Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00186186
Status:
COMPLETED
Last Update Posted:
2017-04-12
First Post:
2005-09-13
Brief Title:
Depakote ER in Bipolar Depression
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Depakote ER in Bipolar Depression
Status:
COMPLETED
Status Verified Date:
2017-03
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:
The purpose of this study is to examine the safety and efficacy of Depakote ER in bipolar depression and to evaluate metabolic and GABA changes with Depakote ER administration using PET and MRIMRS brain imaging techniques
Detailed Description:
Mood disorders are important public health problems Bipolar disorder is a major psychiatric disorder characterized by mood cycles alternating between mania and depression and affects approximately 1 of the population Most patients are treated beginning in the early twenties and then embark on a course marked by multiple recurrences hospitalizations and encounters with legal authorities These disorders inflict substantial morbidity which yields important deficits in occupational and interpersonal function The risk of suicide in mood disorders may be as high as 10
Although the outlook for recovery from acute manic or depressive episodes is generally excellent the long-term prognosis of the disorder varies tremendously across the patient population The introduction of lithium anticonvulsants and atypical antipsychotics significantly changes the outlook for bipolar disorder with some individuals on chronic treatment attaining complete remission and indefinite prophylaxis against mood episodes However such optimum outcomes may be limited to as few as one-third to one-half of all treated patients The remaining experiences various combinations of breakthrough mood episodes including chronic mood instability persistent depression and rapid cycling
Very little research has been conducted with bipolar disorder and no medications have an FDA indication to treat bipolar depression Previous studies suggest that Depakote is promising in the treatment of mixed and depressed episodes of bipolar disorder This study utilizes the extended release formulation of divalproex sodium with demonstrated increased tolerability
We propose investigating safety tolerability and efficacy of Depakote ER monotherapy in Bipolar I II or NOS depression and monitoring associated changes in brain GABA levels In addition we intend to evaluate and assess the differences between brain metabolic rate and GABA levels in bipolar disorder patients and healthy volunteers
Although the outlook for recovery from acute manic or depressive episodes is generally excellent the long-term prognosis of the disorder varies tremendously across the patient population The introduction of lithium anticonvulsants and atypical antipsychotics significantly changes the outlook for bipolar disorder with some individuals on chronic treatment attaining complete remission and indefinite prophylaxis against mood episodes However such optimum outcomes may be limited to as few as one-third to one-half of all treated patients The remaining experiences various combinations of breakthrough mood episodes including chronic mood instability persistent depression and rapid cycling
Very little research has been conducted with bipolar disorder and no medications have an FDA indication to treat bipolar depression Previous studies suggest that Depakote is promising in the treatment of mixed and depressed episodes of bipolar disorder This study utilizes the extended release formulation of divalproex sodium with demonstrated increased tolerability
We propose investigating safety tolerability and efficacy of Depakote ER monotherapy in Bipolar I II or NOS depression and monitoring associated changes in brain GABA levels In addition we intend to evaluate and assess the differences between brain metabolic rate and GABA levels in bipolar disorder patients and healthy volunteers
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