跳至主要内容
临床试验/NCT00253071
NCT00253071已完成不适用

Early Integrated Intervention in Severe Affective Disorders - a Randomized Controlled Trial.

Hovedstadens Sygehusfaelesskab2 个研究点 分布在 1 个国家目标入组 426 人开始时间: 2005年12月1日最近更新:
适应症

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

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

发起方
Hovedstadens Sygehusfaelesskab
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lars Vedel Kessing

Professor, MD

Hovedstadens Sygehusfaelesskab

研究点 (2)

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