NCT01571973

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable depression

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2012

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

April 5, 2012

Status Verified

June 1, 2011

Enrollment Period

2 years

First QC Date

April 3, 2012

Last Update Submit

April 4, 2012

Conditions

Depression

Keywords

pharmaceutical caredepressioncompliancepharmacist's interventionDáder

Outcome Measures

Primary Outcomes (1)

  • depression level

    evaluation depression level by Beck scale

    six months

Secondary Outcomes (2)

  • anxiety level

    6 months

  • compliance

    6 months

Study Arms (2)

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

pharmacotherapeutic follow-upPROCEDURE

health education adjustment of dose improve compliance replacement of medication

intervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • record of dependence on psychoactive substances, diagnosed schizophrenia,
  • low education (illiterate) or cognitive impairment evident that compromise the completion of research instruments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DepressionPatient Compliance

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

April 3, 2012

First Posted

April 5, 2012

Study Start

March 1, 2010

Primary Completion

March 1, 2012

Study Completion

May 1, 2012

Last Updated

April 5, 2012

Record last verified: 2011-06