The Use of a Mitochondrial Enhancement Treatment in Bipolar Disorder

What Was Tested

The trial (phase 2) is built around L-Carnitine.

It had two arms (groups): 1 (active comparator) and 2 (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 40 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got L-Carnitine and who got the comparison, which limits bias.

The L-Carnitine group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received L-Carnitine.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2008-08 with completion listed for 2011-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The 25-Item Hamilton Depression Rating Scale (time frame: Baseline to 15 Weeks). The Montgomery-Asberg Depression Rating Scale (time frame: Baseline to 15 weeks). The Young Mania Rating Scale (time frame: Baseline to 15 weeks).

It also tracked 1 secondary outcome, for example Phosphorus MRS Scans on 4T Scanner.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of L-Carnitine in 40 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the L-Carnitine compound page, all human trials.