NCT00437099

Efficacy of Omega-3 Fatty Acids on Borderline Personality Disorder

Efficacy of Omega-3 Fatty Acids on Borderline Personality Disorder: a Randomized, Double Blind Clinical Trial.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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- CBT+placebo, 2- CBT+Omacor 1680 mg/d, 3- CBT+Omacor 3360 mg/d. 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.

Conditions

• Borderline Personality Disorder.

Interventions

Type	Name	Description
DRUG	Omacor®	arm 1: Omacor 1680 Arm 2: Omacor 3360
DRUG	Placebo	Placebo

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-02-01
• Completion: 2011-09-01
• First posted: 2007-02-19
• Last updated: 2010-05-27

Locations

1 site across 1 country: Spain