Simvastatin Augmentation of Lithium Treatment in Bipolar Depression
- Registration Number
- NCT01665950
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
Primary Aim: To estimate the antidepressant efficacy of simvastatin versus placebo as an adjunct to lithium, valproate, and/or other atypical antipsychotic therapy among individuals with bipolar I disorder in a nonpsychotic major depressive episode.
Hypothesis: Simvastatin will be superior to placebo in improvement of depressive symptoms assessed by the Montgomery-Asberg Depression Rating Scale (MADRS).
- Detailed Description
(see brief summary)
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo->Simvastatin Placebo Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the next 4 weeks Placebo-Placebo Placebo Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the subsequent 4 weeks Placebo->Simvastatin Simvastatin Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the next 4 weeks Simvastatin-Simvastatin Simvastatin Subjects will receive simvastatin in phase 1 (4 weeks) and phase 2 (4 weeks)
- Primary Outcome Measures
Name Time Method Change in MADRS (4 Weeks) Baseline vs week 4 (and, for placebo nonresponders in 1st 4 weeks, week 8 vs week 4) Change in Montgomery-Asberg Depression Rating Scale (MADRS) in simvastatin-treated epochs versus placebo-treated epochs
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States