Bipolar Disorder: A Pilot Add-on Randomized, Placebo Controlled Intervention Trial of Cognitive Enhancement in Persons with Bipolar Disorder Using an Antioxidant and Advanced Glycation End (AGE) Product Inhibitor: L-Carnosine

Contact name: Patricia Schlicht

Phone: (412)-246-5258

Fax: (412)-246-6116

Email: schlichtp@upmc.edu

Disorder: Bipolar

Geographic location: Pittsburgh, PA

Other keywords: Carnosine, nutritional supplement, cognition

Participant compensation: reimbursed up to $150 for completion of the study

Time commitment required: 12 weeks

Drug trial: Yes

Recruitment end date (approximate): October 26, 2005

Study criteria (i.e., age or gender requirements):
1) DSM IV – TR diagnosis of bipolar I disorder or; 2) Ages 18 to 60 years; 3) Men or Women; 4) Ability to read and communicate in English; 5) 8th grade education or greater; 6) Ability to provide informed, competent and written consent; 7) Current medication and mood status is stable for greater than or equal to 4 weeks.

Exclusion criteria:
1) Medically unstable conditions; 2) Known allergy to L-carnosine; 3) Current cognitive decline is attributable to a diagnosis of dementia or other neurological disorder, including HIV dementia or cognitive decline; 4) Pregnant or lactating women; 5) Mini-mental state examination score (MMSE) less than or equal to 23.

Brief description of study:
We will recruit thirty-six male or female subjects, aged 18-60 years, to study the effectiveness of a nutritional supplement - L-carnosine to improve cognitive abilities (concentration, attention, judgement, and memory) in persons with bipolar disorder. L-carnosine is a nutritional supplement that is sold over the counter in nutritional stores, however the use of L-carnosine in this study is investigational (not FDA approved for bipolar disorder). As L-carnosine has not been used in subjects with bipolar disorder, we will also evaluate the safety and tolerability of adding L-carnosine to standard treatments for persons with bipolar disorder.The purposes of this study are to determine, whether L-carnosine can improve cognitive abilities (concentration, attention, judgment, and memory) in people with bipolar disorder, and whether L-carnosine is safe to add to standard treatment for bipolar disorder.

Additional information:
2nd Research coordinator: Carrie Heasley, email: heasleyca@upmc.edu.
Office Assistant for group: Erin List, Phone: 412-246-5261, email: listel@upmc.edu