Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care

Depression Clinical Trial

— PRODEFAR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00794196
• Other study ID #: FIS PI070546
• Status: Active, not recruiting
• Phase: N/A
• First received: November 17, 2008
• Last updated: July 22, 2011
• Start date: October 2008
• Est. completion date: October 2011

Study information

• Verified date: July 2011
• Source: Fundació Sant Joan de Déu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Pharmaceutical care program for antidepressant treatment
The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment.

Locations

Country	Name	City	State
Spain	Primary Care Center Gavà 1	Gava	Barcelona
Spain	Primary Care Center Doctor Bartomeu Fabres Anglada	Gavà	Barcelona

Sponsors (4)

Lead Sponsor	Collaborator
Fundació Sant Joan de Déu	Carlos III Health Institute, Catalan Institute of Health, University of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to antidepressant medication		At 3 and 6 months	No
Secondary	Patient wellbeing		0, 3 and 6 months	No