Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Pharmaceutical care program for antidepressant treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>The control group will be receiving usual medical and pharmaceutical care. | |
| Experimental: Intervention Group<br>Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program. | Behavioral: Pharmaceutical care program for antidepressant treatment<br>* The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment.<br>* Other names: PRODEFAR group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to Antidepressant Medication | Adherence to antidepressant medication was measured through Pharmacy records | At 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0, 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication adherence, Antidepressive agents, Primary care, Pharmaceutical care