Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010868
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2001-02-02
Brief Title:
Omega-3 Fatty Acids in Bipolar Disorder
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Omega-3 Fatty Acids in Bipolar Disorder Prophylaxis
Status:
COMPLETED
Status Verified Date:
2006-07
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:
This is a 12 month study of omega-3 fatty acids in bipolar disorder This study will be a 12-month parallel group double-blind comparison of the prophylactic efficacy of omega-3 fatty acids vs placebo in 120 bipolar I patients All subjects entering the primary prophylactic study will be euthymic or have only subsyndromal mood symptoms for at least 4 weeks In addition their concomitant medication only lithium divalproex or no medication will be permitted will also be stable and at accepted therapeutic levels for at least 4 weeks An 8-week lead-in phase will be available to subjects who do not meet the current symptom and concomitant medication inclusion criteria however subjects must meet all of the other inclusionexclusion criteria 1 4 weeks of euthymic or subsyndromal mood 2 Subjects who are not already receiving lithium or divalproex 3 Subjects receiving other psychotropic medications
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