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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02918097
Recruitment Status : Completed
First Posted : September 28, 2016
Last Update Posted : September 28, 2016
Information provided by (Responsible Party):
Ana Flávia Barros da Silva Lima, Federal University of Rio Grande do Sul

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Lithium Carbonate Drug: Sertraline Drug: Nortriptyline Drug: Risperidone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: Lithium

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

Drug: Sertraline
Other Name: Zoloft

Drug: Nortriptyline
Other Name: Pamelor

Drug: Risperidone
Other Name: Risperdal

Primary Outcome Measures :
  1. Response to treatment [ Time Frame: 8 weeks ]
    Response to treatment was defined as a 50% reduction from baseline in HRSD and YMRS scales.

Secondary Outcome Measures :
  1. 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.

  2. Quality of life [ Time Frame: 12 weeks ]
    QOL scores as measured by World Heath Organization Quality of Life - WHOQOL -BREF instrument.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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. -

Information from the National Library of Medicine

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 identifier (NCT number): NCT02918097

Sponsors and Collaborators
Federal University of Rio Grande do Sul
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Principal Investigator: Marcelo Fleck, PhD Federal University of Rio Grande do Sul

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ana Flávia Barros da Silva Lima, Principal Investigator, Federal University of Rio Grande do Sul Identifier: NCT02918097     History of Changes
Other Study ID Numbers: 09-013/2
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ana Flávia Barros da Silva Lima, Federal University of Rio Grande do Sul:
Cost effectiveness
Bipolar disorder
Depressive episodes
Quality of Life

Additional relevant MeSH terms:
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Bipolar Disorder
Depressive Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Behavioral Symptoms
Mood Disorders
Lithium Carbonate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antidepressive Agents
Enzyme Inhibitors
Antimanic Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators