Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00177463
Status:
COMPLETED
Last Update Posted:
2016-01-11
First Post:
2005-09-12
Brief Title:
L-Carnosine for Bipolar I Disorder
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Pilot Add-on Randomized Placebo Controlled Intervention Trial of Cognitive Enhancement in Persons With Bipolar Disorder Using an Antioxidant and Advanced Glycation End AGE Product Inhibitor L-Carnosine
Status:
COMPLETED
Status Verified Date:
2016-01
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:
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
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
Detailed Description:
OBJECTIVE
It is our hypothesis that L-carnosine treatment of persons with bipolar illness will improve their cognitive outcomes more specifically measures of attention and executive function verbal and visuospatial memory and psychomotor performance relative to placebo treatment We also hypothesize that L-carnosine treatment may secondarily improve any residual affective symptoms
RESEARCH PLAN
We aim to test these hypotheses by conducting a randomized placebo controlled add on treatment trial of L-carnosine added to ongoing prescribed pharmacological treatment for example - lithium anticonvulsants antipsychotic agents and depressants for a period of 12 weeks Measures of cognition and psychopathology will be utilized for evaluating primary and secondary outcomes along with safety assessments
METHODS
Up to 48 subjects with DSM IV TR bipolar I disorder will be recruited from Western Psychiatric Institute and Clinic Mayview State Hospital and Mon Yough Community Services Inc using a 11 randomization subjects who sign a informed consent document will be randomized to receive L-carnosine or placebo
It is expected that 12 of the 48 subjects may not meet inclusionexclusion criteria leaving 36 consenting adults 18 to 65 years with DSM IV-TR Bipolar Disorder who will be assessed for euthymia Young Mania Rating Scale Score 10 Montgomery Asberg Depression Rating Scale Score of 10 over a one month period 2 assessments while receiving stable doses of their current medications They will also be assessed for cognitive dysfunction attentionexecutive function immediate and declarative memory and psychomotor performance using Cogtest - a proprietary neuropsychological library of 19 tests These subjects will be characterized for normal pre-morbid IQ no ECT treatment in past 6 months no alcohol or substance dependence in past 6 months mini-mental state score 24
L-carnosine or placebo will be administered using random assignment at a dose of 500 mgday increasing each week by 500 mg to a dose of 2000 mgday twice daily schedule in 4 weeks as an adjunct to existing psychotropic medicines The dose of 2000 mg or less ie a minimum of 500 mg if tolerability is an issue will be continued for 8 additional weeks L-carnosine is not known to have interactions with psychotropic drugs but mood-stabilizer levels will be monitored
Standard psychopathology rating scales will be administered to evaluate secondary aims such as impact on residual symptoms of bipolar disorder 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 bring subjects in for assessments outside the scheduled visits and by telephone contact in between longer scheduled visits
SIGNIFICANCE
Cognitive dysfunction can seriously hinder improved functional outcomes in persons with schizophrenia or bipolar disorder If this short term intervention with L-carnosine shows promise more definitive studies using adequate powered sample sizes and of longer duration can be conducted If improvements in cognitive problems are linked to improved functional outcomes using such supplemental treatments an important therapeutic milestone in bipolar disorder will have been achieved
It is our hypothesis that L-carnosine treatment of persons with bipolar illness will improve their cognitive outcomes more specifically measures of attention and executive function verbal and visuospatial memory and psychomotor performance relative to placebo treatment We also hypothesize that L-carnosine treatment may secondarily improve any residual affective symptoms
RESEARCH PLAN
We aim to test these hypotheses by conducting a randomized placebo controlled add on treatment trial of L-carnosine added to ongoing prescribed pharmacological treatment for example - lithium anticonvulsants antipsychotic agents and depressants for a period of 12 weeks Measures of cognition and psychopathology will be utilized for evaluating primary and secondary outcomes along with safety assessments
METHODS
Up to 48 subjects with DSM IV TR bipolar I disorder will be recruited from Western Psychiatric Institute and Clinic Mayview State Hospital and Mon Yough Community Services Inc using a 11 randomization subjects who sign a informed consent document will be randomized to receive L-carnosine or placebo
It is expected that 12 of the 48 subjects may not meet inclusionexclusion criteria leaving 36 consenting adults 18 to 65 years with DSM IV-TR Bipolar Disorder who will be assessed for euthymia Young Mania Rating Scale Score 10 Montgomery Asberg Depression Rating Scale Score of 10 over a one month period 2 assessments while receiving stable doses of their current medications They will also be assessed for cognitive dysfunction attentionexecutive function immediate and declarative memory and psychomotor performance using Cogtest - a proprietary neuropsychological library of 19 tests These subjects will be characterized for normal pre-morbid IQ no ECT treatment in past 6 months no alcohol or substance dependence in past 6 months mini-mental state score 24
L-carnosine or placebo will be administered using random assignment at a dose of 500 mgday increasing each week by 500 mg to a dose of 2000 mgday twice daily schedule in 4 weeks as an adjunct to existing psychotropic medicines The dose of 2000 mg or less ie a minimum of 500 mg if tolerability is an issue will be continued for 8 additional weeks L-carnosine is not known to have interactions with psychotropic drugs but mood-stabilizer levels will be monitored
Standard psychopathology rating scales will be administered to evaluate secondary aims such as impact on residual symptoms of bipolar disorder 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 bring subjects in for assessments outside the scheduled visits and by telephone contact in between longer scheduled visits
SIGNIFICANCE
Cognitive dysfunction can seriously hinder improved functional outcomes in persons with schizophrenia or bipolar disorder If this short term intervention with L-carnosine shows promise more definitive studies using adequate powered sample sizes and of longer duration can be conducted If improvements in cognitive problems are linked to improved functional outcomes using such supplemental treatments an important therapeutic milestone in bipolar disorder will have been achieved
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 0410144 | None | None | None |