Depression Clinical Trial
Official title:
Assessment of Cost- Effectiveness Interventions and the Quality of Life in Patients With Major Depression Through Resources Available in Brazilian Public Health
NCT number | NCT02901249 |
Other study ID # | 017/2009 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 2010 |
Est. completion date | September 2015 |
Verified date | August 2016 |
Source | Federal University of Rio Grande do Sul |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the effectiveness of one algorithm for Major Depression Disorder (MDD) using
medications available in the Brazilian Public Healthcare System (SUS), and assessment of the
quality of life of these patients.
A randomized pragmatic trial was conducted. An algorithm was developed for the treatment of
episodes of unipolar depression episodes.
Status | Completed |
Enrollment | 68 |
Est. completion date | September 2015 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. ages between 18 and 65; 2. current acute unipolar depression episode; 3. total capacity to understand and respond to self-applied instruments; 4. the presence of symptoms in the last 30 days; 5. abstinence for at least 30 days for drug addicts Exclusion Criteria: 1. presence of Organic Brain Syndrome (OBS); 2. pregnancy or lactation; 3. criteria for psychiatric hospitalization. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Federal University of Rio Grande do Sul |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Response to Treatment | Response to treatment was defined as a 50% reduction from baseline scores in Hamilton Rating Scale for Depression (HRSD). The HRSD is abbreviated version, consists of 17 items. The cutoff points are: 7-17 for mild depression,18-24 for moderate depression, and 25 or more for severe depression . | 8 weeks | |
Secondary | Number of Participants With Remission to Treatment | The remission outcome was established as obtaining three consecutive scores of values considered asymptomatic in the Hamilton Rating Scale for Depression (HRSD <7 points) . The subjects that were asymptomatic for at least 6-8 month were considered to be in remission, according to the criteria for partial and complete remission in the DSM-IV. | 8 months | |
Secondary | Quality of Life -WHOQOL Intrument Scores | QOL scores as measured by World Heath Organization Quality of Life - WHOQOL -BREF instrument. scores 0-20 . Higher scores means a better outcome. The measure presented is a overall domain with the mean (SD) |
12 weeks |
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