At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 40 enrolled
Drug / intervention
acetyl-l-carnitine PLUS alpha-lipoic acide +1 moredrug
Likely dose
acetyl-l-carnitine PLUS alpha-lipoic acide 3000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Use of a Mitochondrial Enhancement Treatment in Bipolar Disorder: A Randomized, Placebo-Controlled Trial of Acetyl-L-Carnitine and Alpha-Lipoic Acid for the Treatment of Bipolar Depression
In Brief
A Phase 2 clinical trial evaluating acetyl-l-carnitine PLUS alpha-lipoic acide and Placebo for Bipolar Depression. Completed, enrolled 40 participants across 1 site.
Detailed Summary
The primary objective of this 15-week clinical trial is to test the hypothesis that treatment with two proven mitochondrial enhancers, acetyl-L-carnitine (ALCAR) and α-lipoic acid (ALA), has significantly greater efficacy than placebo as an augmentation treatment in bipolar depressed patients who display an incomplete response to conventional treatments.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Depression
CountriesUnited States
CollaboratorsStanley Medical Research Institute
Timeline
Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2008
Enrollment StartAug 2008
Primary CompletionMay 2011
TodayJul 2026
First PostedJul 22, 2008
Enrollment StartAug 1, 2008
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.9 years ago
Interventions
acetyl-l-carnitine PLUS alpha-lipoic acidedrug
1000-3000 mg/day of acetyl-l-carnitine in addition to 600-1800 mg/day of alpha-lipoic acid.
Placebodrug
Placebo