Valproic Acid Sodium Salt in Bipolar Disorder

NCT00431522 | Completed Phase 4

• 1 other identifier: L_9387
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (2)

• 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

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

  for 6 weeks

Secondary Outcomes (2)

• 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

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

  for 6 weeks

Interventions

Valproic acid, sodium salt DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Edibe Taylan

  Sanofi-aventis Turkey

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 2, 2007
• First Posted: February 5, 2007
• Study Start: December 1, 2004
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: May 29, 2009

Record last verified: 2009-05

Locations

TU (1)