Efficacy of Omega-3 Fatty Acids on Borderline Personality Disorder - Full Text View

Sponsored by:	Hospital University Vall d'Hebron
Information provided by:	Hospital University Vall d'Hebron
ClinicalTrials.gov Identifier:	NCT00437099

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 behaviour therapy - CBT -) and pharmacotherapy (often as an important adjunctive role, especially for disminution of symptoms such as affective instability, impulsivity, psychotic-like symptoms and self-destructive behaviour). Nevertheless, although several drugs are used in these patients, these srugs 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. Assesment 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 IV

MedlinePlus related topics: Personality Disorders

Drug Information available for: Omacor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Eficacy of Omega-3 Fatty Acids on Borderline Personality Disorder: a Randomised, Double Blind Clinical Trial.

Further study details as provided by Hospital University Vall d'Hebron:

Primary Outcome Measures:

Affective symptoms measured with the Hamilton Depression Scale (Ham-D) and the Young Mania Rating Scale (YMRS). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Barratt Impulsivity Scale-11 (BIS-11) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
State-Trait Anger Expression Inventory 2 (STAXI-2) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
State-Trait Anxiety Inventory (STAI-E) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Global Activity Scale (EEAG) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Consumption of addictive substances with urine and breath drug testings. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Social Adaptation Self-evaluation Scale (SASS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Number of suicidal and parasuicidal episodes. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Number of visits to a psychiatric emergency service. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Plasmatic BDNF. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Adverse events. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	102
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental subjects with BPD receiving Omacor 1.680 mg/d	Drug: Omacor® arm 1: Omacor 1680 Arm 2: Omacor 3360
2: Experimental BPD patients randomized to Omacor 3.360 mg/d	Drug: Omacor® arm 1: Omacor 1680 Arm 2: Omacor 3360
3: Placebo Comparator 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:

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 of ADHD, 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.

Contacts and Locations

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
Barcelona, Spain, 08035

Sponsors and Collaborators

Hospital University Vall d'Hebron

Investigators

Principal Investigator:

Miquel Casas, MD., Prof.

Hospital Universitari Vall d'Hebron Barcelona, Catalonia, Spain

More Information

Responsible Party:	s ( Miguel Casas Brugué )
Study ID Numbers:	TLP-OMEGA 3
Study First Received:	February 16, 2007
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00437099
Health Authority:	Spain: Spanish Agency of Medicines

Study placed in the following topic categories:

Mental Disorders
Borderline Personality Disorder
Personality Disorders

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 15, 2009