Status:
COMPLETED
The Use of a Mitochondrial Enhancement Treatment in Bipolar Disorder
Lead Sponsor:
Mclean Hospital
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Bipolar Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 significa...
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 signific...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00719706
Start Date
August 1 2008
End Date
May 1 2011
Last Update
July 18 2012
Active Locations (1)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478