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Trial record 61 of 83 for:    CARBAMAZEPINE AND Cytochrome P-450 CYP3A Inducers

Cost- Effectiveness and Quality of Life Assessment in Mood Disorder

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ClinicalTrials.gov Identifier: NCT02870283
Recruitment Status : Completed
First Posted : August 17, 2016
Last Update Posted : August 17, 2016
Sponsor:
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 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.


Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Lithium Drug: Valproic Acid Drug: Carbamazepine 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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Cost- Effectiveness Interventions and the Quality of Life in Patients With Mood Disorders Through Resources Available in Brazilian Public Health
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


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 Name: 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 Name: 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 Name: tegretol




Primary Outcome Measures :
  1. Response to treatment [ Time Frame: 8 weeks ]
    The main outcomes were response to treatment and remission of symptoms. 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
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.

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 ClinicalTrials.gov identifier (NCT number): NCT02870283


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ana Flávia Barros da Silva Lima, Principal Investigator, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT02870283     History of Changes
Other Study ID Numbers: 09-013
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 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
Mixed episodes
Quality of life
Additional relevant MeSH terms:
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Carbamazepine
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Disease
Bipolar Disorder
Mood Disorders
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Valproic Acid
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anticonvulsants
GABA Agents
Neurotransmitter Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Sodium Channel Blockers
Membrane Transport Modulators