L-carnosine for Schizophrenia

What Was Tested

The trial (not phased) is built around Carnosine.

The investigators' 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 schizophrenia or schizoaffective disorder.

The investigators aim to test these hypotheses by conducting a randomized, placebo controlled, add-on treatment trial of L-carnosine (added to existing antipsychotic treatment) up to 84 recruited subjects with Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) schizophrenia/schizoaffective disorder for a period of 16 weeks.

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

L Carnosine.

Placebo.

The registry classes the interventions as drug.

More on the Plan

More specifically, 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 schizophrenia or schizoaffective disorder.

Measures of cognition, and psychopathology will be utilized for evaluating primary and secondary outcomes, along with safety assessments.

Standard psychopathology rating scales will be administered to evaluate secondary aims such as impact on positive and negative symptoms of schizophrenia.

Any adverse effects will be assessed by asking questions at each visit, and if required bringing subjects in for assessments outside the scheduled visits.

Who Took Part

The registry lists 84 planned participants were the target.

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 schizophrenia (any subtype, except currently catatonic) or schizoaffective disorder. 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 6 exclusion criteria; among the exclusions: known allergy to l-carnosine; current cognitive decline is attributable to a diagnosis of dementia or other neurological disorder; pregnant or lactating women.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this Carnosine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

As a double-blind Carnosine study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2004-03 with completion listed for 2007-11.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: To see if oral L-carnosine treatment (as compared with placebo) will enhance cognitive abilities (as noted below) (time frame: 12 weeks treatment). executive function, working memory, attention, visuospatial ability (time frame: 12 weeks treatment).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Carnosine in 84 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.