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Valproic Acid Sodium Salt in Bipolar Disorder

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Valproic acid, sodium salt
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office

Outcomes

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

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

Full Information

First Posted
February 2, 2007
Last Updated
May 28, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00431522
Brief Title
Valproic Acid Sodium Salt in Bipolar Disorder
Official Title
Protective Effect of Valproate on Brain Cells:A Magnetic Resonance Imaging and Spectroscopy Study in Patients With Bipolar Disorder Diagnosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Valproic acid, sodium salt
Primary Outcome Measure Information:
Title
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
Title
To investigate valporate's effect on total and regional gray matter volume and NAA levels;
Time Frame
for 6 weeks
Secondary Outcome Measure Information:
Title
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
Title
To determine the relationship between clinical improvement and image data changes in depressed or manic/hypomanic patients,
Time Frame
for 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edibe Taylan
Organizational Affiliation
Sanofi-aventis Turkey
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

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Valproic Acid Sodium Salt in Bipolar Disorder

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