Phase 4
N=68
Cost- Effectiveness and Quality of Life Assessment in Major Depression Disorder
Depression
Bottom Line
View on ClinicalTrials.gov: NCT02901249 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Number of Participants With Response to Treatment — 58 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- sertraline (Drug); Nortriptyline (Drug); Lithium (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Federal University of Rio Grande do Sul
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Response to Treatment |
58 | — |
| SECONDARY Number of Participants With Remission to Treatment |
32 | — |
| SECONDARY Quality of Life -WHOQOL Intrument Scores |
9.45 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- ages between 18 and 65;
- current acute unipolar depression episode;
- total capacity to understand and respond to self-applied instruments;
- the presence of symptoms in the last 30 days;
- abstinence for at least 30 days for drug addicts
Exclusion Criteria
- presence of Organic Brain Syndrome (OBS);
- pregnancy or lactation;
- criteria for psychiatric hospitalization.
Data sourced from ClinicalTrials.gov (NCT02901249). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.