Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Felbamate in Treatment Resistant Bipolar Depression
NCT00034229Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2002
- Countries
- 1
- Sponsor
- National Institute of Mental Health
- Modality
- Allosteric Modulators
- Drugs
- felbamate
- Conditions
- bipolar disorder (BD)
01
Overview
Phase 2, randomised, double-blind trial in bipolar disorder (BD) comparing Felbamate with Placebo (2 arms). Primary endpoint: Response Rate at 8 weeks. Started Apr 2002; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Felbamate
Felbamate (600-3000 mg/day) +/- Lithium
Placebo
Placebo +/- Lithium
03
Who it enrols
Adults with Bipolar I or II disorder (depressed phase) who are treatment-resistant, with a MADRS score >= 20.
04
Endpoints
Primary
Response Rate
Secondary
Safety and Tolerability
Beyond the preview
Go deeper on NCT00034229.
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 NCT00034229.