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L-Carnosine for Bipolar I Disorder

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177463
First received: September 12, 2005
Last updated: September 24, 2009
Last verified: February 2008
  Purpose

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.


Condition Intervention
Bipolar I Disorder
Dietary Supplement: L-carnosine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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. [ Time Frame: 12 weeks treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • That L-carnosine treatment may secondarily improve any residual affective symptoms in subjects with bipolar disorder. [ Time Frame: 12 weeks treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: September 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
L Carnosine
Dietary Supplement: L-carnosine
an antioxidant and AGE inhibitor, 500 mg/day, increasing each week in titration reaching 2000 mg/day in 4 weeks and maintained for rest of trial
Other Names:
  • L Carnosine
  • Placebo
Placebo Comparator: 2
Placebo
Dietary Supplement: L-carnosine
an antioxidant and AGE inhibitor, 500 mg/day, increasing each week in titration reaching 2000 mg/day in 4 weeks and maintained for rest of trial
Other Names:
  • L Carnosine
  • Placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177463

Locations
United States, Pennsylvania
Mayview State Hospital
Bridgeville, Pennsylvania, United States, 15017
Mon-Yough Community Services, Inc.
McKeesport, Pennsylvania, United States, 15132
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: K.N. Roy Chengappa, MD Western Psychiatric Institute and Clinic
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00177463     History of Changes
Other Study ID Numbers: Chengappa L-carnosine, IRB #0410144
Study First Received: September 12, 2005
Last Updated: September 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
L-carnosine
Bipolar I disorder
Cognitive enhancement

Additional relevant MeSH terms:
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014