The Use of a Mitochondrial Enhancement Treatment in Bipolar Disorder

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mclean Hospital
• Collaborator: Stanley Medical Research Institute
• Treatments: Acetylcarnitine; Thioctic Acid

Criteria

Inclusion Criteria:

• Male or female age 18-65 years.

• Meets DSM-IV criteria for Bipolar Disorder, type I with current episode depressed.

• Current score of greater than or equal to 18 on the 21-Item Hamilton Depression Rating Scale at Visits 1 and 2.

• Maintained on a stable treatment regimen with no changes in medication dosages for at least two weeks prior to study entry.

Exclusion Criteria:

• Unwilling or unable to provide informed consent

• Score of greater than or equal to 12 on the Young Mania Rating Scale at Visit 1 or 2.

• Current suicidal or homicidal ideation.

• Active psychotic symptoms.

• Lifetime history of schizophrenia or obsessive-compulsive disorder.

• DSM-IV diagnosis of alcohol or substance dependence in the 3 months prior to screening.

• Clinically significant medical condition that would interfere with study participation.

• History of hypersensitivity to ACLCAR or ALA.

• Pregnant or lactating.