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Efficacy of Omega-3 Fatty Acids on Borderline Personality Disorder

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ClinicalTrials.gov Identifier: NCT00437099
Recruitment Status : Unknown
Verified May 2010 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was:  Recruiting
First Posted : February 19, 2007
Last Update Posted : May 27, 2010
Sponsor:
Information provided by:
Hospital Universitari Vall d'Hebron Research Institute

Tracking Information
First Submitted Date  ICMJE February 16, 2007
First Posted Date  ICMJE February 19, 2007
Last Update Posted Date May 27, 2010
Study Start Date  ICMJE February 2009
Estimated Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2009)
  • 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 ]
  • Impulsivity and aggressivity measured with the Time Paradigsm and the the Point Subtraction Aggression Paradigm. [ Time Frame: 0, 6, 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 16, 2007)
  • Affective symptoms measured with the Hamilton Depression Scale (Ham-D) and the Young Mania Rating Scale (YMRS).
  • Impulsivity and aggressivity measured with a self-control task of impulsivity (Chereck y cols., 1997) and the the Point Subtraction Aggression Paradigm (PTSP; Dougherty y cols., 1999).
Change History Complete list of historical versions of study NCT00437099 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2007)
  • Barratt Impulsivity Scale-11 (BIS-11)
  • State-Trait Anger Expression Inventory 2 (STAXI-2)
  • State-Trait Anxiety Inventory (STAI-E)
  • Brief Psychiatric Rating Scale (BPRS)
  • Global Activity Scale (EEAG)
  • Consumption of addictive substances with urine and breath drug testings.
  • Social Adaptation Self-evaluation Scale (SASS)
  • Number of suicidal and parasuicidal episodes.
  • Number of visits to a psychiatric emergency service.
  • Plasmatic BDNF.
  • Adverse events.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Omega-3 Fatty Acids on Borderline Personality Disorder
Official Title  ICMJE Efficacy of Omega-3 Fatty Acids on Borderline Personality Disorder: a Randomized, Double Blind Clinical Trial.
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 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Borderline Personality Disorder.
Intervention  ICMJE
  • Drug: Omacor®
    arm 1: Omacor 1680 Arm 2: Omacor 3360
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: 1
    subjects with BPD receiving Omacor 1.680 mg/d
    Intervention: Drug: Omacor®
  • Experimental: 2
    BPD patients randomized to Omacor 3.360 mg/d
    Intervention: Drug: Omacor®
  • Placebo Comparator: 3
    patients with BPD randomized to Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 16, 2007)
102
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2011
Estimated Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00437099
Other Study ID Numbers  ICMJE TLP-OMEGA 3
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Miguel Casas Brugué, s
Study Sponsor  ICMJE Hospital Universitari Vall d'Hebron Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Miquel Casas, MD., Prof. Hospital Universitari Vall d'Hebron Barcelona, Catalonia, Spain
PRS Account Hospital Universitari Vall d'Hebron Research Institute
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP