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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01571973
Other study ID # SPPsicobio1Lu
Secondary ID
Status Active, not recruiting
Phase N/A
First received April 3, 2012
Last updated April 4, 2012
Start date March 2010
Est. completion date May 2012

Study information

Verified date June 2011
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date May 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Procedure:
pharmacotherapeutic follow-up
health education adjustment of dose improve compliance replacement of medication

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Federal University of São Paulo

Outcome

Type Measure Description Time frame Safety issue
Primary depression level evaluation depression level by Beck scale six months No
Secondary anxiety level evaluation anxiety level by Beck scale. 6 months No
Secondary compliance evaluation antidepressive treatment compliance by Morisky scale 6 months No
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