Efficacy of Omega-3 Fatty Acids on Borderline Personality Disorder: a Randomized, Double Blind Clinical Trial.
试验速览
- 阶段
- 4 期
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Affective symptoms measured with the Hamilton Depression Scale (Ham-D) and the Young Mania Rating Scale (YMRS).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 >
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
1
subjects with BPD receiving Omacor 1.680 mg/d
干预措施: Omacor® (Drug)
2
BPD patients randomized to Omacor 3.360 mg/d
干预措施: Omacor® (Drug)
3
patients with BPD randomized to Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Affective symptoms measured with the Hamilton Depression Scale (Ham-D) and the Young Mania Rating Scale (YMRS).
时间窗: weeks: 0, 2, 4, 6, 8, 10, 12
Impulsivity and aggressivity measured with the Time Paradigsm and the the Point Subtraction Aggression Paradigm.
时间窗: 0, 6, 12
次要结局
- Number of visits to a psychiatric emergency service.(Every week throughout the study)
- Clinical impression assessed by means ICG(weeks: 0, 2, 4, 6, 8, 10, 12)
- Impulsivity assessed by means of Barratt Impulsivity Scale-11 (BIS-11)(Weeks 0, 2, 4, 6, 8, 10, 12)
- Social Adaptation Self-evaluation Scale (SASS)(Weeks: 0, 6, 12)
- Brief Psychiatric Rating Scale (BPRS)(Weeks: 0, 6, 12)
- Anger assessed by means of the State-Trait Anger Expression Inventory 2 (STAXI-2)(Weeks 0, 2, 4, 6, 8, 10, 12)
- Global Activity Scale (EEAG)(Weeks: 0, 6, 12)
- Number of suicidal and parasuicidal episodes.(Every week throughout the study)
- Consumption of addictive substances with urine and breath drug testings and self-reports.(Every week throghout the study)
- anxiety assessed by means of the State-Trait Anxiety Inventory (STAI-E)(weeks: 0, 6, 12)
- Adverse events(at each study visit)
- immediate memory assessed by means of the Immediate Memory Task(Weeks 0, 6, 12)
- Plasmatic BDNF.(Weeks 0, 12)
- Adverse events.(Every week throughout the study)
- Impulsivity assessed by means the two choice delayed reward test(weeks: 0, 6, 12)