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Completed

NCT Number: NCT00253071

Early Integrated Intervention in Severe Affective Disorders

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.

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Key information

Conditions

Depressive Disorder Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, University Hospital of Copenhagen, Denmark

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prophylactic combined medical and psychological treatment

Behavioral

Medical treatment is naturalistic and evidence based according to international recommendations.

Psychological treatment is either group psychoeducation or group cognitive behavioural therapy.

Primary outcomes

  1. Time to re-admission

    Time frame: 0-6 years

Secondary outcomes

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

    Time frame: 1 and 2 years

Sponsors and collaborators

Lead sponsor

Hovedstadens Sygehusfaelesskab

Other

Collaborators

  • Amager Hospital
  • Bispebjerg Hospital
  • Frederiksberg University Hospital
  • Hvidovre University Hospital
  • Rigshospitalet, Denmark

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2012
Study completion
2012
First posted
Nov 15, 2005
Registry last updated
Mar 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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