None listed
Conditions
Brief summary
On the basis of research background, we will perform a RCT in order to assess efficacy and tolerability of omega-3 fatty acids in combination with valproic acid in a group of BPD patients. We will recruit consecutive outpatients with a DSM-IV-TR diagnosis of borderline personality disorder (BPD), who will be randomly assigned to two treatment arms for twelve weeks: (1) valproic acid (800-1300 mg/day) (plasma range: 50-100 microg/ml), (2) EPA (1.2 g/day) and DHA (0.8 g/day) in combination with the same dose of valproic acid. Patients will be assessed with the Clinical Global Impression Scale, item Severity (CGI-S), the Hamilton Rating Scales For Depression and Anxiety (HAM-D, HAM-A), the Social Occupational Functioning Assessment Scale (SOFAS), the BPD Severity Index (BPDSI), the Barratt Impulsiveness Scale, version 11 (BIS-11), the Modified Overt Aggression Scale (MOAS), and the Self Harm Inventory (SHI). Adverse effects will be evaluated with the Dosage Record and Treatment Emergent Symptom Scale (DOTES).
Interventions
Eicosapentaenoic acid (EPA; 1.2 g/day) and docosahexaenoic acid (DHA; 0.8 g/day) in combination with valproic acid (800-1300 mg/day) (plasma range: 50-100 microg/ml). All drugs are administered daily for 12 weeks as oral tablets. The dose of valproic acid will be determined by treating clinician on the basis of plasma range.
Sponsors
Centre for Personality Disorders, Psychiatric Clinic 1, Department of Neuroscience, University of Turin, Italy
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Patients with a diagnosis of borderline personality disorder
Exclusion criteria
Dementia, delirium and other cognitive disorders; schizophrenia and other psychotic disorders. Lifetime bipolar disorders. Concurrent major depressive episode. Substance abuse in the last two months.
Outcome results
None listed