Early Integrated Intervention in Severe Affective Disorders

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00253071
• Other study ID #: 31/04r
• Status: Completed
• Phase: N/A
• First received: November 14, 2005
• Last updated: March 18, 2015
• Start date: December 2005
• Est. completion date: March 2012

Study information

• Verified date: March 2015
• Source: Hovedstadens Sygehusfaelesskab
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Disease
• Mood Disorders

Intervention

Behavioral:
• Prophylactic combined medical and psychological treatment
Medical treatment is naturalistic and evidence based according to international recommendations. Psychological treatment is either group psychoeducation or group cognitive behavioural therapy.

Locations

Country	Name	City	State
Denmark	Department of Psychiatry, University Hospital of Copenhagen, Denmark	Copenhagen

Sponsors (6)

Lead Sponsor	Collaborator
Hovedstadens Sygehusfaelesskab	Amager Hospital, Bispebjerg Hospital, Frederiksberg University Hospital, Hvidovre University Hospital, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to re-admission		0-6 years	No
Secondary	Time to recurrence of an affective episode (depressive (MDI) or manic/mixed (MDQ)).		1 and 2 years	No