Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00431522
Status:
COMPLETED
Last Update Posted:
2009-05-29
First Post:
2007-02-02
Brief Title:
Valproic Acid Sodium Salt in Bipolar Disorder
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Protective Effect of Valproate on Brain CellsA Magnetic Resonance Imaging and Spectroscopy Study in Patients With Bipolar Disorder Diagnosis
Status:
COMPLETED
Status Verified Date:
2009-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 manichypomanic 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 manichypomanic 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 MRIMRS findings in conjunction with localization
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 manichypomanic 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 MRIMRS findings in conjunction with localization
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None