Depression: The Search for Treatment-Relevant Phenotypes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 2
- 主要终点
- Hamilton Rating Scale for Depression score
研究概览
简要总结
This study will determine how certain features of depressed individuals affect their responses to depression treatment.
详细描述
Major depression is a serious condition that can have devastating functional consequences. Although numerous depression studies have been conducted, understanding of how best to achieve long-term recovery remains limited. This study will assess the mood, personality, pharamcokinetic and genetic characteristics of depressed participants to determine the effects of these features on treatment response.
This study will be conducted at two international treatment sites, including the University of Pittsburgh and the University of Pisa, Italy. Participants will be randomly assigned to receive either interpersonal psychotherapy (IPT) or escitalopram pharmacotherapy for a minimum of 32 weeks or approximately 8 months. Participants whose symptoms become stabilized will continue the initial treatment for another 6 months; those who do not will have the second treatment added to their regimen until remission occurs. Clinical evaluations and questionnaires will be used to assess participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Major depression
排除标准
- •History of manic or hypomanic episodes
- •History of schizophrenia or schizoaffective disorder
- •Diagnosis of anorexia nervosa or bulimia nervosa
- •Current psychosis
- •Drug and/or alcohol dependence or abuse within 3 months prior to study entry. Participants with episodic abuse related to mood disorders will not be excluded.
- •Diagnosis of antisocial personality disorder
- •Diagnosis of organic affective syndrome and uncontrolled medical illness
- •Pregnancy
- •Require inpatient treatment for suicidal risk or psychosis
- •History of an inability to tolerate any of the study treatments
- •Currently receiving treatment with an effective antidepressant
研究组 & 干预措施
1
Interpersonal Psychotherapy
干预措施: Interpersonal Psychotherapy (Behavioral)
2
Escitalopram
干预措施: Escitalopram (Drug)
3
Escitalopram plus IPT
干预措施: Escitalopram plus IPT (Other)
结局指标
主要结局
Hamilton Rating Scale for Depression score
时间窗: Measured at Months 8 and 14
Treatment-relevant phenotypes of depression
时间窗: Measured at Months 8 and 14
次要结局
未报告次要终点