A Study of RO4917523 in Patients With Treatment Resistant Depression
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00809562
First received: December 16, 2008
Last updated: September 18, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Drug: RO4917523 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Safety and tolerability: Adverse events, ECGs, laboratory parameters,vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Efficacy: MADRS score [ Time Frame: From baseline to day 10 ] [ Designated as safety issue: No ]
- Symptoms of treatment-resistant depression [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 34 |
| Study Start Date: | March 2009 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: RO4917523
orally daily for 10 days, cohorts receiving up to 5 different doses (according to safety and tolerability)
|
| Placebo Comparator: 2 |
Drug: Placebo
po daily for 10 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00809562
Locations
| United States, California | |
| Oceanside, California, United States, 92056 | |
| San Diego, California, United States, 92103 | |
| United States, Connecticut | |
| New Haven, Connecticut, United States, 06511 | |
| United States, Louisiana | |
| Shreveport, Louisiana, United States, 71115 | |
| United States, Mississippi | |
| Flowood, Mississippi, United States, 39232 | |
| United States, New York | |
| New York, New York, United States, 10029 | |
| New York, New York, United States, 10032 | |
| New York, New York, United States, 10065-4870 | |
| United States, Pennsylvania | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00809562 History of Changes |
| Other Study ID Numbers: | NP22022 |
| Study First Received: | December 16, 2008 |
| Last Updated: | September 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013