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Completed

NCT Number: NCT00794196

Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Primary Care Center Doctor Bartomeu Fabres Anglada, Gavà, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmaceutical care program for antidepressant treatment

Behavioral

The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment.

Other names: PRODEFAR group

Primary outcomes

  1. Adherence to Antidepressant Medication

    Time frame: At 3 and 6 months

    Adherence to antidepressant medication was measured through Pharmacy records

Secondary outcomes

  1. Patient Wellbeing

    Time frame: 0, 3 and 6 months

    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.

Sponsors and collaborators

Lead sponsor

Fundació Sant Joan de Déu

Other

Collaborators

  • Carlos III Health Institute
  • Catalan Institute of Health
  • University of Barcelona

Registry information

Official study title

Impact of the Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care on the Compliance to Antidepressants and Patient Wellbeing

Acronym: PRODEFAR

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Nov 19, 2008
Registry last updated
Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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