NCT00177177

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Mar 2004

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

3.7 years

First QC Date

September 12, 2005

Last Update Submit

January 15, 2013

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

L-carnosineSchizophreniaSchizoaffective disorderCognitive enhancement

Outcome Measures

Primary Outcomes (2)

  • To see if oral L-carnosine treatment (as compared with placebo) will enhance cognitive abilities (as noted below)

    12 weeks treatment

  • executive function, working memory, attention, visuospatial ability

    12 weeks treatment

Secondary Outcomes (1)

  • To examine if secondary improvements in positive, negative and mood symptoms occur with L-carnosine treatment

    12 weeks treatment

Study Arms (2)

1

EXPERIMENTAL

L Carnosine

Drug: L-carnosine (dietary supplement)

2

PLACEBO COMPARATOR

Placebo

Drug: L-carnosine (dietary supplement)

Interventions

L-carnosine (dietary supplement)DRUG

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

Also known as: L Carnosine, Placebo
12

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • th 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Mayview State Hospital

Bridgeville, Pennsylvania, 15107-1599, United States

Location

Dubois Regional Medical Center

DuBois, Pennsylvania, 15801, United States

Location

Mon-Yough Community Services, Inc.

McKeesport, Pennsylvania, 15132, United States

Location

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Chengappa KN, Turkin SR, DeSanti S, Bowie CR, Brar JS, Schlicht PJ, Murphy SL, Hetrick ML, Bilder R, Fleet D. A preliminary, randomized, double-blind, placebo-controlled trial of L-carnosine to improve cognition in schizophrenia. Schizophr Res. 2012 Dec;142(1-3):145-52. doi: 10.1016/j.schres.2012.10.001. Epub 2012 Oct 23.

    PMID: 23099060RESULT

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

CarnosineDietary Supplements

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

NeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsDipeptidesOligopeptidesNerve Tissue ProteinsProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • K.N. Roy Chengappa, MD

    Western Psychiatric Institute and Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

March 1, 2004

Primary Completion

November 1, 2007

Study Completion

December 1, 2007

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(4)