drugset / Trial / NCT01703039

Riluzole Augmentation Pilot in Depression (RAPID) Trial

NCT01703039 ↗

Phase 2 Terminated 21 enrolled Brigham and Women's Hospital
RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start
2013-01
Primary completion
2018-06
Completion
2018-06

Outcome

Missed primary endpoint

Stopped (Enrollment): “PI departure, slow recruitment”

registry analysis (superiority test); Sertraline + Riluzole vs Sertraline + Placebo; p = 0.06; ANOVA NCT01703039 ↗

registry analysis (superiority test); Sertraline + Riluzole vs Sertraline + Placebo; p = 0.31; Chi-squared NCT01703039 ↗

registry analysis (superiority test); Sertraline + Riluzole vs Sertraline + Placebo; p = 0.34; Chi-squared NCT01703039 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Riluzole Small molecule 50 mg Oral
Background Sertraline Small molecule 100 mg Oral