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Early Integrated Intervention in Severe Affective Disorders

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00253071
First Posted: November 15, 2005
Last Update Posted: March 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Rigshospitalet, Denmark
Hvidovre University Hospital
Amager Hospital
Frederiksberg University Hospital
Bispebjerg Hospital
Information provided by (Responsible Party):
Lars Vedel Kessing, Hovedstadens Sygehusfaelesskab
  Purpose
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.

Condition Intervention
Depressive Disorder Bipolar Disorder Behavioral: Prophylactic combined medical and psychological treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Integrated Intervention in Severe Affective Disorders - a Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Lars Vedel Kessing, Hovedstadens Sygehusfaelesskab:

Primary Outcome Measures:
  • Time to re-admission [ Time Frame: 0-6 years ]

Secondary Outcome Measures:
  • Time to recurrence of an affective episode (depressive (MDI) or manic/mixed (MDQ)). [ Time Frame: 1 and 2 years ]

Enrollment: 426
Study Start Date: December 2005
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A,2
Standard treatment: treatment as usual at a community psychiatric center, private psychiatrist or general practitioner.
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.

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.

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.


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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00253071


Locations
Denmark
Department of Psychiatry, University Hospital of Copenhagen, Denmark
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Hovedstadens Sygehusfaelesskab
Rigshospitalet, Denmark
Hvidovre University Hospital
Amager Hospital
Frederiksberg University Hospital
Bispebjerg Hospital
Investigators
Principal Investigator: Lars V kessing, Professor Department of psychiatry, University Hospital of Copenhagen, Denmark
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lars Vedel Kessing, Professor, MD, Hovedstadens Sygehusfaelesskab
ClinicalTrials.gov Identifier: NCT00253071     History of Changes
Other Study ID Numbers: 31/04r
First Submitted: November 14, 2005
First Posted: November 15, 2005
Last Update Posted: March 19, 2015
Last Verified: March 2015

Keywords provided by Lars Vedel Kessing, Hovedstadens Sygehusfaelesskab:
Prophylactic treatment
Pharmacological treatment
Psychological treatment

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Bipolar Disorder
Mood Disorders
Pathologic Processes
Mental Disorders
Behavioral Symptoms
Bipolar and Related Disorders