Valproic Acid Sodium Salt in Bipolar Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2006-10-31

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

Detailed Description

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Conditions

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Bipolar Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Valproic acid, sodium salt

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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sanofi-aventis

Principal Investigators

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Edibe Taylan

Role: STUDY_DIRECTOR

Sanofi-aventis Turkey

Locations

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Sanofi-Aventis Administrative Office

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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L_9387

Identifier Type: -

Identifier Source: org_study_id