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Valproic Acid Sodium Salt in Bipolar Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00431522
Recruitment Status : Completed
First Posted : February 5, 2007
Last Update Posted : May 29, 2009
Information provided by:

Study Description
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

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Valproic acid, sodium salt Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Protective Effect of Valproate on Brain Cells:A Magnetic Resonance Imaging and Spectroscopy Study in Patients With Bipolar Disorder Diagnosis
Study Start Date : December 2004
Primary Completion Date : October 2006
Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00431522

Sanofi-Aventis Administrative Office
Istanbul, Turkey
Sponsors and Collaborators
Study Director: Edibe Taylan Sanofi-aventis Turkey
More Information

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00431522     History of Changes
Other Study ID Numbers: L_9387
First Posted: February 5, 2007    Key Record Dates
Last Update Posted: May 29, 2009
Last Verified: May 2009

Additional relevant MeSH terms:
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Valproic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs