Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00437099
Status:
UNKNOWN
Last Update Posted:
2010-05-27
First Post:
2007-02-16
Brief Title:
Efficacy of Omega-3 Fatty Acids on Borderline Personality Disorder
Sponsor:
Hospital Universitari Vall dHebron Research Institute
Organization:
Hospital Universitari Vall dHebron Research Institute
Study Overview
Official Title:
Efficacy of Omega-3 Fatty Acids on Borderline Personality Disorder a Randomized Double Blind Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2010-05
Last Known Status:
RECRUITING
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:
Borderline Personality Disorder BDP is a serious mental disorder that affects about 1-2 of the general population and it is characterized by severe psychosocial impairment and a high mortality rate due to suicide Currently the most effective treatments for BPD are psychotherapy cognitive behavior therapy - CBT - and pharmacotherapy often as an important adjunctive role especially for diminution of symptoms such as affective instability impulsivity psychotic-like symptoms and self-destructive behavior Nevertheless although several drugs are used in these patients these drugs induce an improvement of some symptoms but do not cause the remission of BPD Thus identification of novel treatments is needed
The objective of this study is to examine the efficacy of Omacor a mixture of omega-3-acid ethyl esters eicosapentaenoic acid EPA and docosahexaenoic acid DHA for BDP patients receiving CBT Patients with BDP will be randomly allocated to the three arms of the study 1- CBTplacebo 2- CBTOmacor 1680 mgd 3- CBTOmacor 3360 mgd Follow up will last for 12 weeks Assessment of affective symptoms impulsivity and aggressivity will be carried out at baseline and at 2 4 6 8 10 and 12 weeks
The objective of this study is to examine the efficacy of Omacor a mixture of omega-3-acid ethyl esters eicosapentaenoic acid EPA and docosahexaenoic acid DHA for BDP patients receiving CBT Patients with BDP will be randomly allocated to the three arms of the study 1- CBTplacebo 2- CBTOmacor 1680 mgd 3- CBTOmacor 3360 mgd Follow up will last for 12 weeks Assessment of affective symptoms impulsivity and aggressivity will be carried out at baseline and at 2 4 6 8 10 and 12 weeks
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