Ziprasidone in the Treatment of Borderline Personality Disorder: A Double-Blind, Placebo-Controlled, Randomized Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- CGI scale for use in borderline personality disorder (CGI-BPD)
研究概览
简要总结
Objective: The aim of this double-blind, placebo-controlled study was to evaluate the efficacy and tolerability of ziprasidone in the treatment of adult patients with Borderline Personality Disorder (BPD).
Method: Sixty BPD patients were included in a 12-week, single-center, double-blind, placebo-controlled study. The subjects were randomly assigned to ziprasidone or placebo in a 1:1 ratio following a two-week baseline period. The Clinical Global Impression scale for use in BPD patients (CGI-BPD) was the primary outcome measure, and other scales and self-reports related to affect, behavior, psychosis, general psychopathology domains and clinical safety were included.
详细描述
The American Psychiatric Association (APA) Guidelines for the Treatment of Borderline personality disorder recommend that pharmacological treatment for BPD has an important adjunctive role, especially for diminution of symptoms such as affective instability, impulsivity, psychotic-like symptoms, and self-destructive behavior. Studies conducted with low doses of conventional antipsychotics have showed significant improvements in specific symptoms such as hostility, impulsiveness, mood, and psychotic symptoms.
The introduction of atypical antipsychotics, with a more favorable tolerance profile, increases clinicians' options for treating BPD. Olanzapine has proven its efficacy in four double-blind, placebo-controlled clinical trials in patients with BPD. Ziprasidone is an atypical antipsychotic with a pharmacological action on serotonergic, dopaminergic and adrenergic receptors. It has proven to be effective for schizophrenia, schizoaffective and acute mania disorders and the incidence of side effects is low.
Although clinical findings and the pharmacological activity of ziprasidone suggest the drug may have therapeutic benefits in BPD patients, no controlled studies have yet been conducted in these patients. We carried out a randomized, double-blind, placebo-controlled study to evaluate efficacy and tolerability of ziprasidone in the management of BPD patients with moderate-high clinical severity.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV diagnosis of Borderline Personality Disorder
- •Age between 18 and 45 years
- •Clinical Global Impression of Severity (CGI-S)scores >4
排除标准
- •No comorbidity with schizophrenia, drug-induced psychosis, organic brain syndrome, alcohol or other substance dependence, bipolar disorder, mental retardation, or major depressive episode in course
- •current use of medically accepted contraception in the case of female patients.
研究组 & 干预措施
I ziprasidone
干预措施: ziprasidone (Drug)
II placebo
干预措施: Placebo (Drug)
结局指标
主要结局
CGI scale for use in borderline personality disorder (CGI-BPD)
时间窗: 12 weeks
次要结局
- EKG and laboratory assessment(12 weeks)
- Buss-Durkee Inventory(12 weeks)
- UKU Side Effect Rating Scale(12 weeks)
- Hamilton Rating Scale Depression (HAM-D-17)(12 weeks)
- Hamilton Rating Scale for Anxiety (HAM-A)(12 weeks)
- Brief Psychiatric Rating Scale (BPRS)(12 weeks)
- SCL-90-R(12 weeks)
- Barratt Impulsiveness Scale(12 weeks)
- Treatment-emergent adverse events(12 weeks)