The Use of a Mitochondrial Enhancement Treatment in Bipolar Disorder

Mass General Brigham

Status and phase

Completed

Phase 2

Conditions

Bipolar Depression

Treatments

Drug: acetyl-l-carnitine PLUS alpha-lipoic acide

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00719706

2008-P-000772

Details and patient eligibility

About

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.

Full description

The primary objective of this proposed 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. We propose to test this hypothesis by performing a 15-week placebo-controlled, double-blind, parallel group, flexible-dose study investigating the use of ALCAR and ALA as an augmentation to treatment as usual in depressed bipolar patients. We will compare the efficacy of acetyl-l-carnitine (ALCAR) at doses of 1000-3000mg/day and alpha-lipoic acid (ALA) at doses of 600-1800mg/day with placebo on symptom improvement in individuals diagnosed with bipolar disorder type I, current episode depressed. Improvement will be assessed using the 21-Item Hamilton Depression Rating Scale (HAM-D), the Montgomery Asberg Depression Rating Scale (MADRS), the Young Mania Rating Scale (YMRS), and the Clinical Global Impression-Severity and Improvement Scales (CGI-S and CGI-I).

Furthermore, we hypothesize that improvement in depression symptoms following treatment with ALCAR and ALA will be associated with increases in phosphocreatine (PCr), beta-nucleoside triphosphate (β-NTP), and intracellular pH in the anterior cingulate cortex (ACC) both at week 1 and week 12 of treatment.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.