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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | subjects with BPD receiving Omacor 1.680 mg/d |
|
| 2 | Experimental | BPD patients randomized to Omacor 3.360 mg/d |
|
| 3 | Placebo Comparator | patients with BPD randomized to Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omacor® | Drug | arm 1: Omacor 1680 Arm 2: Omacor 3360 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Miquel Casas, MD., Prof. | Hospital Universitari Vall d'Hebron Barcelona, Catalonia, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | Barcelona | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36375174 | Derived | 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. |
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| ID | Term |
|---|---|
| D001883 | Borderline Personality Disorder |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C405603 | Omacor |
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| Placebo |
| Drug |
Placebo |
|
| 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 |
| Consumption of addictive substances with urine and breath drug testings and self-reports. | Every week throghout the study |
| Social Adaptation Self-evaluation Scale (SASS) | Weeks: 0, 6, 12 |
| Number of suicidal and parasuicidal episodes. | Every week throughout the study |
| Number of visits to a psychiatric emergency service. | Every week throughout the study |
| Plasmatic BDNF. | Weeks 0, 12 |
| Adverse events. | Every week throughout the study |
| Clinical impression assessed by means ICG | weeks: 0, 2, 4, 6, 8, 10, 12 |
| Adverse events | at each study visit |
| immediate memory assessed by means of the Immediate Memory Task | Weeks 0, 6, 12 |
| Impulsivity assessed by means the two choice delayed reward test | weeks: 0, 6, 12 |