Early Integrated Intervention in Severe Affective Disorders
NCT ID: NCT00253071
Last Updated: 2015-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
426 participants
INTERVENTIONAL
2005-12-31
2012-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Assertive Community Treatment in Copenhagen
NCT00225602
Improving Work Outcome for People With Severe Mental Illness
NCT01722344
Cognitive Training to Improve Work Outcomes in Severe Mental Illness
NCT00895258
Detection and Treatment of Depression in Patients Admitted to the General Hospital
NCT00521911
Implementation Trial of Evidence Based Practices for Mood Disorders
NCT02150577
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A,2
Standard treatment: treatment as usual at a community psychiatric center, private psychiatrist or general practitioner.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
2. Incapable in understanding or reading danish
3. Earlier randomised to the trial
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rigshospitalet, Denmark
OTHER
Hvidovre University Hospital
OTHER
Amager Hospital
OTHER
Frederiksberg University Hospital
OTHER
Bispebjerg Hospital
OTHER
Hovedstadens Sygehusfaelesskab
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Lars Vedel Kessing
Professor, MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lars V kessing, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of psychiatry, University Hospital of Copenhagen, Denmark
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Psychiatry, University Hospital of Copenhagen, Denmark
Copenhagen, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kessing LV, Hansen HV, Christensen EM, Dam H, Gluud C, Wetterslev J; Early Intervention Affective Disorders (EIA) Trial Group. Do young adults with bipolar disorder benefit from early intervention? J Affect Disord. 2014 Jan;152-154:403-8. doi: 10.1016/j.jad.2013.10.001. Epub 2013 Oct 10.
Kessing LV, Hansen HV, Hvenegaard A, Christensen EM, Dam H, Gluud C, Wetterslev J; Early Intervention Affective Disorders (EIA) Trial Group. Treatment in a specialised out-patient mood disorder clinic v. standard out-patient treatment in the early course of bipolar disorder: randomised clinical trial. Br J Psychiatry. 2013 Mar;202(3):212-9. doi: 10.1192/bjp.bp.112.113548. Epub 2013 Jan 24.
Hansen HV, Christensen EM, Dam H, Gluud C, Wetterslev J, Kessing LV; Early Intervention Affective Disorders (EIA) Trial Group. The effects of centralised and specialised intervention in the early course of severe unipolar depressive disorder: a randomised clinical trial. PLoS One. 2012;7(3):e32950. doi: 10.1371/journal.pone.0032950. Epub 2012 Mar 19.
Kessing LV, Hansen HV, Christensen EM, Dam H, Gluud C, Wetterslev J; Early Intervention Affective Disorders (EIA) Group. The effects of centralised and specialised combined pharmacological and psychological intervention compared with decentralised and non-specialised treatment in the early course of severe unipolar and bipolar affective disorders--design of two randomised clinical trials. Trials. 2011 Feb 3;12:32. doi: 10.1186/1745-6215-12-32.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
31/04r
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.