Efficacy of Omega-3 Fatty Acids on Borderline Personality Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT00437099
First received: February 16, 2007
Last updated: May 26, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Borderline Personality Disorder.
Drug: Omacor®
Drug: Placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • Affective 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 ] [ Designated as safety issue: No ]
  • Impulsivity and aggressivity measured with the Time Paradigsm and the the Point Subtraction Aggression Paradigm. [ Time Frame: 0, 6, 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Impulsivity assessed by means of Barratt Impulsivity Scale-11 (BIS-11) [ Time Frame: Weeks 0, 2, 4, 6, 8, 10, 12 ] [ Designated as safety issue: No ]
  • Anger assessed by means of the State-Trait Anger Expression Inventory 2 (STAXI-2) [ Time Frame: Weeks 0, 2, 4, 6, 8, 10, 12 ] [ Designated as safety issue: No ]
  • anxiety assessed by means of the State-Trait Anxiety Inventory (STAI-E) [ Time Frame: weeks: 0, 6, 12 ] [ Designated as safety issue: No ]
  • Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Weeks: 0, 6, 12 ] [ Designated as safety issue: No ]
  • Global Activity Scale (EEAG) [ Time Frame: Weeks: 0, 6, 12 ] [ Designated as safety issue: No ]
  • Consumption of addictive substances with urine and breath drug testings and self-reports. [ Time Frame: Every week throghout the study ] [ Designated as safety issue: No ]
  • Social Adaptation Self-evaluation Scale (SASS) [ Time Frame: Weeks: 0, 6, 12 ] [ Designated as safety issue: No ]
  • Number of suicidal and parasuicidal episodes. [ Time Frame: Every week throughout the study ] [ Designated as safety issue: No ]
  • Number of visits to a psychiatric emergency service. [ Time Frame: Every week throughout the study ] [ Designated as safety issue: No ]
  • Plasmatic BDNF. [ Time Frame: Weeks 0, 12 ] [ Designated as safety issue: No ]
  • Adverse events. [ Time Frame: Every week throughout the study ] [ Designated as safety issue: Yes ]
  • Clinical impression assessed by means ICG [ Time Frame: weeks: 0, 2, 4, 6, 8, 10, 12 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: at each study visit ] [ Designated as safety issue: Yes ]
  • immediate memory assessed by means of the Immediate Memory Task [ Time Frame: Weeks 0, 6, 12 ] [ Designated as safety issue: No ]
  • Impulsivity assessed by means the two choice delayed reward test [ Time Frame: weeks: 0, 6, 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 102
Study Start Date: February 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
subjects with BPD receiving Omacor 1.680 mg/d
Drug: Omacor®
arm 1: Omacor 1680 Arm 2: Omacor 3360
Experimental: 2
BPD patients randomized to Omacor 3.360 mg/d
Drug: Omacor®
arm 1: Omacor 1680 Arm 2: Omacor 3360
Placebo Comparator: 3
patients with BPD randomized to Placebo
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00437099

Contacts
Contact: Miquel Casas, Prof 0034 93 489 42 94 mcasas@vhebron.net
Contact: Xavier Castells, MD 0034 93 489 42 94 xcc@icf.uab.cat

Locations
Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Miquel Casas, MD., Prof.    0034 93 489 42 94    mcasas@vhebron.net   
Sub-Investigator: Marc Ferrer, MD         
Sub-Investigator: Laura Alvarez         
Sub-Investigator: Oscar Andion         
Sub-Investigator: Jose L Matali         
Sub-Investigator: Sergi Valero         
Sub-Investigator: Xavier Castells, MD         
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
Principal Investigator: Miquel Casas, MD., Prof. Hospital Universitari Vall d'Hebron Barcelona, Catalonia, Spain
  More Information

No publications provided

Responsible Party: Miguel Casas Brugué, s
ClinicalTrials.gov Identifier: NCT00437099     History of Changes
Other Study ID Numbers: TLP-OMEGA 3
Study First Received: February 16, 2007
Last Updated: May 26, 2010
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014