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Early Integrated Intervention in Severe Affective Disorders. - Article


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X-linked severe combined immunodeficiency

SCIDX1; X-SCID; XSCID


Clinical Trial: Early Integrated Intervention in Severe Affective Disorders.

This study is not yet open for patient recruitment.
Verified by Hovedstadens Sygehusfaelesskab November 2005

Sponsors and Collaborators: Hovedstadens Sygehusfaelesskab
Rigshospitalet, Denmark
Hvidovre University Hospital
Amager Hospital
Frederiksberg University Hospital
Bispebjerg Hospital
Information provided by: Hovedstadens Sygehusfaelesskab
ClinicalTrials.gov Identifier: NCT00253071

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
 Behavior: Prophylactic combined medical and psychological treatment

MedlinePlus related topics:  Bipolar Disorder;   Mental Health

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

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

Further study details as provided by Hovedstadens Sygehusfaelesskab:
Primary Outcomes: Time to rehospitalisation to a psychiatric ward (registerbased)
Secondary Outcomes: Time to recurrence of an affective episode (depressive (MDI) or manic/mixed (MDQ)).
Expected Total Enrollment:  360

Study start: December 2005;  Expected completion: September 2011
Last follow-up: December 2010;  Data entry closure: March 2011

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

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both
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. retspsykiatrisk dom
  4. tvang ihht. psykiatriloven
  5. Earlier randomised to the trial

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00253071

Lars V Kessing, Professor      45 35456237    lars.kessing@rh.dk
Ellen Margrethe Christensen, M.D.      45 35456264 

Denmark
      Department of Psychiatry, University Hospital of Copenhagen, Denmark, Copenhagen,  2100,  Denmark
Lars V Kessing, Professor  45 35456237    lars.kessing@rh.dk 
Ellen Margrethe Christensen, M.D.  45 35456264 
Lars V Kessing, Professor,  Principal Investigator

Study chairs or principal investigators

Lars V kessing, Professor,  Principal Investigator,  Department of psychiatry, University Hospital of Copenhagen, Denmark   

More Information

Study ID Numbers:  31/04r
Last Updated:  December 8, 2005
Record first received:  November 14, 2005
ClinicalTrials.gov Identifier:  NCT00253071
Health Authority: Denmark: National Board of Health
ClinicalTrials.gov processed this record on 2006-01-10


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Page Updated: September 6, 2005
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