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L-Carnosine for Bipolar I Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00177463
First Posted: September 15, 2005
Last Update Posted: January 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
K.N. Roy Chengappa, University of Pittsburgh
  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 Drug: L-carnosine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 K.N. Roy Chengappa, 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 ]

Secondary Outcome Measures:
  • That L-carnosine treatment may secondarily improve any residual affective symptoms in subjects with bipolar disorder. [ Time Frame: 12 weeks treatment ]

Enrollment: 47
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: 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
Drug: 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 Name: L Carnosine
Placebo Comparator: Placebo
Placebo
Drug: 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 Name: L Carnosine

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: K.N. Roy Chengappa, Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177463     History of Changes
Other Study ID Numbers: Chengappa L-carnosine
IRB #0410144
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: January 11, 2016
Last Verified: January 2016

Keywords provided by K.N. Roy Chengappa, University of Pittsburgh:
L-carnosine
Bipolar I disorder
Cognitive enhancement

Additional relevant MeSH terms:
Disease
Pathologic Processes
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs