Valproic Acid Sodium Salt in Bipolar Disorder

Study Overview
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Brief Summary
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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

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

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Drug: Valproic acid, sodium salt


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Valproic acid, sodium salt|nan|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | for 6 weeks | 
| To determine the relationship between clinical improvement and image data changes in depressed or manic/hypomanic patients, |  | for 6 weeks |