Cost- Effectiveness and Quality of Life Assessment in Major Depression Disorder
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

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.
    

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
      major depression 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): sertraline; Nortriptyline; Lithium
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Cloridrate of sertraline; Cloridrate of nortrytyline; Lithium Carbonate
Intervention MeSH terms: Lithium Carbonate; Sertraline; Nortriptyline
Intervention model: Sequential Assignment
Intervention model description: Patients start treatment according to the algorithm and follow a sequence of steps. There is no comparison between groups. It is a single group. Primary and secondary outcomes are only assessed at the end of the protocol, not at each step.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cost effectiveness; Unipolar Depression; Major Depression Disorder; Quality of life disorder