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Efficacy of Omega-3 Fatty Acids on Borderline Personality Disorder

Primary Purpose

Borderline Personality Disorder.

Status

Unknown status

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Omacor®

Placebo

About this trial

This is an interventional treatment trial for Borderline Personality Disorder.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Hospital Universitari Vall d'HebronRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

subjects with BPD receiving Omacor 1.680 mg/d

BPD patients randomized to Omacor 3.360 mg/d

patients with BPD randomized to Placebo

Outcomes

Primary Outcome Measures

Affective symptoms measured with the Hamilton Depression Scale (Ham-D) and the Young Mania Rating Scale (YMRS).

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

Secondary Outcome Measures

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

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

anxiety assessed by means of the 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 and self-reports.

Social Adaptation Self-evaluation Scale (SASS)

Number of suicidal and parasuicidal episodes.

Number of visits to a psychiatric emergency service.

Plasmatic BDNF.

Adverse events.

Clinical impression assessed by means ICG

Adverse events

immediate memory assessed by means of the Immediate Memory Task

Impulsivity assessed by means the two choice delayed reward test

Full Information

NCT ID

NCT00437099

First Posted

February 16, 2007

Last Updated

May 26, 2010

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT00437099

Brief Title

Efficacy of Omega-3 Fatty Acids on Borderline Personality Disorder

Official Title

Efficacy of Omega-3 Fatty Acids on Borderline Personality Disorder: a Randomized, Double Blind Clinical Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Unknown status

Study Start Date

February 2009 (undefined)

Primary Completion Date

February 2011 (Anticipated)

Study Completion Date

September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Borderline Personality Disorder.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

subjects with BPD receiving Omacor 1.680 mg/d

Arm Title

Arm Type

Experimental

Arm Description

BPD patients randomized to Omacor 3.360 mg/d

Arm Title

Arm Type

Placebo Comparator

Arm Description

patients with BPD randomized to Placebo

Intervention Type

Drug

Intervention Name(s)

Omacor®

Intervention Description

arm 1: Omacor 1680 Arm 2: Omacor 3360

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

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

Title

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

Time Frame

0, 6, 12

Secondary Outcome Measure Information:

Title

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

Time Frame

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

Title

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

Time Frame

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

Title

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

Time Frame

weeks: 0, 6, 12

Title

Brief Psychiatric Rating Scale (BPRS)

Time Frame

Weeks: 0, 6, 12

Title

Global Activity Scale (EEAG)

Time Frame

Weeks: 0, 6, 12

Title

Consumption of addictive substances with urine and breath drug testings and self-reports.

Time Frame

Every week throghout the study

Title

Social Adaptation Self-evaluation Scale (SASS)

Time Frame

Weeks: 0, 6, 12

Title

Number of suicidal and parasuicidal episodes.

Time Frame

Every week throughout the study

Title

Number of visits to a psychiatric emergency service.

Time Frame

Every week throughout the study

Title

Plasmatic BDNF.

Time Frame

Weeks 0, 12

Title

Adverse events.

Time Frame

Every week throughout the study

Title

Clinical impression assessed by means ICG

Time Frame

weeks: 0, 2, 4, 6, 8, 10, 12

Title

Adverse events

Time Frame

at each study visit

Title

immediate memory assessed by means of the Immediate Memory Task

Time Frame

Weeks 0, 6, 12

Title

Impulsivity assessed by means the two choice delayed reward test

Time Frame

weeks: 0, 6, 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Miquel Casas, Prof

Phone

0034 93 489 42 94

mcasas@vhebron.net

First Name & Middle Initial & Last Name or Official Title & Degree

Xavier Castells, MD

Phone

0034 93 489 42 94

xcc@icf.uab.cat

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Miquel Casas, MD., Prof.

Organizational Affiliation

Hospital Universitari Vall d'Hebron Barcelona, Catalonia, Spain

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitari Vall d'Hebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Miquel Casas, MD., Prof.

Phone

0034 93 489 42 94

mcasas@vhebron.net

First Name & Middle Initial & Last Name & Degree

Marc Ferrer, MD

First Name & Middle Initial & Last Name & Degree

Laura Alvarez

First Name & Middle Initial & Last Name & Degree

Oscar Andion

First Name & Middle Initial & Last Name & Degree

Jose L Matali

First Name & Middle Initial & Last Name & Degree

Sergi Valero

First Name & Middle Initial & Last Name & Degree

Xavier Castells, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

36375174

Citation

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.

Results Reference

derived

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Efficacy of Omega-3 Fatty Acids on Borderline Personality Disorder

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