The Use of a Mitochondrial Enhancement Treatment in Bipolar Disorder

Completed · Phase 2 · Has a placebo group

Conditions studied: Bipolar Depression

In brief

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.

Key facts

Study ID

NCT00719706

Run by

Mclean Hospital

People needed

40

Starts

2008-08-01

Expected to finish

2011-05-01

Last updated by the study team

2012-07-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• McLean Hospital — Belmont, Massachusetts, United States

Full record on ClinicalTrials.gov

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