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L-Carnosine for Bipolar I Disorder

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ClinicalTrials.gov Identifier: NCT00177463
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : January 11, 2016
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
K.N. Roy Chengappa, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 15, 2005
Last Update Posted Date January 11, 2016
Study Start Date  ICMJE September 2004
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
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.
Change History Complete list of historical versions of study NCT00177463 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2008)
That L-carnosine treatment may secondarily improve any residual affective symptoms in subjects with bipolar disorder. [ Time Frame: 12 weeks treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
That L-carnosine treatment may secondarily improve any residual affective symptoms in subjects with bipolar disorder.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE L-Carnosine for Bipolar I Disorder
Official Title  ICMJE 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
Brief 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.

Detailed Description

OBJECTIVE:

It is our hypothesis that L-carnosine treatment of persons with bipolar illness will improve their cognitive outcomes, more specifically, measures of attention and executive function, verbal and visuospatial memory and psychomotor performance, relative to placebo treatment. We also hypothesize that L-carnosine treatment may secondarily improve any residual affective symptoms.

RESEARCH PLAN:

We aim to test these hypotheses by conducting a randomized, placebo controlled, add on treatment trial of L-carnosine (added to ongoing prescribed pharmacological treatment, for example - lithium, anticonvulsants, antipsychotic agents and depressants) for a period of 12 weeks. Measures of cognition, and psychopathology will be utilized for evaluating primary and secondary outcomes, along with safety assessments.

METHODS:

Up to 48 subjects with DSM IV TR bipolar I disorder will be recruited from Western Psychiatric Institute and Clinic, Mayview State Hospital and Mon Yough Community Services, Inc. using a 1:1 randomization, subjects who sign a informed consent document will be randomized to receive L-carnosine or placebo.

It is expected that 12 of the 48 subjects may not meet inclusion/exclusion criteria, leaving 36 consenting adults (18 to 65 years) with DSM IV-TR Bipolar Disorder who will be assessed for euthymia (Young Mania Rating Scale Score ≤ 10, Montgomery Asberg Depression Rating Scale Score of ≤ 10) over a one month period (2 assessments) while receiving stable doses of their current medications. They will also be assessed for cognitive dysfunction (attention/executive function, immediate and declarative memory, and psychomotor performance) using Cogtest - a proprietary neuropsychological library of 19 tests. These subjects will be characterized for normal pre-morbid IQ, no ECT treatment in past 6 months, no alcohol or substance dependence in past 6 months, mini-mental state score ≥ 24.

L-carnosine (or placebo) will be administered using random assignment at a dose of 500 mg/day, increasing each week by 500 mg to a dose of 2000 mg/day (twice daily schedule) in 4 weeks; as an adjunct to existing psychotropic medicines. The dose of 2000 mg (or less, i.e. a minimum of 500 mg if tolerability is an issue) will be continued for 8 additional weeks. L-carnosine is not known to have interactions with psychotropic drugs but mood-stabilizer levels will be monitored.

Standard psychopathology rating scales will be administered to evaluate secondary aims such as impact on residual symptoms of bipolar disorder. Safety will be assessed by tailing a careful medical history and physical examination at screening and evaluating results of laboratory measures. Any adverse effects will be assessed by asking questions at each visit, and if required bring subjects in for assessments outside the scheduled visits, and by telephone contact in between longer scheduled visits.

SIGNIFICANCE:

Cognitive dysfunction can seriously hinder improved functional outcomes in persons with schizophrenia or bipolar disorder. If this short term intervention with L-carnosine shows promise, more definitive studies using adequate powered sample sizes, and of longer duration can be conducted. If improvements in cognitive problems are linked to improved functional outcomes using such supplemental treatments, an important therapeutic milestone in bipolar disorder will have been achieved.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bipolar I Disorder
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: L-carnosine
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: L-carnosine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 7, 2016)
47
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
36
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00177463
Other Study ID Numbers  ICMJE Chengappa L-carnosine
IRB #0410144
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party K.N. Roy Chengappa, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE National Alliance for Research on Schizophrenia and Depression
Investigators  ICMJE
Principal Investigator: K.N. Roy Chengappa, MD Western Psychiatric Institute and Clinic
PRS Account University of Pittsburgh
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP