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

NCT ID: NCT02918097

Last Updated: 2020-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2015-09-30

Brief Summary

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.

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 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:

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.

Conditions

Bipolar Disorder

Keywords

Cost effectiveness; Bipolar disorder; Depressive episodes; Quality of Life

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lithium Carbonate

Group Started: Lithium Carbonate (900mg-1500mg)

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 Lithium (LSL 0.6-0.8). Non responsive patients: 2nd step.

Second step: Monotherapy with lithium (LSL 1.0-1.2). Non responsive patients: 3rd step.

Third step: Lithium + Sertraline (50mg-200mg). Non responsive patients: 4th step.

Fourth step: Lithium + Nortriptyline 100mg. Non responsive patients: 5th step.

Fifth step: Lithium + Nortriptyline 100mg + Sertraline (100mg-200mg). Non responsive patients: 6th step

Sixth step: Lithium + Nortriptyline 100mg + Sertraline 200mg + Risperidone (1mg-6mg).

Group Type: EXPERIMENTAL

Lithium Carbonate

Intervention Type: DRUG

Sertraline

Intervention Type: DRUG

Nortriptyline

Intervention Type: DRUG

Risperidone

Intervention Type: DRUG

Interventions

Lithium Carbonate

Intervention Type: DRUG

Sertraline

Intervention Type: DRUG

Nortriptyline

Intervention Type: DRUG

Risperidone

Intervention Type: DRUG

Other Intervention Names

Carbolitium; Zoloft; Pamelor; Risperdal

Eligibility Criteria

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. -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Rio Grande do Sul

OTHER

Sponsor Role: lead

Responsible Party

Ana Flávia Barros da Silva Lima

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcelo Fleck, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

References

Lima AF, Miguel SR, Cohen M, Zimmermann JJ, Shansis FM, Cruz LN, Ziegelmann PK, Polanczyk CA, Fleck MP. Effectiveness evaluation of mood disorder treatment algorithms in Brazilian public healthcare patients. Braz J Psychiatry. 2018 Jan-Mar;40(1):26-34. doi: 10.1590/1516-4446-2016-2147. Epub 2017 Aug 21.

Reference Type: DERIVED

PMID: 28832750 (View on PubMed)

Other Identifiers

09-013/2

Identifier Type: -

Identifier Source: org_study_id