Clinical trial NCT00431522: Valproic Acid Sodium Salt in Bipolar Disorder
Official title: Protective Effect of Valproate on Brain Cells:A Magnetic Resonance Imaging and Spectroscopy Study in Patients With Bipolar Disorder Diagnosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-02-05
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: * 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


Eligibility 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.

Primary outcomes:
measure: To assess regional N-acetyl aspartate (NAA) levels in drug free bipolar patients either in manic/hypomanic, or depressive or euthymic state
timeFrame: for 6 weeks
measure: To investigate valporate's effect on total and regional gray matter volume and NAA levels;
timeFrame: for 6 weeks
Secondary outcomes:
measure: To assess evoked and event related potentials to visual and auditory stimuli in patients before and after valproate monotherapy in comparison to healthy controls
timeFrame: for 6 weeks
measure: To determine the relationship between clinical improvement and image data changes in depressed or manic/hypomanic patients,
timeFrame: for 6 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi-aventis Turkey
name: Edibe Taylan
role: STUDY_DIRECTOR
References: