Early Integrated Intervention in Severe Affective Disorders

This study has been completed.
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Hvidovre University Hospital
Amager Hospital
Frederiksberg University Hospital
Bispebjerg Hospital
Information provided by (Responsible Party):
Lars Vedel Kessing, Hovedstadens Sygehusfaelesskab
ClinicalTrials.gov Identifier:
NCT00253071
First received: November 14, 2005
Last updated: March 17, 2012
Last verified: March 2012

November 14, 2005
March 17, 2012
December 2005
March 2012   (final data collection date for primary outcome measure)
Time to re-admission [ Time Frame: 0-6 years ] [ Designated as safety issue: No ]
Time to rehospitalisation to a psychiatric ward (registerbased)
Complete list of historical versions of study NCT00253071 on ClinicalTrials.gov Archive Site
Time to recurrence of an affective episode (depressive (MDI) or manic/mixed (MDQ)). [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
Time to recurrence of an affective episode (depressive (MDI) or manic/mixed (MDQ)).
Not Provided
Not Provided
 
Early Integrated Intervention in Severe Affective Disorders
Early Integrated Intervention in Severe Affective Disorders - a Randomized Controlled Trial.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Depressive Disorder
  • Bipolar Disorder
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.

  • No Intervention: A,2
    No intervention: treatment as usual at a community psychiatric center, private psychiatrist or general practitioner.
    Intervention: Behavioral: Prophylactic combined medical and psychological treatment
  • Experimental: A, 1

    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.

    Intervention: Behavioral: Prophylactic combined medical and psychological treatment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
426
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00253071
31/04r
No
Lars Vedel Kessing, Hovedstadens Sygehusfaelesskab
Hovedstadens Sygehusfaelesskab
  • Rigshospitalet, Denmark
  • Hvidovre University Hospital
  • Amager Hospital
  • Frederiksberg University Hospital
  • Bispebjerg Hospital
Principal Investigator: Lars V kessing, Professor Department of psychiatry, University Hospital of Copenhagen, Denmark
Hovedstadens Sygehusfaelesskab
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP