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Phase 2 N=40 Randomized Quadruple-blind Treatment

The Use of a Mitochondrial Enhancement Treatment in Bipolar Disorder

Bipolar Depression

Bottom Line

View on ClinicalTrials.gov: NCT00719706 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcome: Primary: The 25-Item Hamilton Depression Rating Scale. — 23.3; 22.1; 17.5; 18.5 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
acetyl-l-carnitine PLUS alpha-lipoic acide (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Mclean Hospital
Primary completion
May 2011

Outcome Measures

OutcomeResultp-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 —

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.

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.
View full record on ClinicalTrials.gov →

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.

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