This study will evaluate the safety, tolerability and efficacy of RO4917523, in comparison to placebo, in patients with treatment-resistant depression. Following a washout period from existing anti-depressant medication, cohorts of patients will be randomized to receive daily oral RO4917523 at up to five different doses (according to the safety and tolerability observed at the lower doses during the study), or placebo. The anticipated time on study treatment is 10 days (in an inpatient unit), and the target sample size is \<100 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
46
Unnamed facility
Oceanside, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
New Haven, Connecticut, United States
Unnamed facility
Shreveport, Louisiana, United States
Safety and tolerability: Adverse events, ECGs, laboratory parameters,vital signs
Time frame: Throughout study
Efficacy: MADRS score
Time frame: From baseline to day 10
Symptoms of treatment-resistant depression
Time frame: Throughout study
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Unnamed facility
Flowood, Mississippi, United States
Unnamed facility
New York, New York, United States
Unnamed facility
New York, New York, United States
Unnamed facility
New York, New York, United States
Unnamed facility
Pittsburgh, Pennsylvania, United States