NCT01457677CompletedPhase 2
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)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 357
- Primary Endpoint
- Mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
RO4995819 15 mg
Experimental
Intervention: RO4995819 (Drug)
RO4995819 30 mg
Experimental
Intervention: RO4995819 (Drug)
RO4995819 5 mg
Experimental
Intervention: RO4995819 (Drug)
Outcomes
Primary Outcomes
Mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores
Time Frame: 6 weeks
Secondary Outcomes
- Safety (incidence of a adverse events)(6 weeks)
- Proportion of patients exhibiting remission based on the Montgomery Asberg Depression Rating Scale (MADRS) (score of </=10)(6 weeks)
- Proportion of patients exhibiting response based on the Montgomery Asberg Depression Rating Scale (MADRS) (reduction in score of >/= 50% of the baseline score)(6 weeks)
Investigators
Similar Trials
Withdrawn
Phase 2
A Study of RO6811135 in Patients With Type 2 Diabetes Who Are Inadequately Controlled With MetforminDiabetes Mellitus Type 2NCT01951183Hoffmann-La Roche
Completed
Phase 3
A Study of Gantenerumab in Participants With Prodromal Alzheimer's DiseaseAlzheimer's DiseaseNCT01224106Hoffmann-La Roche799
Completed
Phase 3
CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema AttacksHereditary AngioedemaNCT04656418CSL Behring64
Unknown
Phase 3
A Study to Evaluate Botulinum Toxin Type A for Injection（HengLi®）for Prophylactic Treatment of Chronic MigraineChronic MigraineNCT02291380Lanzhou Institute of Biological Products Co., Ltd288
Terminated
Phase 3
A Multicentre Study to Evaluate the Efficacy and Safety of ENIA11 in Patients With Ankylosing SpondylitisAnkylosing SpondylitisNCT02685904Mycenax Biotech Inc.10