Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care (PRODEFAR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Fundació Sant Joan de Déu.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Carlos III Health Institute
Catalan Institute of Health
University of Barcelona
Information provided by:
Fundació Sant Joan de Déu
ClinicalTrials.gov Identifier:
NCT00794196
First received: November 17, 2008
Last updated: July 22, 2011
Last verified: July 2011
  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
Behavioral: Pharmaceutical care program for antidepressant treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Impact of the Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care on the Compliance to Antidepressants and Patient Wellbeing

Resource links provided by NLM:


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: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
The control group will be receiving usual medical and pharmaceutical care.
Experimental: Intervention Group
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.
Other Name: PRODEFAR group

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00794196

Locations
Spain
Primary Care Center Gavà 1
Gava, Barcelona, Spain, 08850
Primary Care Center Doctor Bartomeu Fabres Anglada
Gavà, Barcelona, Spain, 08850
Sponsors and Collaborators
Fundació Sant Joan de Déu
Carlos III Health Institute
Catalan Institute of Health
University of Barcelona
Investigators
Principal Investigator: Antoni Serrano, MD PhD Foundation Sant Joan de Deu
  More Information

No publications provided by Fundació Sant Joan de Déu

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D., Ph.D., Antoni Serrano Blanco, Foundation Sant Joan de Deu
ClinicalTrials.gov Identifier: NCT00794196     History of Changes
Other Study ID Numbers: FIS PI070546
Study First Received: November 17, 2008
Last Updated: July 22, 2011
Health Authority: Spain: Ministry of Health and Consumption

Keywords provided by Fundació Sant Joan de Déu:
Medication adherence
Antidepressive agents
Primary care
Pharmaceutical care

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014