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

September 19, 2020 updated by: Ana Flávia Barros da Silva Lima, Federal University of Rio Grande do Sul

Assessment of Cost- Effectiveness Interventions and the Quality of Life in Patients With Major Depression Through Resources Available in Brazilian Public Health

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sertraline

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)
Drug: Nortriptyline
Other Names:
  • Cloridrate of nortrytyline
Drug: sertraline
Other Names:
  • Cloridrate of sertraline
Drug: Lithium
Other Names:
  • Lithium Carbonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Response to Treatment
Time Frame: 8 weeks
Response to treatment was defined as a 50% reduction from baseline scores in Hamilton Rating Scale for Depression (HRSD). The HRSD is abbreviated version, consists of 17 items. The cutoff points are: 7-17 for mild depression,18-24 for moderate depression, and 25 or more for severe depression .
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Remission to Treatment
Time Frame: 8 months
The remission outcome was established as obtaining three consecutive scores of values considered asymptomatic in the Hamilton Rating Scale for Depression (HRSD <7 points) . The subjects that were asymptomatic for at least 6-8 month were considered to be in remission, according to the criteria for partial and complete remission in the DSM-IV.
8 months
Quality of Life -WHOQOL Intrument Scores
Time Frame: 12 weeks

QOL scores as measured by World Heath Organization Quality of Life - WHOQOL -BREF instrument.

scores 0-20 . Higher scores means a better outcome. The measure presented is a overall domain with the mean (SD)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Rio Grande do Sul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

September 11, 2016

First Submitted That Met QC Criteria

September 11, 2016

First Posted (Estimate)

September 15, 2016

Study Record Updates

Last Update Posted (Actual)

October 14, 2020

Last Update Submitted That Met QC Criteria

September 19, 2020

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 017/2009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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