Depressive DisorderNCT00253071
Early Integrated Intervention in Severe Affective Disorders
A study testing Prophylactic combined medical and psychological treatment in people with Depressive Disorder and Bipolar Disorder, run by Hovedstadens Sygehusfaelesskab at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depressive Disorder, Bipolar Disorder
- What is being tested?
- Prophylactic combined medical and psychological treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 426 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2005to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Discharge diagnosis of severe single depressive episode, recurrent depression, manic/mixed episode or bipolar disorder
Who cannot join
- Moderate to severe dementia
- Incapable in understanding or reading danish
- Earlier randomised to the trial
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Psychiatry, University Hospital of Copenhagen, Denmark
Copenhagen, 2100
About this study
Official title: Early Integrated Intervention in Severe Affective Disorders - a Randomized Controlled Trial.
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.
Read the 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.
- Conditions
- Depressive Disorder, Bipolar Disorder
- Being tested
- Prophylactic combined medical and psychological treatment
- Keywords
- Prophylactic treatment, Pharmacological treatment, Psychological treatment
- Medical subject headings
- Depressive Disorder, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic combined medical and psychological treatmentBehavioural
Medical treatment is naturalistic and evidence based according to international recommendations.
Psychological treatment is either group psychoeducation or group cognitive behavioural therapy.
| Study group | Role | What they receive |
|---|---|---|
| A,2 | Active comparator | Standard treatment: treatment as usual at a community psychiatric center, private psychiatrist or general practitioner. Receives: Behavioral: Prophylactic combined medical and psychological treatment |
| A, 1 | Experimental | 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. Receives: Behavioral: Prophylactic combined medical and psychological treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to re-admission
Measured: 0-6 years
Secondary outcomes (1)
Time to recurrence of an affective episode (depressive (MDI) or manic/mixed (MDQ)).
Measured: 1 and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startDec 2005
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hovedstadens Sygehusfaelesskab
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Hvidovre University Hospital, Amager Hospital, Frederiksberg University Hospital, Bispebjerg Hospital
- Responsible party
- Principal investigator, Lars Vedel Kessing, Hovedstadens Sygehusfaelesskab
- Investigators
- Lars V kessing, Professor, Principal investigator, Department of psychiatry, University Hospital of Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253071
- Sponsor's protocol ID
- 31/04r
- Status last verified
- Mar 2015
- First submitted
- 14 Nov 2005
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Munkholm K, Kessing LV. Early specialised treatment for bipolar disorder: Long-term follow-up from the early intervention in affective disorders (EIA) randomised controlled trial. Acta Psychiatr Scand. 2024 Sep;150(3):138-147. doi: 10.1111/acps.13716. Epub 2024 Jun 2.
PubMed 38825333Kessing 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.
PubMed 24268595Kessing 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.
PubMed 23349295Hansen 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.
PubMed 22442673Kessing 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.
PubMed 21291564
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Integrated Intervention in Severe Affective Disorders - a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00253071
- Acronym / sponsor ID
- 31/04r
- Conditions
- Depressive Disorder, Bipolar Disorder
- Keywords
- Prophylactic treatment, Pharmacological treatment, Psychological treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Hovedstadens SygehusfaelesskabUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Hvidovre University Hospital, Amager Hospital, Frederiksberg University Hospital, Bispebjerg Hospital
- Study start
- Dec 2005
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 15 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A,2 | Active comparator | Behavioral: Prophylactic combined medical and psychological treatmentStandard treatment: treatment as usual at a community psychiatric center, private psychiatrist or general practitioner. |
| A, 1 | Experimental | Behavioral: Prophylactic combined medical and psychological treatmentBehavioral: 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Discharge diagnosis of severe single depressive episode, recurrent depression, manic/mixed episode or bipolar disorder
Key exclusion criteria (3 listed)
- Moderate to severe dementia
- Incapable in understanding or reading danish
- Earlier randomised to the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prophylactic combined medical and psychological treatmentMedical treatment is naturalistic and evidence based according to international recommendations. Psychological treatment is either group psychoeducation or group cognitive behavioural therapy. | Behavioural | A, 1, A,2 |
Primary outcome
Time to re-admission
Time frame: 0-6 years
1 secondary outcome
Time to recurrence of an affective episode (depressive (MDI) or manic/mixed (MDQ)).
Time frame: 1 and 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
- Derived from this study: PubMed 38825333Munkholm K, Kessing LV. Early specialised treatment for bipolar disorder: Long-term follow-up from the early intervention in affective disorders (EIA) randomised controlled trial. Acta Psychiatr Scand. 2024 Sep;150(3):138-147. doi: 10.1111/acps.13716. Epub 2024 Jun 2.
- Derived from this study: PubMed 24268595Kessing 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.
- Derived from this study: PubMed 23349295Kessing 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.
- Derived from this study: PubMed 22442673Hansen 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.
- Derived from this study: PubMed 21291564Kessing 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars V kessing, Professor principal investigator
Department of psychiatry, University Hospital of Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic combined medical and psychological treatment in people with Depressive Disorder and Bipolar Disorder, run by Hovedstadens Sygehusfaelesskab at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to re-admission (time frame: 0-6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00253071, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2015.