DepressionPRODEFARNCT00794196
Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care
A study testing Pharmaceutical care program for antidepressant treatment in people with Depression, run by Fundació Sant Joan de Déu at 2 sites in Spain.
Trial summary
The purpose of this study is to evaluate the impact of pharmaceutical services among patients starting a treatment with antidepressants for a diagnosis of depression. The hypothesis of the study is that pharmacist intervention can improve compliance to antidepressants and patient wellbeing. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depression
- What is being tested?
- Pharmaceutical care program for antidepressant treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 2 sitesSpain
- Study dates
- Oct 2008to Nov 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis for depression from a general practitioner
- Beginning a pharmacological antidepressant treatment
- Going to one of the participant community pharmacies
Who cannot join
- Used antidepressant medication in the past 2 months
- Had an appointment with an specialist in mental disorders in the past 2 months
- History of psychotic or bipolar episodes
- History of drug abuse or dependency
- Cognitive impairment that not allows assessment
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Primary Care Center Doctor Bartomeu Fabres Anglada
Gavà, Barcelona, 08850
Primary Care Center Gavà 1
Gavà, Barcelona, 08850
About this study
Official title: Impact of the Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care on the Compliance to Antidepressants and Patient Wellbeing
The purpose of this study is to evaluate the impact of pharmaceutical services among patients starting a treatment with antidepressants for a diagnosis of depression. The hypothesis of the study is that pharmacist intervention can improve compliance to antidepressants and patient wellbeing.
Read the detailed description
The aim of this study is to evaluate the efficacy of a support program in community pharmacy on the improvement of the compliance to antidepressants and the clinic of typical primary care patients under normal practice circumstances. That implies that the intervention is made by pharmacists without any specific requirement that work in the community pharmacies set up in the area of study and on patients following the usual medical circuit. As well, the cost of the support program is calculated in order to set the effectiveness of the program.
- Conditions
- Depression
- Being tested
- Pharmaceutical care program for antidepressant treatment
- Keywords
- Medication adherence, Antidepressive agents, Primary care, Pharmaceutical care
- Medical subject headings
- Depression, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical care program for antidepressant treatmentBehavioural
Also called PRODEFAR group
The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | The control group will be receiving usual medical and pharmaceutical care. |
| Intervention Group | Experimental | Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program. Receives: Behavioral: Pharmaceutical care program for antidepressant treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Antidepressant Medication
Adherence to antidepressant medication was measured through Pharmacy records
Measured: At 3 and 6 months
Secondary outcomes (1)
Patient Wellbeing
Patient wellbeing EUROQOL5D scale is used to evaluate health-related quality of life.
The answers given to EUROQOL5D allow for the description 243 unique health states which can be converted into EQ-5D index anchored at 0 for death and 1 for perfect health.
Measured: 0, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionNov 2011
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute, Catalan Institute of Health, University of Barcelona
- Responsible party
- Principal investigator, Antoni Serrano Blanco, Fundació Sant Joan de Déu
- Investigators
- Antoni Serrano, MD PhD, Principal investigator, Foundation Sant Joan de Deu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794196
- Sponsor's protocol ID
- FIS PI070546
- Acronym
- PRODEFAR
- Status last verified
- Oct 2016
- First submitted
- 17 Nov 2008
- Last updated
- 22 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rubio-Valera M, Bosmans J, Fernandez A, Penarrubia-Maria M, March M, Trave P, Bellon JA, Serrano-Blanco A. Cost-effectiveness of a community pharmacist intervention in patients with depression: a randomized controlled trial (PRODEFAR Study). PLoS One. 2013 Aug 12;8(8):e70588. doi: 10.1371/journal.pone.0070588. eCollection 2013.
PubMed 23950967Rubio-Valera M, Serrano-Blanco A, Trave P, Penarrubia-Maria MT, Ruiz M, Pujol MM. Community pharmacist intervention in depressed primary care patients (PRODEFAR study): randomized controlled trial protocol. BMC Public Health. 2009 Aug 5;9:284. doi: 10.1186/1471-2458-9-284.
PubMed 19656386
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care on the Compliance to Antidepressants and Patient Wellbeing
- ClinicalTrials.gov ID
- NCT00794196
- Acronym / sponsor ID
- PRODEFAR / FIS PI070546
- Conditions
- Depression
- Keywords
- Medication adherence, Antidepressive agents, Primary care, Pharmaceutical care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- Carlos III Health Institute, Catalan Institute of Health, University of Barcelona
- Study start
- Oct 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 19 Nov 2008 (estimated)
- Results
- Posted 15 Aug 2016
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 evaluate the impact of pharmaceutical services among patients starting a treatment with antidepressants for a diagnosis of depression. The hypothesis of the study is that pharmacist intervention can improve compliance to antidepressants and patient wellbeing.
Detailed description
The aim of this study is to evaluate the efficacy of a support program in community pharmacy on the improvement of the compliance to antidepressants and the clinic of typical primary care patients under normal practice circumstances. That implies that the intervention is made by pharmacists without any specific requirement that work in the community pharmacies set up in the area of study and on patients following the usual medical circuit. As well, the cost of the support program is calculated in order to set the effectiveness of the program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –The control group will be receiving usual medical and pharmaceutical care. |
| Intervention Group | Experimental | Behavioral: Pharmaceutical care program for antidepressant treatmentIntervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis for depression from a general practitioner
- Beginning a pharmacological antidepressant treatment
- Going to one of the participant community pharmacies
Key exclusion criteria (5 listed)
- Used antidepressant medication in the past 2 months
- Had an appointment with an specialist in mental disorders in the past 2 months
- History of psychotic or bipolar episodes
- History of drug abuse or dependency
- Cognitive impairment that not allows assessment
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 |
|---|---|---|
| Pharmaceutical care program for antidepressant treatmentAlso: PRODEFAR groupThe pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment. | Behavioural | Intervention Group |
Primary outcome
Adherence to Antidepressant Medication
Time frame: At 3 and 6 months
Adherence to antidepressant medication was measured through Pharmacy records
1 secondary outcome
Patient Wellbeing
Time frame: 0, 3 and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23950967Rubio-Valera M, Bosmans J, Fernandez A, Penarrubia-Maria M, March M, Trave P, Bellon JA, Serrano-Blanco A. Cost-effectiveness of a community pharmacist intervention in patients with depression: a randomized controlled trial (PRODEFAR Study). PLoS One. 2013 Aug 12;8(8):e70588. doi: 10.1371/journal.pone.0070588. eCollection 2013.
- Derived from this study: PubMed 19656386Rubio-Valera M, Serrano-Blanco A, Trave P, Penarrubia-Maria MT, Ruiz M, Pujol MM. Community pharmacist intervention in depressed primary care patients (PRODEFAR study): randomized controlled trial protocol. BMC Public Health. 2009 Aug 5;9:284. doi: 10.1186/1471-2458-9-284.
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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.
Antoni Serrano, MD PhD principal investigator
Foundation Sant Joan de Deu
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmaceutical care program for antidepressant treatment in people with Depression, run by Fundació Sant Joan de Déu at 2 sites in Spain.
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 3 inclusion and 5 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 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Yes. Results are posted in the registry (first posted 15 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adherence to Antidepressant Medication (time frame: At 3 and 6 months). 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 NCT00794196, which also lists 2 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 22 Nov 2016.