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

Tracking Information
First Received Date ^ICMJE	April 3, 2012
Last Updated Date	April 4, 2012
Start Date ^ICMJE	March 2010
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 4, 2012)	depression level [ Time Frame: six months ] [ Designated as safety issue: No ] evaluation depression level by Beck scale
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01571973 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 4, 2012)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluation of Pharmaceutical Care in Depressed Outpatients
Official Title ^ICMJE	EVALUATION OF THE EFFECTIVENESS OF PHARMACEUTICAL CARE (DÁDER PROGRAM) IN DEPRESSED OUTPATIENTS TREATED WITH PSYCHOTROPIC
Brief Summary	The study examines whether pharmacotherapeutic follow-up improves outcomes of treatment of depressed outpatients.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Condition ^ICMJE	Depression
Intervention ^ICMJE	Procedure: pharmacotherapeutic follow-up health education adjustment of dose improve compliance replacement of medication
Study Arm (s)	No Intervention: control group outpatients receiving usual care Experimental: intervention group outpatients receiving pharmaceutical care or pharmacotherapeutic follow-up by 6 months Intervention: Procedure: pharmacotherapeutic follow-up
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	60
Estimated Completion Date	May 2012
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01571973
Other Study ID Numbers ^ICMJE	SPPsicobio1Lu
Has Data Monitoring Committee	Yes
Responsible Party	Ana Regina Noto, Federal University of São Paulo
Study Sponsor ^ICMJE	Federal University of São Paulo
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Federal University of São Paulo
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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