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Evaluation of Pharmaceutical Care in Depressed Outpatients (depression)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ana Regina Noto, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01571973
First received: April 3, 2012
Last updated: April 4, 2012
Last verified: June 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: EVALUATION OF THE EFFECTIVENESS OF PHARMACEUTICAL CARE (DÁDER PROGRAM) IN DEPRESSED OUTPATIENTS TREATED WITH PSYCHOTROPIC

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Depression
U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • depression level [ Time Frame: six months ] [ Designated as safety issue: No ]
    evaluation depression level by Beck scale


Secondary Outcome Measures:
  • anxiety level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    evaluation anxiety level by Beck scale.

  • compliance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 65 Years
Genders 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

No publications provided

Responsible Party: Ana Regina Noto, Ph.D., Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01571973     History of Changes
Other Study ID Numbers: SPPsicobio1Lu
Study First Received: April 3, 2012
Last Updated: April 4, 2012
Health Authority: Brazil: Ministry of Health

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013