Cost- Effectiveness and Quality of Life Assessment in Bipolar Disorder Depressive Episode
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|ClinicalTrials.gov Identifier: NCT02918097|
Recruitment Status : Completed
First Posted : September 28, 2016
Last Update Posted : September 28, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Drug: Lithium Carbonate Drug: Sertraline Drug: Nortriptyline Drug: Risperidone||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cost- Effectiveness and Quality of Life Assessment in Bipolar Disorder Depressive Episode|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||September 2015|
Group 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.
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).
Drug: Lithium Carbonate
Other Name: Carbolitium
Other Name: Zoloft
Other Name: Pamelor
Other Name: Risperdal
- Response to treatment [ Time Frame: 8 weeks ]Response to treatment was defined as a 50% reduction from baseline in HRSD and YMRS scales.
- Remission [ Time Frame: 8 months ]The remission outcome was established as obtaining three consecutive scores of values considered asymptomatic (HRSD <7 points, and YMRS <6 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.
- Quality of life [ Time Frame: 12 weeks ]QOL scores as measured by World Heath Organization Quality of Life - WHOQOL -BREF instrument.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918097
|Principal Investigator:||Marcelo Fleck, PhD||Federal University of Rio Grande do Sul|