Evaluation of Pharmaceutical Care in Depressed Outpatients (depression)

April 4, 2012 updated by: Ana Regina Noto, Federal University of São Paulo

EVALUATION OF THE EFFECTIVENESS OF PHARMACEUTICAL CARE (DÁDER PROGRAM) IN DEPRESSED OUTPATIENTS TREATED WITH PSYCHOTROPIC

The study examines whether pharmacotherapeutic follow-up improves outcomes of treatment of depressed outpatients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women between 18 and 65 years, with diagnostic hypothesis of depression at the beginning of treatment or change in treatment unless 2 months (dosage or substance)

Exclusion Criteria:

  • record of dependence on psychoactive substances, diagnosed schizophrenia,
  • low education (illiterate) or cognitive impairment evident that compromise the completion of research instruments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
outpatients receiving usual care
Experimental: intervention group
outpatients receiving pharmaceutical care or pharmacotherapeutic follow-up by 6 months
Procedure: pharmacotherapeutic follow-up
health education adjustment of dose improve compliance replacement of medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
depression level
Time Frame: six months
evaluation depression level by Beck scale
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anxiety level
Time Frame: 6 months
evaluation anxiety level by Beck scale.
6 months
compliance
Time Frame: 6 months
evaluation antidepressive treatment compliance by Morisky scale
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

April 3, 2012

First Submitted That Met QC Criteria

April 4, 2012

First Posted (Estimate)

April 5, 2012

Study Record Updates

Last Update Posted (Estimate)

April 5, 2012

Last Update Submitted That Met QC Criteria

April 4, 2012

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPPsicobio1Lu

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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