A Study of RO4917523 in Patients With Treatment Resistant Depression
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
1 other identifier
interventional
46
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 depression
Started Mar 2009
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2008
CompletedFirst Posted
Study publicly available on registry
December 17, 2008
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedNovember 2, 2016
November 1, 2016
1.9 years
December 16, 2008
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and tolerability: Adverse events, ECGs, laboratory parameters,vital signs
Throughout study
Secondary Outcomes (2)
Efficacy: MADRS score
From baseline to day 10
Symptoms of treatment-resistant depression
Throughout study
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Unknown Facility
Oceanside, California, 92056, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
New Haven, Connecticut, 06511, United States
Unknown Facility
Shreveport, Louisiana, 71115, United States
Unknown Facility
Flowood, Mississippi, 39232, United States
Unknown Facility
New York, New York, 10029, United States
Unknown Facility
New York, New York, 10032, United States
Unknown Facility
New York, New York, 10065-4870, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2008
First Posted
December 17, 2008
Study Start
March 1, 2009
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
November 2, 2016
Record last verified: 2016-11