NCT00794196

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 19, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

August 15, 2016

Completed
Last Updated

November 22, 2016

Status Verified

October 1, 2016

Enrollment Period

3.1 years

First QC Date

November 17, 2008

Results QC Date

April 13, 2016

Last Update Submit

October 1, 2016

Conditions

Depression

Keywords

Medication adherenceAntidepressive agentsPrimary carePharmaceutical care

Outcome Measures

Primary Outcomes (1)

  • Adherence to Antidepressant Medication

    Adherence to antidepressant medication was measured through Pharmacy records

    At 3 and 6 months

Secondary Outcomes (1)

  • Patient Wellbeing

    0, 3 and 6 months

Study Arms (2)

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

Interventions

Pharmaceutical care program for antidepressant treatmentBEHAVIORAL

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

Also known as: PRODEFAR group
Intervention Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis for depression from a general practitioner
  • Beginning a pharmacological antidepressant treatment
  • Going to one of the participant community pharmacies

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Primary Care Center Doctor Bartomeu Fabres Anglada

Gavà, Barcelona, 08850, Spain

Location

Primary Care Center Gavà 1

Gavà, Barcelona, 08850, Spain

Location

Related Publications (2)

  • 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.

    PMID: 23950967DERIVED

  • 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.

    PMID: 19656386DERIVED

MeSH Terms

Conditions

DepressionMedication Adherence

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Results Point of Contact

Title
Dr. Antoni Serrano Blanco
Organization
Parc Sanitari Sant Joan de Déu
aserrano@pssjd.org
+34936406350

Study Officials

  • Antoni Serrano, MD PhD

    Foundation Sant Joan de Deu

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Antoni Serrano Blanco

Study Record Dates

First Submitted

November 17, 2008

First Posted

November 19, 2008

Study Start

October 1, 2008

Primary Completion

November 1, 2011

Study Completion

November 1, 2012

Last Updated

November 22, 2016

Results First Posted

August 15, 2016

Record last verified: 2016-10

Locations

ES(2)