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L-carnosine for Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177177
First received: September 12, 2005
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

The investigators' 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 schizophrenia or schizoaffective disorder. Secondarily, they hypothesize that there will be secondary improvements in positive, negative and mood symptoms with L-carnosine treatment.

The investigators aim to test these hypotheses by conducting a randomized, placebo controlled, add-on treatment trial of L-carnosine (added to existing antipsychotic treatment) up to 84 recruited subjects with Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) schizophrenia/schizoaffective disorder for a period of 16 weeks. Measures of cognition and psychopathology will be utilized for evaluating primary and secondary outcomes, along with safety assessments.


Condition Intervention
Schizophrenia
Schizoaffective Disorder
 Drug: L-carnosine (dietary supplement)

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: L-Carnosine, an Antioxidant and AGE Inhibitor (Advanced Glycation End Products) for Cognitive Enhancement Among Persons With Schizophrenia: A Randomized, Add-on Double-Blind, Placebo Controlled, Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • To see if oral L-carnosine treatment (as compared with placebo) will enhance cognitive abilities (as noted below) [ Time Frame: 12 weeks treatment ] [ Designated as safety issue: No ]
  • executive function, working memory, attention, visuospatial ability [ Time Frame: 12 weeks treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To examine if secondary improvements in positive, negative and mood symptoms occur with L-carnosine treatment [ Time Frame: 12 weeks treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: March 2004
Study Completion Date: December 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
L Carnosine
 Drug: L-carnosine (dietary supplement)
an antioxidant and AGE inhibitor, 500 mg/day, titration each week to reach 2000 mg/day in 4 weeks L-Carnosine is a dietary supplement
Other Names:
  • L Carnosine
  • Placebo
Placebo Comparator: 2
Placebo
 Drug: L-carnosine (dietary supplement)
an antioxidant and AGE inhibitor, 500 mg/day, titration each week to reach 2000 mg/day in 4 weeks L-Carnosine is a dietary supplement
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 schizophrenia (any subtype, except currently catatonic) or schizoaffective disorder
  • 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 antipsychotic medication 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
  • Pregnant or lactating women
  • Mini-mental state examination score (MMSE) less than or equal to 23
  • HIV positive status resulting in AIDS-related dementia.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00177177

Locations
United States, Pennsylvania
Mayview State Hospital
Bridgeville, Pennsylvania, United States, 15107-1599
Dubois Regional Medical Center
Dubois, Pennsylvania, United States, 15801
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
Stanley Medical Research Institute
Investigators
Principal Investigator: K.N. Roy Chengappa, MD Western Psychiatric Institute and Clinic
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00177177     History of Changes
Other Study ID Numbers: 03T-413, IRB #0408179
Study First Received: September 12, 2005
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
L-carnosine
Schizophrenia
Schizoaffective disorder
Cognitive enhancement

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antioxidants
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013