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Evaluation of Pharmaceutical Care in Depressed Outpatients (depression)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Ana Regina Noto, Federal University of São Paulo.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01571973
First Posted: April 5, 2012
Last Update Posted: April 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ana Regina Noto, Federal University of São Paulo
  Purpose
The study examines whether pharmacotherapeutic follow-up improves outcomes of treatment of depressed outpatients.

Condition Intervention
Depression Procedure: pharmacotherapeutic follow-up

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: EVALUATION OF THE EFFECTIVENESS OF PHARMACEUTICAL CARE (DÁDER PROGRAM) IN DEPRESSED OUTPATIENTS TREATED WITH PSYCHOTROPIC

Further study details as provided by Ana Regina Noto, Federal University of São Paulo:

Primary Outcome Measures:
  • depression level [ Time Frame: six months ]
    evaluation depression level by Beck scale


Secondary Outcome Measures:
  • anxiety level [ Time Frame: 6 months ]
    evaluation anxiety level by Beck scale.

  • compliance [ Time Frame: 6 months ]
    evaluation antidepressive treatment compliance by Morisky scale


Estimated Enrollment: 60
Study Start Date: March 2010
Estimated Study Completion Date: May 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Ana Regina Noto, Ph.D., Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01571973     History of Changes
Other Study ID Numbers: SPPsicobio1Lu
First Submitted: April 3, 2012
First Posted: April 5, 2012
Last Update Posted: April 5, 2012
Last Verified: June 2011

Keywords provided by Ana Regina Noto, Federal University of São Paulo:
pharmaceutical care
depression
compliance
pharmacist's intervention
Dáder

Additional relevant MeSH terms:
Depression
Behavioral Symptoms