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.
| Status | Recruiting |
| Enrollment | 102 |
| Est. completion date | September 2011 |
| Est. primary completion date | February 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: 1. Meet DSM-IV criteria for BPD assessed by the Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II). 2. Clinical Global Impression of Severity for BDP > 3. 3. Age between 18 and 65 years. 4. Be able to give informed consent for participation. 5. Place of residency compatible with the assistance to the center. 6. If woman, use of effective contraception. Exclusion Criteria: 1. Have a serious medical illness. 2. History of omacor® allergy. 3. Current diagnostic unipolar depression, bipolar disorder type I, Obsessive-Compulsive Disorder, schizophrenia and other psychotic disorders. 4. DIB-R > 8. 5. Suicidal thinking that requires hospital admission. 6. Meet DSM-IV criteria for alcohol, benzodiazepine, opioid or psychostimulant dependence in the six months prior to trial entry. 7. Transaminase elevation within three times the upper limits of normality. 8. Treatment with stable doses of antidepressants or mood stabilizers for less than six weeks. 9. Treatment with stable doses of antipsychotics for more than 1 week in the last three months. 10. Have received electroconvulsive therapy for the six months prior to trial entry. 11. Have received DBT in the last 12 months prior to trial entry. 12. Are pregnant or nursing. 13. Have participated in any other investigational study in the last 6 months prior to trial entry. 14. Current treatment or expectation to start any treatment with drugs that may interact with the study. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Universitari Vall d'Hebron | Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Universitari Vall d'Hebron Research Institute |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Affective symptoms measured with the Hamilton Depression Scale (Ham-D) and the Young Mania Rating Scale (YMRS). | weeks: 0, 2, 4, 6, 8, 10, 12 | No | |
| Primary | Impulsivity and aggressivity measured with the Time Paradigsm and the the Point Subtraction Aggression Paradigm. | 0, 6, 12 | No | |
| Secondary | Impulsivity assessed by means of Barratt Impulsivity Scale-11 (BIS-11) | Weeks 0, 2, 4, 6, 8, 10, 12 | No | |
| Secondary | Anger assessed by means of the State-Trait Anger Expression Inventory 2 (STAXI-2) | Weeks 0, 2, 4, 6, 8, 10, 12 | No | |
| Secondary | anxiety assessed by means of the State-Trait Anxiety Inventory (STAI-E) | weeks: 0, 6, 12 | No | |
| Secondary | Brief Psychiatric Rating Scale (BPRS) | Weeks: 0, 6, 12 | No | |
| Secondary | Global Activity Scale (EEAG) | Weeks: 0, 6, 12 | No | |
| Secondary | Consumption of addictive substances with urine and breath drug testings and self-reports. | Every week throghout the study | No | |
| Secondary | Social Adaptation Self-evaluation Scale (SASS) | Weeks: 0, 6, 12 | No | |
| Secondary | Number of suicidal and parasuicidal episodes. | Every week throughout the study | No | |
| Secondary | Number of visits to a psychiatric emergency service. | Every week throughout the study | No | |
| Secondary | Plasmatic BDNF. | Weeks 0, 12 | No | |
| Secondary | Adverse events. | Every week throughout the study | Yes | |
| Secondary | Clinical impression assessed by means ICG | weeks: 0, 2, 4, 6, 8, 10, 12 | No | |
| Secondary | Adverse events | at each study visit | Yes | |
| Secondary | immediate memory assessed by means of the Immediate Memory Task | Weeks 0, 6, 12 | No | |
| Secondary | Impulsivity assessed by means the two choice delayed reward test | weeks: 0, 6, 12 | No |