Clinical trial NCT00794196: Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care
Official title: Impact of the Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care on the Compliance to Antidepressants and Patient Wellbeing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Medication adherence
Antidepressive agents
Primary care
Pharmaceutical care
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Carlos III Health Institute
name: Catalan Institute of Health
name: University of Barcelona
First posted: 2008-11-19
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to Antidepressant Medication
timeFrame: At 3 and 6 months
Secondary outcomes:
measure: Patient Wellbeing
timeFrame: 0, 3 and 6 months
Other outcomes:
Locations:
city: Gava
country: Spain
facility: Primary Care Center Gavà 1
state: Barcelona
city: Gavà
country: Spain
facility: Primary Care Center Doctor Bartomeu Fabres Anglada
state: Barcelona
Study officials:
affiliation: Foundation Sant Joan de Deu
name: Antoni Serrano, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Rubio-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.