The Combination of Aripiprazole and Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants in the Acute Treatment of Psychotic Major Depression: Efficacy and Tolerability
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Depression and Psychosis Response Rate
研究概览
简要总结
The purpose of the study is to assess the safety and effectiveness of the combination of aripiprazole (Abilify) and selective serotonin reuptake inhibitors (SSRIs) in subjects with psychotic major depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18-80 years, inclusive.
- •Drug-free outpatients or inpatients meeting DSM-IV criteria for major depression with psychotic features.
- •Inpatients who undergo a 5-7 day washout period of their medication while concurrently beginning one of the approved SSRI's and abilify.
- •HAM-D-24 score > 16.
排除标准
- •Pregnant women and women of child bearing potential not using a medically accepted means of contraception (oral contraceptives are allowed).
- •Women who are breast-feeding.
- •Patients meeting DSM-IV criteria for major depression without psychotic features, or psychosis without major depression at the screen visit.
- •Patients with serious suicidal risk.
- •Patients with a history of seizure disorder; unstable physical disorders (cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic); or any physical disorder judged to significantly affect central nervous system function.
- •Patients meeting criteria for the following DSM-IV diagnoses: organic mental disorders; substance use disorders, including alcohol, active within the last 6 months; bipolar disorder; schizoaffective disorder; or antisocial personality disorder.
- •Patients who are currently taking an antidepressant, antipsychotic, or mood stabilizing drug and who are responding to one or all of these medications. If patients are not responding to these medications, they may go through a washout period of at least one week under the supervision of a study doctor before entering into this study.
- •Patients who are not able to read and understand the consent form, or who are not capable of understanding or giving informed consent to the procedures of the study
研究组 & 干预措施
Major Depression with Psychotic Features
干预措施: Aripiprazole (Drug)
结局指标
主要结局
Depression and Psychosis Response Rate
时间窗: Baseline and 7 weeks
This response rate refers to the percentage of patients who experienced a 50 percent or greater reduction in symptoms. Specifically, this refers to a 50 percent reduction in Hamilton Depression Rating Scale 17 (HAM-D-17) scores from baseline and no psychotic symptoms as measured by the Structured Clinical Interview for DMS-IV psychosis module. HAM-D-17 scores range from 0-50 with a score of \>23 considered severely depressed and \<7 to be mildly to not at all depressed.
次要结局
- Depression and Psychosis Remission Rate(Baseline and 7 weeks)
研究者
John D. Matthews
Principal Investigator
Massachusetts General Hospital