Efficacy of Omega-3 Fatty Acids on Borderline Personality Disorder
Status:
Unknown status
Trial end date:
2011-09-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute