Early Integrated Intervention in Severe Affective Disorders

• Sponsor: Hovedstadens Sygehusfaelesskab (Other)
• Overall Status: Completed
• CT.gov ID: NCT00253071
• Collaborator: Rigshospitalet, Denmark (Other), Hvidovre University Hospital (Other), Amager Hospital (Other), Frederiksberg University Hospital (Other), Bispebjerg Hospital (Other)
• Enrollment: 426
• Location: 1
• Arms: 2
• Duration (Months): 75
• Patients Per Site Per Month: 5.7

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Depressive Disorder; Bipolar Disorder	Behavioral: Prophylactic combined medical and psychological treatment	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 426 participants
• 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.
• Study Start Date: Dec 1, 2005
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Time to re-admission [0-6 years]

Secondary Outcome Measures

1. Time to recurrence of an affective episode (depressive (MDI) or manic/mixed (MDQ)). [1 and 2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lars Vedel Kessing, Professor, MD, Hovedstadens Sygehusfaelesskab
• ClinicalTrials.gov Identifier: NCT00253071
• Other Study ID Numbers: 31/04r
• First Posted: Nov 15, 2005
• Last Update Posted: Mar 19, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Lars Vedel Kessing, Professor, MD, Hovedstadens Sygehusfaelesskab: Prophylactic treatment; Pharmacological treatment; Psychological treatment
• Additional relevant MeSH terms: Disease; Depressive Disorder; Bipolar Disorder; Mood Disorders

Study Results

No Results Posted as of Mar 19, 2015