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Valproic Acid Sodium Salt in Bipolar Disorder

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Sanofi

Status and phase

Completed
Phase 4

Conditions

Bipolar Disorder

Treatments

Drug: Valproic acid, sodium salt

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

  • 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

Enrollment

58 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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