Early Integrated Intervention in Severe Affective Disorders
| Tracking Information | |||||
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| First Received Date ICMJE | November 14, 2005 | ||||
| Last Updated Date | March 17, 2012 | ||||
| Start Date ICMJE | December 2005 | ||||
| Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Time to re-admission [ Time Frame: 0-6 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Time to rehospitalisation to a psychiatric ward (registerbased) | ||||
| Change History | Complete list of historical versions of study NCT00253071 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Time to recurrence of an affective episode (depressive (MDI) or manic/mixed (MDQ)). [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Time to recurrence of an affective episode (depressive (MDI) or manic/mixed (MDQ)). | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Early Integrated Intervention in Severe Affective Disorders | ||||
| Official Title ICMJE | Early Integrated Intervention in Severe Affective Disorders - a Randomized Controlled Trial. | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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. |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 426 | ||||
| Completion Date | March 2012 | ||||
| Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: 1. Discharge diagnosis of severe single depressive episode, recurrent depression, manic/mixed episode or bipolar disorder Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00253071 | ||||
| Other Study ID Numbers ICMJE | 31/04r | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Lars Vedel Kessing, Hovedstadens Sygehusfaelesskab | ||||
| Study Sponsor ICMJE | Hovedstadens Sygehusfaelesskab | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Hovedstadens Sygehusfaelesskab | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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