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Clinical Trials/NCT00253071
NCT00253071
Completed
Not Applicable

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

Hovedstadens Sygehusfaelesskab1 site in 1 country426 target enrollmentDecember 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depressive Disorder
Sponsor
Hovedstadens Sygehusfaelesskab
Enrollment
426
Locations
1
Primary Endpoint
Time to re-admission
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 2005
End Date
March 2012
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hovedstadens Sygehusfaelesskab
Responsible Party
Principal Investigator
Principal Investigator

Lars Vedel Kessing

Professor, MD

Hovedstadens Sygehusfaelesskab

Eligibility Criteria

Inclusion Criteria

  • Discharge diagnosis of severe single depressive episode, recurrent depression, manic/mixed episode or bipolar disorder

Exclusion Criteria

  • Moderate to severe dementia
  • Incapable in understanding or reading danish
  • Earlier randomised to the trial

Outcomes

Primary Outcomes

Time to re-admission

Time Frame: 0-6 years

Secondary Outcomes

  • Time to recurrence of an affective episode (depressive (MDI) or manic/mixed (MDQ)).(1 and 2 years)

Study Sites (1)

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