Evaluation of Pharmaceutical Care in Depressed Outpatients | NCT01571973

Studies
Evaluation of Pharmaceutical Care in Depressed Outpatients

NCT01571973

Sponsor

Federal University of São Paulo

Status

Unknown status

Last Update Posted

Apr 5, 2012Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Depression

Interventions

pharmacotherapeutic follow-up

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Mar 2012Actual

Completion Date

May 2012Estimated

First Submitted Date

Apr 3, 2012

First Submission Date that Met QC Criteria

Apr 4, 2012

First Posted Date

Apr 5, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2012

Last Update Posted Date

Apr 5, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control group	No Intervention	outpatients receiving usual care
intervention group	Experimental	outpatients receiving pharmaceutical care or pharmacotherapeutic follow-up by 6 months	Procedure: pharmacotherapeutic follow-up

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pharmacotherapeutic follow-up	Procedure	health education adjustment of dose improve compliance replacement of medication	intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
depression level	evaluation depression level by Beck scale	six months

Secondary Outcomes

Measure	Description	Time Frame
anxiety level	evaluation anxiety level by Beck scale.	6 months
compliance	evaluation antidepressive treatment compliance by Morisky scale

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Type	Date	Date Unknown
Release	Feb 13, 2019
Reset	May 10, 2019
Release	Feb 17, 2020
Reset	Feb 27, 2020

Submission Tracking

Estimated Results First Submitted Date

Feb 13, 2019

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 13, 2019			May 10, 2019
Feb 17, 2020

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D010349	Patient Compliance

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D010342	Patient Acceptance of Health Care
D000074822	Treatment Adherence and Compliance

Browse Leaves

Not provided

Browse Branches

Not provided