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Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care (PRODEFAR)
This study is currently recruiting participants.
Verified by Fundació Sant Joan de Déu, November 2008
Sponsors and Collaborators: Fundació Sant Joan de Déu
Carlos III Health Institute
Catalan Institute of Health
University of Barcelona (UB)
Information provided by: Fundació Sant Joan de Déu
ClinicalTrials.gov Identifier: NCT00794196
  Purpose

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.


Condition Intervention
Depression
Antidepressive Agents
Primary Care
Behavioral: Pharmaceutical care program for antidepressant treatment

MedlinePlus related topics: Antidepressants Depression
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Double Blind (Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title: Impact of the Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care on the Compliance to Antidepressants and Patient Wellbeing

Further study details as provided by Fundació Sant Joan de Déu:

Primary Outcome Measures:
  • Adherence to antidepressant medication [ Time Frame: At 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient wellbeing [ Time Frame: 0, 3 and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Usual Care: No Intervention
The control group will be receiving usual medical and pharmaceutical care.
Intervention Group: Experimental
Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.
Behavioral: Pharmaceutical care program for antidepressant treatment
The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment.

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00794196

Contacts
Contact: Maria Rubio, Pharmacist 0034 93 640 63 50 ext 2540 mrubio@sjd-ssm.com

Locations
Spain, Barcelona
Primary Care Center Gavà 1 Recruiting
Gava, Barcelona, Spain, 08850
Contact: Eva Alonso, Doctor         eva76@mixmail.com    
Principal Investigator: Eva Alonso, Doctor            
Primary Care Center Doctor Bartomeu Fabres Anglada Recruiting
Gavà, Barcelona, Spain, 08850
Contact: Maite Peñarubia, Doctor         32829mpm@comb.es    
Principal Investigator: Maite Peñarubia, Doctor            
Sub-Investigator: Annabell Torres, Doctor            
Sponsors and Collaborators
Fundació Sant Joan de Déu
Carlos III Health Institute
Catalan Institute of Health
University of Barcelona (UB)
Investigators
Principal Investigator: Antoni Serrano, MD PhD Foundation Sant Joan de Deu
  More Information

Responsible Party: Foundation Sant Joan de Deu ( M.D., Ph.D., Antoni Serrano Blanco )
Study ID Numbers: FIS PI070546
Study First Received: November 17, 2008
Last Updated: November 17, 2008
ClinicalTrials.gov Identifier: NCT00794196  
Health Authority: Spain: Ministry of Health and Consumption

Study placed in the following topic categories:
Depression
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 14, 2009