Phase 4
Completed N=78
Cost- Effectiveness and Quality of Life Assessment in Bipolar Disorder Depressive Episode
Source: ClinicalTrials.gov NCT02918097 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Number of Participants With Response to Treatment" — 65 Participants
Summary
To evaluate the effectiveness of an algorithm for Bipolar Disorder depressive episodes (BDD) using medications available in the Brazilian Public Healthcare System (SUS). Quality of life assessment of these patients was also employed.
A randomized pragmatic trial was conducted. An algorithm was developed for the treatment of episodes of bipolar disorder depression episodes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Response to Treatment" |
65 | — |
| PRIMARY Quality of Life Instrument Scores |
10.58 | — |
| SECONDARY Number of Participants With Remission to Treatment |
21 | — |
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 (NCT02918097). 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.