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Valproic Acid Sodium Salt in Bipolar Disorder

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00431522
First received: February 2, 2007
Last updated: May 28, 2009
Last verified: May 2009
History of Changes
  Purpose
  • 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 Intervention Phase
Bipolar Disorder
 Drug: Valproic acid, sodium salt
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

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 [ Time Frame: for 6 weeks ] [ Designated as safety issue: No ]
  • To investigate valporate's effect on total and regional gray matter volume and NAA levels; [ Time Frame: for 6 weeks ] [ Designated as safety issue: No ]

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 [ Time Frame: for 6 weeks ] [ Designated as safety issue: No ]
  • To determine the relationship between clinical improvement and image data changes in depressed or manic/hypomanic patients, [ Time Frame: for 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: December 2004
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00431522

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

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00431522     History of Changes
Other Study ID Numbers: L_9387
Study First Received: February 2, 2007
Last Updated: May 28, 2009
Health Authority: Turkey: Ministry of Health

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
 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

ClinicalTrials.gov processed this record on May 23, 2013