Efficacy of Omega-3 Fatty Acids on Borderline Personality Disorder

NCT00437099 | Unknown Phase 4

• 1 other identifier: TLP-OMEGA 3
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Borderline Personality Disorder.

Outcome Measures

Primary Outcomes (2)

• 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

• Impulsivity and aggressivity measured with the Time Paradigsm and the the Point Subtraction Aggression Paradigm.

  0, 6, 12

Secondary Outcomes (15)

• Impulsivity assessed by means of Barratt Impulsivity Scale-11 (BIS-11)

  Weeks 0, 2, 4, 6, 8, 10, 12

• Anger assessed by means of the State-Trait Anger Expression Inventory 2 (STAXI-2)

  Weeks 0, 2, 4, 6, 8, 10, 12

• anxiety assessed by means of the State-Trait Anxiety Inventory (STAI-E)

  weeks: 0, 6, 12

• Brief Psychiatric Rating Scale (BPRS)

  Weeks: 0, 6, 12

• Global Activity Scale (EEAG)

  Weeks: 0, 6, 12

Study Arms (3)

1

EXPERIMENTAL

subjects with BPD receiving Omacor 1.680 mg/d

Drug: Omacor®

2

EXPERIMENTAL

BPD patients randomized to Omacor 3.360 mg/d

Drug: Omacor®

3

PLACEBO COMPARATOR

patients with BPD randomized to Placebo

Drug: Placebo

Interventions

Omacor® DRUG

arm 1: Omacor 1680 Arm 2: Omacor 3360

1; 2

Placebo DRUG

Placebo

3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

RECRUITING

Related Publications (1)

• Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.

  PMID: 36375174 DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Omacor

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Officials

• Miquel Casas, MD., Prof.

  Hospital Universitari Vall d'Hebron Barcelona, Catalonia, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miquel Casas, Prof

CONTACT

0034 93 489 42 94; mcasas@vhebron.net

Xavier Castells, MD

CONTACT

0034 93 489 42 94; xcc@icf.uab.cat

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 16, 2007
• First Posted: February 19, 2007
• Study Start: February 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 27, 2010

Record last verified: 2010-05

Locations

ES (1)