L-Carnosine for Bipolar I Disorder
Completed · Not applicable · Has a placebo group
Conditions studied: Bipolar I Disorder
In brief
Our 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. Secondarily, we hypothesize there will be secondary improvements in positive, negative and mood symptoms with L-carnosine treatment. We 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. Measures of cognition, and psychopathology will be utilized for evaluating primary and secondary outcomes, along with safety assessments.
Key facts
- Study ID
- NCT00177463
- Run by
- University of Pittsburgh
- People needed
- 47
- Starts
- 2004-09-01
- Expected to finish
- 2007-12-01
- Last updated by the study team
- 2016-01-11
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Ability to provide informed, competent and written consent
- Current medication and mood status (Y-MRS and MADRS scores less than or equal to 10) is stable for greater than or equal to 4 weeks.
You may not qualify if…
- 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
- Pregnant or lactating women
- Mini-mental state examination score (MMSE) less than or equal to 23.
Where it is running
- Mayview State Hospital — Bridgeville, Pennsylvania, United States
- Mon-Yough Community Services, Inc. — McKeesport, Pennsylvania, United States
- Western Psychiatric Institute and Clinic — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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