Depression
Conditions
Brief summary
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.
Interventions
DRUGPlacebo
po daily for 10 days
DRUGRO4917523
orally daily for 10 days, cohorts receiving up to 5 different doses (according to safety and tolerability)
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* adult patients, 18-65 years of age; * recurrent major depressive disorder, without psychotic features; * at least 3 lifetime treatment failures, at least 2 of which must have occurred within the current depressive episode; * baseline minimal severity defined by a HAM-D score of 18 or above; * willing to be hospitalized for at least 16 consecutive days.
Exclusion criteria
* history of bipolar disorder, schizoaffective disorder or schizophrenia; * history of psychosis, including psychotic depression; * significant past or present neurological disorder, including seizures, stroke and/or head trauma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability: Adverse events, ECGs, laboratory parameters,vital signs | Throughout study |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: MADRS score | From baseline to day 10 |
| Symptoms of treatment-resistant depression | Throughout study |
Countries
United States
Outcome results
None listed