The Use of a Mitochondrial Enhancement Treatment in Bipolar Disorder - Full Text View

Sponsors and Collaborators:	Mclean Hospital Stanley Medical Research Institute
Information provided by:	Mclean Hospital
ClinicalTrials.gov Identifier:	NCT00719706

Purpose

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.

Condition	Intervention	Phase
Bipolar Depression	Drug: acetyl-l-carnitine PLUS alpha-lipoic acide Drug: Placebo	Phase II

MedlinePlus related topics: Bipolar Disorder Depression

Drug Information available for: Thioctic acid Carnitine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Mclean Hospital:

Primary Outcome Measures:

The 21-Item Hamilton Depression Rating Scale [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
The Montgomery-Asberg Depression Rating Scale [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
The Young Mania Rating Scale [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression-Severity [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression-Improvement [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Phosphorus MRS Scans on 4T scanner [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	August 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid	Drug: acetyl-l-carnitine PLUS alpha-lipoic acide 1000-3000 mg/day of acetyl-l-carnitine in addition to 600-1800 mg/day of alpha-lipoic acid.
2: Placebo Comparator	Drug: Placebo Placebo

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719706

Contacts

Contact: Brian P Brennan, MD	(617) 855-2911	bbrennan@partners.org
Contact: Jacqueline L Roberts, BA	(617) 855-2434	jroberts@mclean.harvard.edu

Locations

United States, Massachusetts
McLean Hospital	Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Jacqueline L Roberts, BA 617-855-2434 jroberts@mclean.harvard.edu
Contact: Kate V Fogarty, BA (617) 855-2773 kfogarty@mclean.harvard.edu
Principal Investigator: Brian P Brennan, MD
Sub-Investigator: Bruce M Cohen, MD, PhD
Sub-Investigator: Dost Ongur, MD, PhD
Sub-Investigator: James I Hudson, MD, ScD
Sub-Investigator: Harrison G Pope, MD
Sub-Investigator: Eric Jensen, PhD

Sponsors and Collaborators

Mclean Hospital

Stanley Medical Research Institute

Investigators

Principal Investigator:

Brian P Brennan, MD

Mclean Hospital

More Information

Responsible Party:	McLean Hospital ( Brian P. Brennan, M.D.; Associate Director for Translational Neuroscience Research )
Study ID Numbers:	2008-P-00772
Study First Received:	July 18, 2008
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00719706
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mclean Hospital:

Bipolar disorder
Bipolar depression
Natural substances
Depression

Study placed in the following topic categories:

Affective Disorders, Psychotic
Depression
Mental Disorders
Bipolar Disorder
Mood Disorders
Psychotic Disorders

Depressive Disorder
Carnitine
Thioctic Acid
Acetylcarnitine
Behavioral Symptoms

Additional relevant MeSH terms:

Nootropic Agents
Antioxidants
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Growth Substances
Vitamins

Therapeutic Uses
Physiological Effects of Drugs
Micronutrients
Protective Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009