This trial is active, not recruiting.

Condition depression
Treatment pharmaceutical care program for antidepressant treatment
Sponsor Fundació Sant Joan de Déu
Collaborator Carlos III Health Institute
Start date October 2008
End date October 2011
Trial size 200 participants
Trial identifier NCT00794196, FIS PI070546


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose supportive care
(No Intervention)
The control group will be receiving usual medical and pharmaceutical care.
Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.
pharmaceutical care program for antidepressant treatment PRODEFAR group
The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment.

Primary Outcomes

Adherence to antidepressant medication
time frame: At 3 and 6 months

Secondary Outcomes

Patient wellbeing
time frame: 0, 3 and 6 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Clinical diagnosis for depression from a general practitioner - Beginning a pharmacological antidepressant treatment - Going to one of the participant community pharmacies Exclusion Criteria: - 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

Additional Information

Official title Impact of the Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care on the Compliance to Antidepressants and Patient Wellbeing
Principal investigator Antoni Serrano, MD PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by Fundació Sant Joan de Déu.