Cost- Effectiveness and Quality of Life Assessment in Mood Disorder

October 25, 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 Mood Disorders Through Resources Available in Brazilian Public Health

To evaluate the effectiveness of three systematic interventions for Bipolar Disorder (BD) mixed episodes 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 bipolar mixed 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 mixed 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 BD mixed 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)

107

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. BD current acute mixed 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: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Lithium

Subjects were randomized into three groups: (lithium, valproic acid, or carbamazepine).

Group (A) Started Lithium (900mg-1500mg)

Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.

  1. First step: Monotherapy with Lithium (900-1500mg) Non responsive patients: 2nd step.

  2. Second step: Randomization for lithium (900mg-1500mg) + valproic acid (1000mg-1500mg) OR lithium (900mg-1500mg) + carbamazepine (600mg-1200mg).

    Non responsive patients: 3rd step.

  3. Third step: Crossover lithium (900mg-1500mg) + valproic acid (1000mg-1500mg) X lithium (900mg-1500mg) + carbamazepine (600mg-1200mg).

    Non responsive patients: 4th step.

  4. Fourth step: Association with risperidone (1-6mg)
Drug: Lithium
Other Names:
  • carbolitium
ACTIVE_COMPARATOR: Acid Valproic

Subjects were randomized into three groups: (lithium, valproic acid, or carbamazepine).

Group (B) Started Valproic Acid (1000mg-1500mg).

Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.

  1. First step: Monotherapy with Valproic Acid (1000mg-1500mg) Non responsive patients: 2nd step.
  2. Second step: Association with lithium (900mg-1500mg). Non responsive patients: 3rd step.
  3. Third step: Crossover: lithium (900mg-1500mg) + carbamazepine (600mg-1200mg). Non responsive patients: 4th step.
  4. Fourth step: Association with risperidone (1-6mg)
Drug: Valproic Acid
Other Names:
  • depakene
ACTIVE_COMPARATOR: Carbamazepine

Subjects were randomized into three groups: (lithium, valproic acid, or carbamazepine).

Group (C) Started Carbamazepine (600mg-1200mg).

Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.

  1. First step: Monotherapy with Carbamazepine (600mg-1200mg). Non responsive patients: 2nd step.
  2. Second step: Association with lithium (900mg-1500mg). Non responsive patients: 3rd step.
  3. Third step: Crossover: lithium (900mg-1500mg) + valproic acid (1000mg-1500mg). Non responsive patients: 4th step.
  4. Fourth step: Association with risperidone (1-6mg)
Drug: Carbamazepine
Other Names:
  • tegretol

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)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
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 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).
8 months
Quality of Life - WHOQOL Bref Intrument
Time Frame: 12 weeks
Quality of Life - WHOQOL -BREF instrument scores scores 0-20 . higher scores mean a better outcome. The quality of life was assessed for entire algorithm. There were no comparisons between each arms of the study.
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

May 26, 2016

First Submitted That Met QC Criteria

August 12, 2016

First Posted (ESTIMATE)

August 17, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 20, 2020

Last Update Submitted That Met QC Criteria

October 25, 2020

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-013

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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