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

Hoffmann-La Roche0 sites46 target enrollmentMarch 2009

ConditionsDepression

InterventionsRO4917523 Placebo

DrugsPlacebo RO4917523

Overview

Phase: Phase 2
Intervention: RO4917523
Conditions: Depression
Sponsor: Hoffmann-La Roche
Enrollment: 46
Primary Endpoint: Safety and tolerability: Adverse events, ECGs, laboratory parameters,vital signs
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

February 2011

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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.