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Completed

NCT Number: NCT02918097

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

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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:

  • Sample selection by being referred from the primary healthcare clinics in the municipality;
  • Informative talk about mood disorders and the research, with the informed consent forms being provided to the subjects;
  • Screening for unipolar depression episodes with the use of the Patient Health Questionnaire (PHQ-9), and Hypomanic Symptoms Checklist Brazilian Version (HCL -32-BV);
  • Diagnostic evaluation through the Mini International Neuropsychiatric Interview (MINI) and clinical interview for individuals with positive results in the screening instruments;
  • Baseline and demographic assessments using standardized semi-structured interviews in the first and second visits;
  • 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);
  • Biweekly follow-up, changed to monthly after stabilization - with a maximum follow-up period of 52 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ages between 18 and 65;
  • BD current acute mixed episode;
  • total capacity to understand and respond to self-applied instruments;
  • the presence of symptoms in the last 30 days;
  • abstinence for at least 30 days for drug addicts.

Exclusion criteria

  • presence of Organic Brain Syndrome (OBS);
  • pregnancy or lactation;
  • criteria for psychiatric hospitalization. -

Treatment and study plan

Lithium Carbonate

Drug

Other names: Carbolitium

Sertraline

Drug

Other names: Zoloft

Nortriptyline

Drug

Other names: Pamelor

Risperidone

Drug

Other names: Risperdal

Primary outcomes

  1. 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)and Young Mania Rating Scale (YMRS) scales HRSD was developed to evaluate and quantify depression.Its abbreviated version,. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal. The cutoff points are: 8-17 for mild depression,18-24 for moderate depression, and 25 or more for severe depression. The maximum score being 52 on the 17-point scale.

    YMRS is is the most widely used assessment tool for manic symptoms. The scale consists of 11 items .The YMRS follows the style of the Hamilton Rating Scale for Depression (HAM-D) with each item given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/agressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Scores of YMRS > 20 generates indicate mania

  2. Quality of Life Instrument Scores

    Time frame: 12 weeks

    Quality of Life - WHOQOL -BREF instrument scores

    scores 0-20 . higher scores mean a better outcome.

Secondary outcomes

  1. Number of Participants With Remission to Treatment

    Time frame: 8 months

    The remission outcome was established as obtaining three consecutive visits with scores of values considered asymptomatic Hamilton Rating Scale for Depression(HRSD <7 points) and Young Mania Rating Scale (YMRS <6 points) during the trial. The subjects that were asymptomatic for at least 6-8 month were considered to be in partial remission and complete if at least 12 months without symptoms, according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).

Sponsors and collaborators

Lead sponsor

Federal University of Rio Grande do Sul

Other

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Sep 28, 2016
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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