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Evaluation of Pharmaceutical Care in Depressed Outpatients (depression)

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pharmacotherapeutic follow-up
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression focused on measuring pharmaceutical care, depression, compliance, pharmacist's intervention, Dáder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    control group

    intervention group

    Arm Description

    outpatients receiving usual care

    outpatients receiving pharmaceutical care or pharmacotherapeutic follow-up by 6 months

    Outcomes

    Primary Outcome Measures

    depression level
    evaluation depression level by Beck scale

    Secondary Outcome Measures

    anxiety level
    evaluation anxiety level by Beck scale.
    compliance
    evaluation antidepressive treatment compliance by Morisky scale

    Full Information

    First Posted
    April 3, 2012
    Last Updated
    April 4, 2012
    Sponsor
    Federal University of São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01571973
    Brief Title
    Evaluation of Pharmaceutical Care in Depressed Outpatients
    Acronym
    depression
    Official Title
    EVALUATION OF THE EFFECTIVENESS OF PHARMACEUTICAL CARE (DÁDER PROGRAM) IN DEPRESSED OUTPATIENTS TREATED WITH PSYCHOTROPIC
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2011
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2010 (undefined)
    Primary Completion Date
    March 2012 (Actual)
    Study Completion Date
    May 2012 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of São Paulo

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression
    Keywords
    pharmaceutical care, depression, compliance, pharmacist's intervention, Dáder

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    outpatients receiving usual care
    Arm Title
    intervention group
    Arm Type
    Experimental
    Arm Description
    outpatients receiving pharmaceutical care or pharmacotherapeutic follow-up by 6 months
    Intervention Type
    Procedure
    Intervention Name(s)
    pharmacotherapeutic follow-up
    Intervention Description
    health education adjustment of dose improve compliance replacement of medication
    Primary Outcome Measure Information:
    Title
    depression level
    Description
    evaluation depression level by Beck scale
    Time Frame
    six months
    Secondary Outcome Measure Information:
    Title
    anxiety level
    Description
    evaluation anxiety level by Beck scale.
    Time Frame
    6 months
    Title
    compliance
    Description
    evaluation antidepressive treatment compliance by Morisky scale
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of Pharmaceutical Care in Depressed Outpatients

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