Borderline Personality Disorder. Clinical Trial
Official title:
Efficacy of Omega-3 Fatty Acids on Borderline Personality Disorder: a Randomized, Double Blind Clinical Trial.
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment