Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Riluzole in Bipolar Depression
NCT00054704Phase 2
Key facts
- Status
- Terminated
- Start
- Feb 2003
- Primary completion
- Dec 2014
- Countries
- 1
- Sponsor
- National Institute of Mental Health
- Modality
- Small Molecules
- Drugs
- riluzole
- Conditions
- bipolar disorder (BD)
01
Overview
Phase 2, randomised, double-blind trial in bipolar disorder (BD) comparing Riluzole with Placebo (2 arms). Primary endpoint: Montgomery-Asberg Depression Rating Scale at 8 weeks. Started Feb 2003; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Riluzole
Riluzole 50 mg tablets, starting at 50 mg twice daily and titrated up to 200 mg/day.
Placebo
Placebo pills matching Riluzole, starting at 50 mg twice daily equivalent and titrated up to 200 mg/day equivalent.
03
Who it enrols
Adults 18-70 years old with bipolar I or II disorder, currently in a depressive episode for at least 4 weeks with a MADRS score >= 20, who have failed at least one prior antidepressant. Excludes patients with psychotic features, serious suicidal risk, or recent substance abuse.
04
Endpoints
Primary
Montgomery-Asberg Depression Rating Scale
Beyond the preview
Go deeper on NCT00054704.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT00054704.