The Use of a Mitochondrial Enhancement Treatment in Bipolar Disorder

Bipolar Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719706
• Other study ID #: 2008-P-000772
• Status: Completed
• Phase: Phase 2
• First received: July 18, 2008
• Last updated: June 13, 2012
• Start date: August 2008
• Est. completion date: May 2011

Study information

• Verified date: June 2012
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

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.
• Placebo
Placebo

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mclean Hospital	Stanley Medical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The 25-Item Hamilton Depression Rating Scale.	Scores could range from 0 - 72 units on a scale, with 0 representing the least number of depressive symptoms and 72 representing the most number of depressive symptoms.	Baseline to 15 Weeks	No
Primary	The Montgomery-Asberg Depression Rating Scale	Scores could range from 0 - 60 units on a scale with 0 representing the least number of depressive symptoms and 60 representing the most number of depressive symptoms.	Baseline to 15 weeks	No
Primary	The Young Mania Rating Scale	The scores could range from 0 - 60 units on a scale with 0 representing the least number of manic symptoms and 60 representing the most number of manic symptoms.	Baseline to 15 weeks	No
Primary	Clinical Global Impression-Severity	Scores could range from 0 - 7 units on a scale, with 0 representing the least severe ("Normal, not at all ill") and 7 representing the most severe ("Among the most extremely ill patients").	Baseline to 15 weeks	No
Secondary	Phosphorus MRS Scans on 4T Scanner	Whole brain total NTP levels as measured by a phosphorus MRS scan on the 4T scanner. The data could range from 0 - 1, with 0 representing the lowest NTP level and 1 representing the highest NTP level.	Baseline to 12 weeks	No