Valproic Acid Sodium Salt in Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00431522
• Other study ID #: L_9387
• Status: Completed
• Phase: Phase 4
• First received: February 2, 2007
• Last updated: May 28, 2009
• Start date: December 2004
• Est. completion date: October 2006

Study information

• Verified date: May 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Valproic acid, sodium salt

Locations

Country	Name	City	State
Turkey	Sanofi-Aventis Administrative Office	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess regional N-acetyl aspartate (NAA) levels in drug free bipolar patients either in manic/hypomanic, or depressive or euthymic state		for 6 weeks	No
Primary	To investigate valporate's effect on total and regional gray matter volume and NAA levels;		for 6 weeks	No
Secondary	To assess evoked and event related potentials to visual and auditory stimuli in patients before and after valproate monotherapy in comparison to healthy controls		for 6 weeks	No
Secondary	To determine the relationship between clinical improvement and image data changes in depressed or manic/hypomanic patients,		for 6 weeks	No