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
Recruitment status was Recruiting
Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
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
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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:
- 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.
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 | 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 May 21, 2013