Condition category
Mental and Behavioural Disorders
Date applied
27/11/2007
Date assigned
18/12/2007
Last edited
18/12/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr María Isabel Fernández San Martín

ORCID ID

Contact details

Lope de Vega 138
Barcelona
08005
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PI061281

Study information

Scientific title

Acronym

MADEIRA

Study hypothesis

1. The average depressive symptoms at the end of six months of follow-up among the group of depression patients treated by the primary care nurse and the group treated by the family doctor do not exceed the difference of 2.5 on the BDI scale, which is considered a difference not clinically relevant.
2. There will be no significant difference in change in the quality of life between the two groups.
3. Level of satisfaction will be similar in both groups, or greater among patients followed by nurses than the participants who are treated by the doctors
4. Adherence to treatment will be similar in both groups, or higher in patients followed by the nurses

Ethics approval

Approved by the Research Ethics Committee of the Jordi Gol i Gurina Primary Care Research Institute (IDIAP), Barcelona, on 4 July 2006 (ref: P06/39)

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Major depression

Intervention

Half of the participants will be allocated to the intervention group and another half into the control group. This trial involves 23 doctors and 23 nurses from 12 primary care teams in Barcelona.

Intervention group: Implementation of a depression management protocol, based on evidence-based clinical guidelines, by the primary care nurse. This protocol includes pharmacological treatment with fluoxetine or another Selective Serotonin Re-uptake Inhibitor (SSRI), and the participants will have at least 6 appointments with the nurses during the 6 months of follow-up. At each visit, each patient will be informed about the disease and pharmacological treatment. In addition, the nurse will ask the patient about changes in mood and try to enhance compliance. Nurses will also provide emotional support. If the patient does not improve, he will be referred to his doctor.

Control group: Six-month follow-up by family doctors. Family doctors will provides usual care management. They can prescribe fluoxetine or another SSRI. Participants will have at least 6 appointments with their doctor during the 6 months of follow-up.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Differences between groups in the average of decrease in depression symptoms, measured by BDI at 6 months
2. Increase in quality of life, measured by the 12-item Short Form health survey (SF-12) at 6 months
3. Increase in satisfaction with the professional, measured by the satisfaction questionnaire of Baker at 6 months

Secondary outcome measures

1. Percentage of acceptance of the intervention (comparison of the two groups): patient satisfaction and losses that occur at different times of follow-up
2. Average of differences between the two groups with respect to:
2.1. Frequency and duration of visits
2.2. Referrals
2.3. Drug treatment
3. Comparison of adherence to treatment between the two groups

Overall trial start date

01/01/2008

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients between 25 and 70 years of age
2. Rating of 20 or more points in the Beck Depression Inventory Scale (BDI)
3. Whose family practitioner thinks they suffer from depression and they need to initiate anti-depressant treatment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

460

Participant exclusion criteria

1. Pregnancy or breastfeeding
2. Background of severe psychiatric disorders: psychosis, paranoia, severe personality disorders, delusional thoughts
3. Existence of suicidal ideation or attempts
4. Two or more episodes of major depression, or one or more episodes that might require hospitalization
5. Patients who have received antidepressant medication in the past year
6. Patients with mental health problems who have been referred to psychiatric specialists for these reasons
7. Substance abuse and/or drugs
8. Treatment for Parkinson's disease or epilepsy
9. Temporal residents (plan to move in the next six months)
10. Unable to communicate in Spanish or Catalan languages

Recruitment start date

01/01/2008

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Spain

Trial participating centre

Lope de Vega 138
Barcelona
08005
Spain

Sponsor information

Organisation

Jordi Gol i Gurina Primary Care Research Institute (IDIAP Jordi Gol i Gurina) (Spain)

Sponsor details

Gran Via de les Corts Catalanes
587 àtic
Barcelona
08007
Spain

Sponsor type

Government

Website

http://www.idiapjgol.org/

Funders

Funder type

Government

Funder name

Carlos III Health Institute of the Spanish Ministry of Health and Consumption (Fondo de Investigación Sanitaria, Instituto de Salud Carlos III, Ministerio de Sanidad y Consumo), Health Research Fund (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes