Status:
UNKNOWN
Efficacy of Omega-3 Fatty Acids on Borderline Personality Disorder
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Conditions:
Borderline Personality Disorder.
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 rat...
Eligibility Criteria
Inclusion
- Meet DSM-IV criteria for BPD assessed by the Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II).
- Clinical Global Impression of Severity for BDP \> 3.
- Age between 18 and 65 years.
- Be able to give informed consent for participation.
- Place of residency compatible with the assistance to the center.
- If woman, use of effective contraception.
Exclusion
- Have a serious medical illness.
- History of omacor® allergy.
- Current diagnostic unipolar depression, bipolar disorder type I, Obsessive-Compulsive Disorder, schizophrenia and other psychotic disorders.
- DIB-R \> 8.
- Suicidal thinking that requires hospital admission.
- Meet DSM-IV criteria for alcohol, benzodiazepine, opioid or psychostimulant dependence in the six months prior to trial entry.
- Transaminase elevation within three times the upper limits of normality.
- Treatment with stable doses of antidepressants or mood stabilizers for less than six weeks.
- Treatment with stable doses of antipsychotics for more than 1 week in the last three months.
- Have received electroconvulsive therapy for the six months prior to trial entry.
- Have received DBT in the last 12 months prior to trial entry.
- Are pregnant or nursing.
- Have participated in any other investigational study in the last 6 months prior to trial entry.
- Current treatment or expectation to start any treatment with drugs that may interact with the study.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00437099
Start Date
February 1 2009
End Date
September 1 2011
Last Update
May 27 2010
Active Locations (1)
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1
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain, 08035