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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
102
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain
RECRUITINGAffective symptoms measured with the Hamilton Depression Scale (Ham-D) and the Young Mania Rating Scale (YMRS).
Time frame: weeks: 0, 2, 4, 6, 8, 10, 12
Impulsivity and aggressivity measured with the Time Paradigsm and the the Point Subtraction Aggression Paradigm.
Time frame: 0, 6, 12
Impulsivity assessed by means of Barratt Impulsivity Scale-11 (BIS-11)
Time frame: Weeks 0, 2, 4, 6, 8, 10, 12
Anger assessed by means of the State-Trait Anger Expression Inventory 2 (STAXI-2)
Time frame: Weeks 0, 2, 4, 6, 8, 10, 12
anxiety assessed by means of the State-Trait Anxiety Inventory (STAI-E)
Time frame: weeks: 0, 6, 12
Brief Psychiatric Rating Scale (BPRS)
Time frame: Weeks: 0, 6, 12
Global Activity Scale (EEAG)
Time frame: Weeks: 0, 6, 12
Consumption of addictive substances with urine and breath drug testings and self-reports.
Time frame: Every week throghout the study
Social Adaptation Self-evaluation Scale (SASS)
Time frame: Weeks: 0, 6, 12
Number of suicidal and parasuicidal episodes.
Time frame: Every week throughout the study
Number of visits to a psychiatric emergency service.
Time frame: Every week throughout the study
Plasmatic BDNF.
Time frame: Weeks 0, 12
Adverse events.
Time frame: Every week throughout the study
Clinical impression assessed by means ICG
Time frame: weeks: 0, 2, 4, 6, 8, 10, 12
Adverse events
Time frame: at each study visit
immediate memory assessed by means of the Immediate Memory Task
Time frame: Weeks 0, 6, 12
Impulsivity assessed by means the two choice delayed reward test
Time frame: weeks: 0, 6, 12
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