Phase 4
Completed N=107
Cost- Effectiveness and Quality of Life Assessment in Mood Disorder
Source: ClinicalTrials.gov NCT02870283 ↗Enrolled (actual)
107
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Number of Participants With Response to Treatment" — 31; 28; 27 Participants
◆ Published Evidence
Emerging
6citations · ~1 / year
Effectiveness evaluation of mood disorder treatment algorithms in Brazilian public healthcare patients.
Summary
To evaluate the effectiveness of three systematic interventions for Bipolar Disorder (BD) mixed episodes 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 bipolar mixed episodes.
Linked Publications
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Effectiveness evaluation of mood disorder treatment algorithms in Brazilian public healthcare patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Response to Treatment" |
31; 28; 27 | — |
| SECONDARY Number of Participants With Remission to Treatment |
10; 9; 9 | — |
| SECONDARY Quality of Life - WHOQOL Bref Intrument |
10.91; 10.91; 10.91 | — |
Eligibility Criteria
Inclusion Criteria
- ages between 18 and 65;
- BD current acute mixed 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 (NCT02870283) and the linked publication. 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. Informational only — not medical advice.