NCT00177463

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

3 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

September 1, 2004

Completed
1 year 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
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

January 11, 2016

Status Verified

January 1, 2016

Enrollment Period

3.2 years

First QC Date

September 12, 2005

Last Update Submit

January 7, 2016

Conditions

Bipolar I Disorder

Keywords

L-carnosineBipolar I disorderCognitive enhancement

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks treatment

Secondary Outcomes (1)

  • That L-carnosine treatment may secondarily improve any residual affective symptoms in subjects with bipolar disorder.

    12 weeks treatment

Study Arms (2)

L- Carnosine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo

Drug: L-carnosine

Interventions

L-carnosineDRUG

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

Also known as: L Carnosine
L- CarnosinePlacebo

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 bipolar I disorder or
  • 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 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.

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, including HIV dementia or cognitive decline
  • Pregnant or lactating women
  • Mini-mental state examination score (MMSE) less than or equal to 23.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mayview State Hospital

Bridgeville, Pennsylvania, 15017, 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 Links

MeSH Terms

Interventions

Carnosine

Intervention Hierarchy (Ancestors)

NeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsDipeptidesOligopeptidesNerve Tissue ProteinsProteins

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
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

September 1, 2004

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

January 11, 2016

Record last verified: 2016-01

Locations

US(3)