NCT02918097

Cost- Effectiveness and Quality of Life Assessment in Bipolar Disorder Depressive Episode

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Federal University of Rio Grande do Sul · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study design was that of a pragmatic randomized clinical trial to evaluate the effectiveness of treatments for mood disorders in a public healthcare context in the city of Porto Alegre, in southern Brazil. The algorithm was originally developed for the treatment of bipolar disorder depressive episodes by a Delphi panel of experts from psychiatric associations in Brazil. All subjects provided an informed consent form, in writing, in order to participate in the study protocol, which was approved by the institutional ethics committee. Procedures and measurements of the study: The subjects under evaluation were selected and they followed the stages defined by the treatment protocol: 1. Sample selection by being referred from the primary healthcare clinics in the municipality; 2. Informative talk about mood disorders and the research, with the informed consent forms being provided to the subjects; 3. Screening for unipolar depression episodes with the use of the Patient Health Questionnaire (PHQ-9), and Hypomanic Symptoms Checklist Brazilian Version (HCL -32-BV); 4. Diagnostic evaluation through the Mini International Neuropsychiatric Interview (MINI) and clinical interview for individuals with positive results in the screening instruments; 5. Baseline and demographic assessments using standardized semi-structured interviews in the first and second visits; 6. In each clinic visit, the severity of the symptoms were evealuated using the Clinical Global Impression Scale (CGI), Hamilton Rating Scale for Depression (HRSD), and Young Manic Rating Scale (YMRS); 7. Biweekly follow-up, changed to monthly after stabilization - with a maximum follow-up period of 52 weeks.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Lithium Carbonate
DRUG	Sertraline
DRUG	Nortriptyline
DRUG	Risperidone

Timeline

• Start date: 2010-05-01
• Primary completion: 2014-11-01
• Completion: 2015-09-01
• First posted: 2016-09-28
• Last updated: 2020-11-20
• Results posted: 2020-10-14