The Effect of Quetiapine on Psychotic-Like Symptoms in Borderline Personality Disordered Patients: A Randomised Placebo-Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To explore in patients with BPD the effect of quetiapine on psychotic-like symptoms and severity of psychiatric symptoms
研究概览
简要总结
In patients with schizophrenia, 'atypical' antipsychotics such as clozapine may be effective in the treatment of psychosis. In patients with borderline personality disorder (BPD), as far as the investigators know, no well designed controlled studies have been performed on the effect of one of the newer atypical antipsychotics on psychotic symptoms.
It is of interest to investigate the benefit of quetiapine treatment in these types of patients. Quetiapine possibly gives less side-effects because of the expected lack of elevated prolactin levels, which is of importance in this patient group, overrepresented by young females. In this double blind, randomized, placebo controlled, 8 week, parallel group, multi-center study, quetiapine (in flexible doses between 200 mg/day and 600 mg/day) will be compared with the placebo.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with BPD according to Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV)/Structured Clinical Interview for DSM-IV Axis II Personality Disorders (SCID-II) including criterion 9: transient, stress related paranoid ideation or severe dissociative symptoms.
- •In- or outpatients
排除标准
- •Depressive disorder
- •Bipolar disorder
- •Schizoaffective disorder/schizophrenia/delusional disorder/schizotypal personality disorder
- •Alcohol- or substance dependence
- •Quetiapine doses >100mg od use in the past
- •History of trauma capitis
- •Visual and auditive disorders
- •Neurological disorders (epilepsy)
- •Pregnancy
- •No adequate contraception
- •History of cardial complaints/cardiological disorder
- •Known sensitivity for quetiapine
研究组 & 干预措施
1
Placebo
干预措施: Placebo (Drug)
2
Flexible doses of 200 mg/day to 600 mg/day quetiapine fumarate
干预措施: Quetiapine fumarate (Drug)
结局指标
主要结局
To explore in patients with BPD the effect of quetiapine on psychotic-like symptoms and severity of psychiatric symptoms
时间窗: assessed at each visit for 8 weeks
次要结局
- To explore the effect of quetiapine on mood, anger, impulsiveness, hostility and anxiety in patients with BPD(assessed at each visit for 8 weeks)