Cost- Effectiveness and Quality of Life Assessment in Major Depression Disorder

Federal University of Rio Grande do Sul

Status and phase: Completed; Phase 4

Conditions: Depression

Treatments: Drug: Nortriptyline; Drug: Lithium; Drug: sertraline

Study type: Interventional

Funder types: Other

Identifiers

NCT02901249

017/2009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ages between 18 and 65;
2. current acute unipolar depression episode;
3. total capacity to understand and respond to self-applied instruments;
4. the presence of symptoms in the last 30 days;
5. abstinence for at least 30 days for drug addicts

Exclusion criteria

1. presence of Organic Brain Syndrome (OBS);
2. pregnancy or lactation;
3. criteria for psychiatric hospitalization.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

---

68 participants in 1 patient group

Sertraline

Experimental group

Description:

Group Started: sertraline (50mg-200mg) Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks. First step: Monotherapy with sertraline (50-200mg). Non responsive patients: 2nd step. Second step: Sertraline 200mg + lithium (900mg-1500mg) Non responsive patients: 3rd step. Third step: Nortriptyline 100mg Non responsive patients: 4th step. Fourth step: Nortriptyline 100mg + lithium (900mg-1500mg) Non responsive patients : 5th step Fifth step : Nortriptyline 100mg + sertraline 200mg Non responsive patients sixth step: Nortriptyline 100mg + sertraline 200mg + Lithium ( 900mg- 1500mg)

Treatment:

Drug: sertraline

Drug: Lithium

Drug: Nortriptyline