctive therapy in patients with major depressive disorder and an inadequate response to ongoing antidepressant therapy. Anticipated time on study treatment is 6 weeks with a 3-week follow-up.
Status | Completed |
Enrollment | 319 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Adult patient, 18 to 70 years of age at time of informed consent - Major depressive disorder without psychotic features as defined by DSM-IV-TR criteria - Inadequate response to ongoing antidepressant treatment, as defined by protocol - Body mass index (BMI) 18 to 38 kg/m2 inclusive Exclusion Criteria: - Currently receiving treatment with a combination of antidepressants (two or more), or an adjunctive potentiating treatment as defined by protocol - Previously received RO4917523 - History of failure, or utilization during the current episode of Electroconvulsive Therapy (ECT) or repetitive Transcranial Magnetic Stimulation (rTMS) - History of use at any time of Vagus Nerve Stimulation (VNS) or Deep Brain Stimulation (DBS) - Current or past history of bipolar disorder (e.g. manic, hypomanic, or mixed episodes) - Pregnant or lactating women |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
United States, Chile, Germany, Japan, Mexico, Poland, Romania, Russian Federation, Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Montgomery Asberg Depression Rating Scale (MADRS) | From baseline to Week 6 | No | |
Secondary | Change in Clinical Global Impression Score - Severity (CGI-S) | From baseline to Week 6 | No | |
Secondary | Change in Clinical Global Impression Score - Improvement (CGI-I) | From baseline to Week 6 | No | |
Secondary | Safety: Incidence of adverse events | approximately 2 years | No | |
Secondary | Proportion of patients exhibiting remission (MADRS </= 10) after 6 weeks of treatment | approximately 2 years | No | |
Secondary | Proportion of patients exhibiting response (reduction in MADRS >/= 50% of baseline score) after 6 weeks of treatment | approximately 2 years | No |
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