Cost- Effectiveness and Quality of Life Assessment in Bipolar Disorder Depressive Episode
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Lithium Carbonate; Sertraline; Nortriptyline; Risperidone
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Carbolitium; Zoloft; Pamelor; Risperdal
Intervention MeSH terms: Risperidone; Lithium Carbonate; Sertraline; Nortriptyline
Intervention model: Sequential Assignment
Intervention model description: This is a pragmatical clinical trial. The patients follow a pre-established algorithm About the participant flow the results the table to indicate the number of participants who received treatment in the whole algoritm, not in each step.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cost effectiveness; Bipolar disorder; Depressive episodes; Quality of Life