Riluzole Augmentation Pilot in Depression (RAPID) Trial
The investigators are doing a research study to find out if riluzole, when taken along with a standard antidepressant (sertraline) can help people with major depression.
This research study will compare riluzole + sertraline to placebo + sertraline. The investigators hypothesize that adding riluzole will lead to a better antidepressant response, in less time, then sertraline alone.
Major Depressive Disorder
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Riluzole Augmentation Pilot in Depression (RAPID) Trial|
- Mean change in Hamilton Depression Rating Scale (HDRS) score from baseline to endpoint at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Proportion of patients experiencing an antidepressant response (>50% reduction in HDRS) at endpoint of 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Proportion of patients experiencing remission from depression (HDRS<7) at endpoint of 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Mean change in Hamilton Anxiety Rating Scale (HARS) score from baseline to endpoint at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Mean change in Clinical Global Impression (CGI) scale from baseline to endpoint at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: sertraline + riluzole
sertraline 100 mg po daily and riluzole 50 mg po bid
Other Name: RilutekDrug: Sertraline
Other Name: Zoloft
Active Comparator: sertraline + placebo
sertraline 100 mg po daily and placebo
Other Name: ZoloftOther: placebo
Recent attention has focused on the glutamatergic system as a new, distinct target for depression treatment. Riluzole (Rilutek, Sanofi), an oral modulator of glutamate activity with neuroprotective and anticonvulsant properties, is currently approved by the United States Food and Drug Administration for treatment of amyotrophic lateral sclerosis (ALS). Preliminary studies using riluzole to treat depression in humans are promising, though larger, double-blinded controlled trials are needed.
Overall study population:
Adult outpatients with a current, untreated major depressive episode.
Disallowed therapies include: other psychotropic medications, including antipsychotics, mood stabilizers, benzodiazepines, barbiturates, other sedative-hypnotics, chronic opiates, or additional antidepressants, psychotherapy, electroconvulsive therapy, vagal nerve stimulations therapy, transcranial magnetic stimulation therapy, or phototherapy.
|Contact: David J Wolfe, MD||617-525-8806||DWOLFE@PARTNERS.ORG|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Sutanuka Lahiri, MS SLAHIRI@PARTNERS.ORG|
|Contact: David Wolfe, MD DWOLFE@PARTNERS.ORG|
|Principal Investigator: David J Wolfe, MD, MPH|
|Principal Investigator:||David J Wolfe, MD||Brigham and Women's Hospital|