Bipolar I Disorder Clinical Trial
Official title:
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
Verified date | January 2016 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 47 |
Est. completion date | December 2007 |
Est. primary completion date | December 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mayview State Hospital | Bridgeville | Pennsylvania |
United States | Mon-Yough Community Services, Inc. | McKeesport | Pennsylvania |
United States | Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | National Alliance for Research on Schizophrenia and Depression |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | That L-carnosine treatment of persons with bipolar illness will improve their cognitive outcomes, specifically, measures of attention and executive function, verbal and visuospatial memory and psychomotor performance, relative to placebo treatment. | 12 weeks treatment | No | |
Secondary | That L-carnosine treatment may secondarily improve any residual affective symptoms in subjects with bipolar disorder. | 12 weeks treatment | No |
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