L-Carnosine for Bipolar I Disorder

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: National Alliance for Research on Schizophrenia and Depression
• Treatments: Antioxidants

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.