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
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