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L-Carnosine for Bipolar I Disorder

NCT00177463 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2016-01-11

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Alliance for Research on Schizophrenia and Depression

    collaborator OTHER

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • K.N. Roy Chengappa, MD · Western Psychiatric Institute and Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00177463 on ClinicalTrials.gov