Evaluation of Pharmaceutical Care in Depressed Outpatients (depression)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Federal University of São Paulo.
Recruitment status was  Active, not recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014