Phase 2
Completed N=40
The Use of a Mitochondrial Enhancement Treatment in Bipolar Disorder
Source: ClinicalTrials.gov NCT00719706 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcomePrimary: The 25-Item Hamilton Depression Rating Scale. — 23.3; 22.1; 17.5; 18.5 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The 25-Item Hamilton Depression Rating Scale. |
23.3; 22.1; 17.5; 18.5 | — |
| PRIMARY The Montgomery-Asberg Depression Rating Scale |
26.9; 25.9; 19.6; 21.7 | — |
| PRIMARY The Young Mania Rating Scale |
2; 2.4; 1.7; 2.1 | — |
| PRIMARY Clinical Global Impression-Severity |
4.6; 4.6; 4; 4.2 | — |
| SECONDARY Phosphorus MRS Scans on 4T Scanner |
.230; .233; .229; .225; .229; .232 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00719706). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.