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Completed

NCT Number: NCT00431522

Valproic Acid Sodium Salt in Bipolar Disorder

* 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

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Valproic acid, sodium salt

Drug

Primary outcomes

  1. To assess regional N-acetyl aspartate (NAA) levels in drug free bipolar patients either in manic/hypomanic, or depressive or euthymic state

    Time frame: for 6 weeks

  2. To investigate valporate's effect on total and regional gray matter volume and NAA levels;

    Time frame: for 6 weeks

Secondary outcomes

  1. To assess evoked and event related potentials to visual and auditory stimuli in patients before and after valproate monotherapy in comparison to healthy controls

    Time frame: for 6 weeks

  2. To determine the relationship between clinical improvement and image data changes in depressed or manic/hypomanic patients,

    Time frame: for 6 weeks

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Feb 5, 2007
Registry last updated
May 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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