Cost- Effectiveness and Quality of Life Assessment in Mood Disorder

NCT ID: NCT02870283

Last Updated: 2020-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2015-09-30

Brief Summary

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.

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.

Conditions

Bipolar Disorder

Keywords

Cost effectiveness; Bipolar disorder; Mixed episodes; Quality of life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Lithium

Intervention Type: DRUG

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)

Group Type: ACTIVE_COMPARATOR

Valproic Acid

Intervention Type: DRUG

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)

Group Type: ACTIVE_COMPARATOR

Carbamazepine

Intervention Type: DRUG

Interventions

Lithium

Intervention Type: DRUG

Valproic Acid

Intervention Type: DRUG

Carbamazepine

Intervention Type: DRUG

Other Intervention Names

carbolitium; depakene; tegretol

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

Identifier Type: -

Identifier Source: org_study_id