L-Carnosine for Bipolar I Disorder

18:53 EDT 25th October 2014 | BioPortfolio

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.

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 1:1 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 inclusion/exclusion 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 (attention/executive 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 mg/day, increasing each week by 500 mg to a dose of 2000 mg/day (twice daily schedule) in 4 weeks; as an adjunct to existing psychotropic medicines. The dose of 2000 mg (or less, i.e. 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 Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Bipolar I Disorder

Intervention

L-carnosine

Location

Mayview State Hospital
Bridgeville
Pennsylvania
United States
15017

Status

Completed

Source

University of Pittsburgh

Results (where available)

View Results

Links

Clinical Trials [575 Associated Clinical Trials listed on BioPortfolio]

Pharmacokinetics of Carnosine

The absorption kinetics of dietary carnosine (β-alanyl-L-histidine) will be determined in the healthy adults.

Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar Disorder

The main objective of this study is to assess the effectiveness and safety of lamotrigine in the treatment of youth with bipolar and bipolar spectrum disorder. This is an exploratory, 12-w...

Effect of Carnosine on Diabetes and Cardiovascular Risk Factors

Carnosine is a naturally occurring compound with a potential health benefits. In animal studies, carnosine supplementation reduces manifestation of chronic civilization diseases, regulates...

Bipolar Disorder in Late Life

The purpose of this study is to look at certain structural changes in the brain in people with bipolar disorder or those with a history of Bipolar disorder. Also collecting a blood sample...

Equetro for the Treatment of Mania in Children Ages 6-12 With Bipolar Disorder

This is an open-label pilot study of up to 1200 mg/day of carbamazepine ER (Equetro) in the treatment of children who meet DSM-IV criteria for Bipolar I, Bipolar II, or Bipolar Spectrum Di...

PubMed Articles [4372 Associated PubMed Articles listed on BioPortfolio]

Differential diagnosis of unipolar vs bipolar depression.

Bipolar depression is commonly misdiagnosed as unipolar depression, which can be detrimental to the patient. Two effective and valuable screening tools to help accurately diagnose bipolar disorder and...

Bipolar disorder and DSM-5: Still far from the disease.

Although bipolar disorder is highly disabling, data from different regions of the world agree on the finding that there is a prolonged diagnostic delay in affected people. Among the main factors that ...

Evaluating the missing heritability of bipolar disorder using the multifactorial liability threshold model.

In order to evaluate the missing heritability of bipolar disorder, we queried the GWAS catalog of National Human Genome Research Institute, retrieve all the susceptible gene variation of bipolar disor...

Oxidative stress in bipolar affective disorder.

The results of mortality studies have indicated that medical conditions, such as cardiovascular disease, obesity and diabetes are the most important causes of mortality among patients with bipolar dis...

Bipolar Disorder in Children With ADHD: A Clinical Sample Study.

To explore the impact of early-onset bipolar disorder (pediatric bipolar disorder [PBD]) on ADHD.

Medical and Biotech [MESH] Definitions

A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence.

An amino acid formed in vivo by the degradation of dihydrouracil and carnosine. Since neuronal uptake and neuronal receptor sensitivity to beta-alanine have been demonstrated, the compound may be a false transmitter replacing GAMMA-AMINOBUTYRIC ACID. A rare genetic disorder, hyper-beta-alaninemia, has been reported.

An element in the alkali metals family. It has the atomic symbol Li, atomic number 3, and atomic weight 6.94. Salts of lithium are used in treating BIPOLAR DISORDER.

INTERNEURONS of the vertebrate RETINA containing two processes. They receive inputs from the RETINAL PHOTORECEPTOR CELLS and send outputs to the RETINAL GANGLION CELLS. The bipolar cells also make lateral connections in the retina with the RETINAL HORIZONTAL CELLS and with the AMACRINE CELLS.

A naturally occurring dipeptide neuropeptide found in muscles.

More From BioPortfolio on "L-Carnosine for Bipolar I Disorder"

Search BioPortfolio:
Loading
Advertisement

Relevant Topic

Psychiatry
Latest News Clinical Trials Research Drugs Reports Corporate
Psychiatry is the study of mental disorders and their diagnosis, management and prevention.  Conditions include schizophrenia, severe depression and panic disorders among others. There are pharmaceutical treatments as well as other therapies to help...

Advertisement