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
|
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
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
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.