Valproic Acid Sodium Salt in Bipolar Disorder
Study Details
Study Description
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;
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To investigate the neuroprotective effects of long-term (6 weeks) use of valproate on total and local gray matter volumes and NAA levels.
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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.
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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;
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To determine the relationship between these effects of valproate and clinical improvement;
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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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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diagnosis of type I or II bipolar disorder according to DSM-IV after stratified SCID I interview,
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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
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being not taking drugs for at least two weeks before participating in the study (except benzodiazepins)
Exclusion Criteria:
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female who are pregnant or planning to be pregnant, nursing
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having known hypersensitivity to study drug
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being given any psychotropic agent other than benzodiazepine within the last two weeks
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active sustance or alcohol usage within the last two weeks, or substance addiction other than cafein or nicotine (within the last month)
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having another axis I disorder such as comorbid dementia, delirium, obsessive compulsive disorder, eating disorder
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having unstabilised hepatic or renal disorder, thyroid or blood disease
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having history of cerebral surgery
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existence of a degenerative neurologic disease or epilepsy
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having pacemaker
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having a prosthesis able to magnetic effect in eye, brain or sites near to these regions
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homicide thougths or severe catatonia required to be hospitalized
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-Aventis Administrative Office | Istanbul | Turkey |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Edibe Taylan, Sanofi-aventis Turkey
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- L_9387