L-Carnosine for Bipolar I Disorder

What Was Tested

This registered not phased trial tested Carnosine.

Their hypothesis is that oral L-carnosine treatment (as compared with placebo) will enhance cognitive abilities (specifically: measures of attention, executive function, working memory, visuospatial ability and language) in persons with bipolar disorder.

The researchers aim to test these hypotheses by conducting a randomized, placebo controlled, add on treatment trial of L-carnosine (added to existing antipsychotic treatment) on 48 recruited subjects with DSM IV TR bipolar disorder for a period of 12 weeks.

It had two arms (groups): L- Carnosine (experimental) and Placebo (placebo comparator).

Placebo.

The registry classes the interventions as drug.

More on the Plan

They will also be assessed for cognitive dysfunction (attention/executive function, immediate and declarative memory, and psychomotor performance) using Cogtest - a proprietary neuropsychological library of 19 tests.

These subjects will be characterized for normal pre-morbid IQ, no ECT treatment in past 6 months, no alcohol or substance dependence in past 6 months, mini-mental state score ≥ 24.

L-carnosine is not known to have interactions with psychotropic drugs but mood-stabilizer levels will be monitored.

Standard psychopathology rating scales will be administered to evaluate secondary aims such as impact on residual symptoms of bipolar disorder.

Who Took Part

47 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: DSM IV - TR diagnosis of bipolar I disorder or. Ages 18 to 65 years. Men or Women. Ability to read and communicate in English. 8th grade education or greater.

The full record lists 7 inclusion and 5 exclusion criteria; among the exclusions: medically unstable conditions; known allergy to l-carnosine; current cognitive decline is attributable to a diagnosis of dementia or other neurological disorder, including hiv dementia or cognitive decline.

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 Carnosine and who got the comparison, which limits bias.

The Carnosine group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Carnosine, so expectations could not easily colour the readings.

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

It started in 2004-09 with completion listed for 2007-12.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Carnosine in 47 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Carnosine compound page, all human trials.