MedDataX Logo

Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care

NCT ID: NCT00794196

Last Updated: 2016-11-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Medication adherence Antidepressive agents Primary care Pharmaceutical care

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Usual Care

The control group will be receiving usual medical and pharmaceutical care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Group

Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.

Group Type EXPERIMENTAL

Pharmaceutical care program for antidepressant treatment

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pharmaceutical care program for antidepressant treatment

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PRODEFAR group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Carlos III Health Institute

OTHER_GOV

Sponsor Role collaborator

Catalan Institute of Health

OTHER_GOV

Sponsor Role collaborator

University of Barcelona

OTHER

Sponsor Role collaborator

Fundació Sant Joan de Déu

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Antoni Serrano Blanco

Antoni Serrano Blanco

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Antoni Serrano, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Foundation Sant Joan de Deu

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Primary Care Center Doctor Bartomeu Fabres Anglada

Gavà, Barcelona, Spain

Site Status

Primary Care Center Gavà 1

Gavà, Barcelona, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 23950967 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19656386 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FIS PI070546

Identifier Type: -

Identifier Source: org_study_id