Riluzole Augmentation Pilot in Depression (RAPID) Trial (RAPID)
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|ClinicalTrials.gov Identifier: NCT01703039|
Recruitment Status : Recruiting
First Posted : October 10, 2012
Last Update Posted : April 19, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Riluzole Drug: Sertraline Other: placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Riluzole Augmentation Pilot in Depression (RAPID) Trial|
|Actual Study Start Date :||January 2013|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||September 2019|
Experimental: sertraline + riluzole
sertraline 100 mg po daily and riluzole 50 mg po bid
Other Name: Rilutek
Other Name: Zoloft
Active Comparator: sertraline + placebo
sertraline 100 mg po daily and placebo
Other Name: Zoloft
- Mean change in Hamilton Depression Rating Scale (HDRS) score from baseline to endpoint at 8 weeks [ Time Frame: 8 weeks ]
- Proportion of patients experiencing an antidepressant response (>50% reduction in HDRS) at endpoint of 8 weeks [ Time Frame: 8 weeks ]
- Proportion of patients experiencing remission from depression (HDRS<7) at endpoint of 8 weeks [ Time Frame: 8 weeks ]
- Mean change in Hamilton Anxiety Rating Scale (HARS) score from baseline to endpoint at 8 weeks [ Time Frame: 8 weeks ]
- Mean change in Clinical Global Impression (CGI) scale from baseline to endpoint at 8 weeks [ Time Frame: 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01703039
|Contact: Molly O'Reilly, MA||617-525-8443||RAPID@PARTNERS.ORG|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Molly O'Reilly, MA RAPID@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|