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
|
Purpose
| 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.
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
Inclusion Criteria:
1. 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
- retspsykiatrisk dom
- tvang ihht. psykiatriloven
- Earlier randomised to the trial
Location and Contact Information
Ellen Margrethe Christensen, M.D. 45 35456264
Denmark
Department of Psychiatry, University Hospital of Copenhagen, Denmark, Copenhagen, 2100, Denmark
Ellen Margrethe Christensen, M.D. 45 35456264
Lars V Kessing, Professor, Principal Investigator
Lars V kessing, Professor, Principal Investigator, Department of psychiatry, University Hospital of Copenhagen, Denmark
More Information
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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