Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00177177
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2005-09-12
Brief Title:
L-carnosine for Schizophrenia
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 schizophreniaschizoaffective 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
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 schizophreniaschizoaffective 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
Detailed Description:
OBJECTIVE
Based on the available neuroscience and human data we hypothesize that supplemental L-carnosine treatment a potent naturally occuring antioxidant and anti-glycation agent will be a useful disease modifying agent when used adjunctively with antipsychotic drugs in patients with a diagnosis of either schizophrenia or schizoaffective disorder More specifically 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 schizophrenia or schizoaffective disorder Secondarily we hypothesize there will be secondary improvements in positive negative and mood symptoms with L-carnosine treatment
RESEARCH PLAN
A randomized placebo controlled add-on treatment trial of L-carnosine added to existing antipsychotic treatment for a period of 16 weeks Measures of cognition and psychopathology will be utilized for evaluating primary and secondary outcomes along with safety assessments
METHODS
Up to eighty-four subjects with DSM-IV-TR schizophreniaschizoaffective disorder will be recruited from Western Psychiatric Institute and Clinic Mayview State Hospital Mon Yough Community Services Inc and Dubois Regional Medical Center using a 11 randomization subjects who sign a informed consent document will be randomized to receive L-carnosine or placebo During a 4 week titration period the L-carnosine dosage will be increased from 500 to 2000 mgday and continued for an additional 8 weeks If side-effects are noted a minimum of 500 mgday of L-carnosine can be used
A computerized cognitive battery will form the main efficacy measures and be administered at baseline and at visit 6 ie just prior to the 4 week taper some of these measures will be administered at visit 4 28 days Standard psychopathology rating scales will be administered to evaluate secondary aims such as impact on positive and negative symptoms of schizophrenia 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 bringing subjects in for assessments outside the scheduled visits
SIGNIFICANCE
Cognitive dysfunction in persons with schizophrenia is a serious limitation to achieving significantly better functional outcomes Green et al 1996 Till recently therapeutic nihilism prevailed when it came to treatments that improve cognitive abilities in schizophrenia One reason for this pessimistic view was that cognitive dysfunction was not considered to be malleable to treatment but instead was thought to represent an unchanging dimension of the illness However that view is now changing and psychosocial and cognitive remediation techniques are being evaluated to treat cognitive dysfunction in schizophrenia A recent synthesis of data would suggest that mediators of a better cognitive outcome may also include agents that target the inefficient antioxidant defenses in persons with schizophrenia or those that counter NMDA-glutamate neuronal excitotoxicity Yao et al 2001 These mechanisms may underlie the neuronal membrane pathology in schizophrenia and in turn these abnormalities may contribute to the cognitive dysfunction and decline reported during the course of the illness The benefits of L-carnosine a naturally occurring antioxidant and anti-glycation agent for improved cognitive abilities and in social behavior and communicative skills were reported in a random-assignment double-blind placebo-controlled trial in children and adolescents with autism specifically improvements in receptive language scores and socialization and communication skill scores Chez et al 2002a
The primary focus of this study is to evaluate the ability of L-carnosine a naturally occurring dipeptide to enhance cognitive abilities in people with schizophrenia The study will also evaluate whether L-carnosine has secondary benefits for positive and negative and mood symptoms As a relatively benign agent L-carnosine offers the potential to achieve a significant clinical impact in improving cognitive dysfunction in persons with schizophrenia if efficacy is confirmed
Based on the available neuroscience and human data we hypothesize that supplemental L-carnosine treatment a potent naturally occuring antioxidant and anti-glycation agent will be a useful disease modifying agent when used adjunctively with antipsychotic drugs in patients with a diagnosis of either schizophrenia or schizoaffective disorder More specifically 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 schizophrenia or schizoaffective disorder Secondarily we hypothesize there will be secondary improvements in positive negative and mood symptoms with L-carnosine treatment
RESEARCH PLAN
A randomized placebo controlled add-on treatment trial of L-carnosine added to existing antipsychotic treatment for a period of 16 weeks Measures of cognition and psychopathology will be utilized for evaluating primary and secondary outcomes along with safety assessments
METHODS
Up to eighty-four subjects with DSM-IV-TR schizophreniaschizoaffective disorder will be recruited from Western Psychiatric Institute and Clinic Mayview State Hospital Mon Yough Community Services Inc and Dubois Regional Medical Center using a 11 randomization subjects who sign a informed consent document will be randomized to receive L-carnosine or placebo During a 4 week titration period the L-carnosine dosage will be increased from 500 to 2000 mgday and continued for an additional 8 weeks If side-effects are noted a minimum of 500 mgday of L-carnosine can be used
A computerized cognitive battery will form the main efficacy measures and be administered at baseline and at visit 6 ie just prior to the 4 week taper some of these measures will be administered at visit 4 28 days Standard psychopathology rating scales will be administered to evaluate secondary aims such as impact on positive and negative symptoms of schizophrenia 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 bringing subjects in for assessments outside the scheduled visits
SIGNIFICANCE
Cognitive dysfunction in persons with schizophrenia is a serious limitation to achieving significantly better functional outcomes Green et al 1996 Till recently therapeutic nihilism prevailed when it came to treatments that improve cognitive abilities in schizophrenia One reason for this pessimistic view was that cognitive dysfunction was not considered to be malleable to treatment but instead was thought to represent an unchanging dimension of the illness However that view is now changing and psychosocial and cognitive remediation techniques are being evaluated to treat cognitive dysfunction in schizophrenia A recent synthesis of data would suggest that mediators of a better cognitive outcome may also include agents that target the inefficient antioxidant defenses in persons with schizophrenia or those that counter NMDA-glutamate neuronal excitotoxicity Yao et al 2001 These mechanisms may underlie the neuronal membrane pathology in schizophrenia and in turn these abnormalities may contribute to the cognitive dysfunction and decline reported during the course of the illness The benefits of L-carnosine a naturally occurring antioxidant and anti-glycation agent for improved cognitive abilities and in social behavior and communicative skills were reported in a random-assignment double-blind placebo-controlled trial in children and adolescents with autism specifically improvements in receptive language scores and socialization and communication skill scores Chez et al 2002a
The primary focus of this study is to evaluate the ability of L-carnosine a naturally occurring dipeptide to enhance cognitive abilities in people with schizophrenia The study will also evaluate whether L-carnosine has secondary benefits for positive and negative and mood symptoms As a relatively benign agent L-carnosine offers the potential to achieve a significant clinical impact in improving cognitive dysfunction in persons with schizophrenia if efficacy is confirmed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB 0408179 | None | None | None |