Early Integrated Intervention in Severe Affective Disorders

Not Applicable

Completed

• Conditions: Bipolar Disorder; Depressive Disorder

• Registration Number: NCT00253071
• Lead Sponsor: Hovedstadens Sygehusfaelesskab

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.

Study Timeline

• Study First Submitted: 2005-11-14
• Study First Submitted QC: 2005-11-14
• Study First Posted: 2005-11-15
• Study Start: 2005-12
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-18
• Last Update Posted: 2015-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 426

Inclusion Criteria

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

Exclusion Criteria

1. Moderate to severe dementia
2. Incapable in understanding or reading danish
3. Earlier randomised to the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to re-admission	0-6 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Psychiatry, University Hospital of Copenhagen, Denmark; 🇩🇰 Copenhagen, Denmark