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Simvastatin Augmentation in Bipolar Depression
NCT01665950Phase 2
Key facts
- Status
- Terminated
- Start
- Aug 2012
- Primary completion
- Oct 2014
- Countries
- 1
- Sponsor
- Massachusetts General Hospital
- Modality
- Small Molecules
- Drugs
- simvastatin
- Conditions
- bipolar I disorder
01
Overview
Phase 2, randomised, double-blind trial in bipolar I disorder comparing Simvastatin -> Simvastatin, Placebo -> Simvastatin and Placebo -> Placebo (3 arms). Primary endpoint: Montgomery-Asberg Depression Rating Scale at 4 weeks. Started Aug 2012; status: terminated.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Simvastatin -> Simvastatin
Simvastatin in Phase 1 and Phase 2
Placebo -> Simvastatin
Placebo in Phase 1, Simvastatin in Phase 2 (Non-responders)
Placebo -> Placebo
Placebo in Phase 1 and Phase 2
03
Who it enrols
Adults with Bipolar I Disorder in a current major depressive episode (MADRS 20-34) on stable lithium, valproate, or atypical antipsychotic therapy.
04
Endpoints
Primary
Montgomery-Asberg Depression Rating Scale
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