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Evaluation of Pharmaceutical Care in Depressed Outpatients (depression)

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ClinicalTrials.gov Identifier: NCT01571973
Recruitment Status : Unknown
Verified June 2011 by Ana Regina Noto, Federal University of São Paulo.
Recruitment status was:  Active, not recruiting
First Posted : April 5, 2012
Last Update Posted : April 5, 2012
Sponsor:
Information provided by (Responsible Party):
Ana Regina Noto, Federal University of São Paulo

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

Condition or disease Intervention/treatment Phase
Depression Procedure: pharmacotherapeutic follow-up Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : March 2010
Actual Primary Completion Date : March 2012
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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


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

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



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

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 Posted: April 5, 2012    Key Record Dates
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