Major Depressive Disorder MedDRA version: 14.1 Level: PT Classification code 10012378 Term: Depression System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 14.1 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: mGluR2/3 Antagonist
Product Code: RO4995819/F04
Pharmaceutical Form: Capsule, hard
CAS Number: 911115-16-7
Current Sponsor code: RO4995819-010
Other descriptive name: mGluR2/3 Antagonist
Sponsors
F. Hoffmann-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • A primary diagnosis of MDD without psychotic features • Having inadequate response to current antidepressant treatment • Having at least 1 but no more than 2 antidepressant treatment trial failures within the index depressive episode • Index depressive episode started within 1 year • 18 up to 65 years of age • BMI between 18.0 to 35.0 kg/m2 inclusive • Patients with reproductive potential must agree to use specified contraceptive protection Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 170 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 170
Exclusion criteria
Exclusion criteria: • Previously received RO4995819 • History of non-response to, or current use of a non-pharmacological treatment • Present DSM-IV-TR axis I diagnosis except anxiety comorbidity • Past or present psychotic symptoms • Mood disorder due to medical condition or substance use/abuse/dependence • Established personality disorder • Alcohol and/or substance abuse/dependence • A current (at screening) significant risk for suicidal behavior as judged by the Investigator following a thorough clinical evaluation and supported by information collected on the C-SSRS • Significant or unstable other medical condition that could interfere with the conduct of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate 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. ;Secondary Objective: 1. To investigate the safety and tolerability of RO4995819 2. To evaluate the efficacy of RO4995819 versus placebo, according to other efficacy measures 3. To investigate the PK of RO4995819 4. To investigate exposure-response/safety relationships of RO4995819 5. To investigate dynamic biomarkers of depression and treatment response 6. To investigate the impact of known genetic variants on the safety, PK, PD, and efficacy ;Primary end point(s): Change in the MADRS total score from baseline to end of treatment;Timepoint(s) of evaluation of this end point: Weekly assessments from baseline to 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Endpoints related to other efficacy objectives, safety, tolerability, pharmacokinetics and exposure-response/safety relationships of RO4995819;Timepoint(s) of evaluation of this end point: Up to weekly assessments from baseline to end of study | — |
Countries
Austria, Canada, Germany, Russian Federation, Slovakia, South Africa, Ukraine, United States
Contacts
Public ContactTrial Information Support Line-TISL
F.Hoffmann-La Roche Ltd.
Outcome results
None listed