Early Integrated Intervention in Severe Affective Disorders - a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 426
- 试验地点
- 2
- 主要终点
- Time to re-admission
研究概览
简要总结
The purpose of this study is to determine whether early integrated prophylactic combined medical and psychological outpatient treatment is associated with a better prognosis in patients with severe unipolar and bipolar affective disorders than standard treatment.
详细描述
Patients who have been hospitalised for unipolar or bipolar disorder have a poor prognosis with highly increased risk of recurrence of episodes and increased risk of psychosocial dysfunction. It seems as integrated prophylactic combined medical and psychological out-patient treatment may lead to a better long-term prognosis in patients with affective disorders in general. It has not been specifically investigated whether such integrated treatment may improve long-term outcome if the intervention is offered early in the course of the affective illness.
Subjects: Patients currently discharged from first, second or third hospitalisation ever from psychiatric department with a diagnosis of severe single depressive episode/recurrent depression or with a diagnosis of manic/mixed episode or bipolar disorder.
Comparison: Early intervention with integrated prophylactic combined medical and psychological outpatient treatment as offered by a clinic for affective disorders compared with standard outpatient treatment as offered by community psychiatric centres, private specialists in psychiatry or general practitioners.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Discharge diagnosis of severe single depressive episode, recurrent depression, manic/mixed episode or bipolar disorder
排除标准
- •Moderate to severe dementia
- •Incapable in understanding or reading danish
- •Earlier randomised to the trial
结局指标
主要结局
Time to re-admission
时间窗: 0-6 years
次要结局
- Time to recurrence of an affective episode (depressive (MDI) or manic/mixed (MDQ)).(1 and 2 years)
研究者
Lars Vedel Kessing
Professor, MD
Hovedstadens Sygehusfaelesskab
