Valproic Acid Sodium Salt in Bipolar Disorder - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00431522

Purpose

To determine the total and local gray matter volumes, and N-acetyl aspartate (NAA) levels in patients with bipolar disorders who are within euthimic, depressive or manic/hypomanic period and who are not taking drug;
To investigate the neuroprotective effects of long-term (6 weeks) use of valproate on total and local gray matter volumes and NAA levels.
To measure the brain electrical response to visual and auditory impulses before and after valproate treatment in patients within euthimic, depressive or manic/hypomanic period and who are not taking drug, and to compare the data with each other and with normal groups.
To determine the cognitive functions before and after the valproate treatment in the same patient group, to compare the data with each other and with age- and sex-paired normal controls;
To determine the relationship between these effects of valproate and clinical improvement;
To investigate the relationship between cognitive ability status and electrical activity of brain, to compare this with that in control group; to determine the relationship between the data and brain imaging (MRI/MRS) findings in conjunction with localization

Condition	Intervention	Phase
Bipolar Disorder	Drug: Valproic acid, sodium salt	Phase IV

MedlinePlus related topics: Bipolar Disorder Dietary Sodium

Drug Information available for: Sodium chloride Divalproex sodium Valproate Sodium Valproic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Factorial Assignment, Safety/Efficacy Study
Official Title:	Protective Effect of Valproate on Brain Cells:A Magnetic Resonance Imaging and Spectroscopy Study in Patients With Bipolar Disorder Diagnosis

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Measuring total brain gray matter and white matter volumes, cingulated volume, dorsolateral prefrontal cortex N-acetyl aspartate (NAA) concentrations with spectroscopic MRI both for study(n=30) and control(n=30) group.
Calculating young mania rating scale (YMRS) and hamilton depression scale (HDRS-21) scores to determine clinical outcome of the patients
Corelating the MRI findings with the clinical outcomes of the study group.

Estimated Enrollment:	53
Study Start Date:	December 2004

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

diagnosis of type I or II bipolar disorder according to DSM-IV after stratified SCID I interview,
being currently euthimic (for at least one month), manic-hypomanic and having YMRS points of 15 or more, or being in depressive episode and having HAM-D21 points of 15 or more
being not taking drugs for at least two weeks before participating in the study (except benzodiazepins)

Exclusion Criteria:

female who are pregnant or planning to be pregnant, nursing
having known hypersensitivity to study drug
being given any psychotropic agent other than benzodiazepine within the last two weeks
active sustance or alcohol usage within the last two weeks, or substance addiction other than cafein or nicotine (within the last month)
having another axis I disorder such as comorbid dementia, delirium, obsessive compulsive disorder, eating disorder
having unstabilised hepatic or renal disorder, thyroid or blood disease
having history of cerebral surgery
existence of a degenerative neurologic disease or epilepsy
having pacemaker
having a prosthesis able to magnetic effect in eye, brain or sites near to these regions
homicide thougths or severe catatonia required to be hospitalized
having mixed episode

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431522

Locations

Turkey
Sanofi-Aventis
Istanbul, Turkey

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Edibe Taylan

Sanofi-aventis Turkey

More Information

Study ID Numbers:	L_9387
Study First Received:	February 2, 2007
Last Updated:	September 11, 2007
ClinicalTrials.gov Identifier:	NCT00431522
Health Authority:	Turkey: Ministry of Health

Study placed in the following topic categories:

Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder

Mood Disorders
Psychotic Disorders
Valproic Acid

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Enzyme Inhibitors

Antimanic Agents
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
GABA Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 14, 2009