NCT00809562CompletedPhase 2
An Exploratory Fixed Dose Randomized Double Blind Parallel-group Placebo-controlled Study of the Safety and of the Therapeutic Effects of Ro 4917523 in Patients With Treatment- Resistant Depression
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 46
- Primary Endpoint
- Safety and tolerability: Adverse events, ECGs, laboratory parameters,vital signs
Study Overview
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.
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;
- •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.
Arms & Interventions
1
Experimental
Intervention: RO4917523 (Drug)
2
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Safety and tolerability: Adverse events, ECGs, laboratory parameters,vital signs
Time Frame: Throughout study
Secondary Outcomes
- Efficacy: MADRS score(From baseline to day 10)
- Symptoms of treatment-resistant depression(Throughout study)
Investigators
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