Valproic Acid Sodium Salt in Bipolar Disorder

May 28, 2009 updated by: Sanofi

Protective Effect of Valproate on Brain Cells:A Magnetic Resonance Imaging and Spectroscopy Study in Patients With Bipolar Disorder Diagnosis

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

Study Overview

Status

Completed

Conditions

Bipolar Disorder

Intervention / Treatment

Drug: Valproic acid, sodium salt

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Turkey
- - Istanbul, Turkey
    - Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Factorial Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess regional N-acetyl aspartate (NAA) levels in drug free bipolar patients either in manic/hypomanic, or depressive or euthymic state Time Frame: for 6 weeks	for 6 weeks
To investigate valporate's effect on total and regional gray matter volume and NAA levels; Time Frame: for 6 weeks	for 6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess evoked and event related potentials to visual and auditory stimuli in patients before and after valproate monotherapy in comparison to healthy controls Time Frame: for 6 weeks	for 6 weeks
To determine the relationship between clinical improvement and image data changes in depressed or manic/hypomanic patients, Time Frame: for 6 weeks	for 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

Study Director: Edibe Taylan, Sanofi-aventis Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)