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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lithium | Active Comparator | 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.
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|
| Acid Valproic | Active Comparator | 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.
|
|
| Carbamazepine | Active Comparator | 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.
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lithium | Drug |
|
| |
| Valproic Acid |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Response to Treatment" | Response to treatment was defined as a 50% reduction from baseline scores in Hamilton Rating Scale for Depression (HRSD)and Young Mania Rating Scale (YMRS) scales HRSD was developed to evaluate and quantify depression.Its abbreviated version,. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal. The cutoff points are: 8-17 for mild depression,18-24 for moderate depression, and 25 or more for severe depression. The maximum score being 52 on the 17-point scale. YMRS is is the most widely used assessment tool for manic symptoms. The scale consists of 11 items .The YMRS follows the style of the Hamilton Rating Scale for Depression (HAM-D) with each item given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/agressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Scores of YMRS > 20 generates indicate mania | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Remission to Treatment | The remission outcome was established as obtaining three consecutive visits with scores of values considered asymptomatic Hamilton Rating Scale for Depression(HRSD <7 points) and Young Mania Rating Scale (YMRS <6 points) during the trial. The subjects that were asymptomatic for at least 6-8 month were considered to be in partial remission and complete if at least 12 months without symptoms, according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcelo Fleck, PhD | Federal University of Rio Grande do Sul | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28832750 | Derived | 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. |
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Response to treatment was assessed for the entire algorithm. There were no comparisons between the steps of each arm of the study
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| ID | Title | Description |
|---|---|---|
| FG000 | 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.
Lithium |
| FG001 | 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.
Valproic Acid |
| FG002 | 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.
Carbamazepine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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.
Lithium |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Response to Treatment" | Response to treatment was defined as a 50% reduction from baseline scores in Hamilton Rating Scale for Depression (HRSD)and Young Mania Rating Scale (YMRS) scales HRSD was developed to evaluate and quantify depression.Its abbreviated version,. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal. The cutoff points are: 8-17 for mild depression,18-24 for moderate depression, and 25 or more for severe depression. The maximum score being 52 on the 17-point scale. YMRS is is the most widely used assessment tool for manic symptoms. The scale consists of 11 items .The YMRS follows the style of the Hamilton Rating Scale for Depression (HAM-D) with each item given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/agressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Scores of YMRS > 20 generates indicate mania | Posted | Count of Participants | Participants | 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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.
Lithium |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dra. Ana Flávia Silva Lima | Universidade Federal do Rio Grande do Sul | +5551999185180 | afbslima@gmail.com |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008094 | Lithium |
| D014635 | Valproic Acid |
| D002220 | Carbamazepine |
| ID | Term |
|---|---|
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
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|
| Drug |
|
|
| Carbamazepine | Drug |
|
|
| 8 months |
| Quality of Life - WHOQOL Bref Intrument | Quality of Life - WHOQOL -BREF instrument scores scores 0-20 . higher scores mean a better outcome. The quality of life was assessed for entire algorithm. There were no comparisons between each arms of the study. | 12 weeks |
| BG001 | 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.
Valproic Acid |
| BG002 | 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.
Carbamazepine |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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.
Lithium |
| OG001 | 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.
Valproic Acid |
| OG002 | 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.
Carbamazepine |
|
|
| Secondary | Number of Participants With Remission to Treatment | The remission outcome was established as obtaining three consecutive visits with scores of values considered asymptomatic Hamilton Rating Scale for Depression(HRSD <7 points) and Young Mania Rating Scale (YMRS <6 points) during the trial. The subjects that were asymptomatic for at least 6-8 month were considered to be in partial remission and complete if at least 12 months without symptoms, according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). | Posted | Count of Participants | Participants | 8 months |
|
|
|
| Secondary | Quality of Life - WHOQOL Bref Intrument | Quality of Life - WHOQOL -BREF instrument scores scores 0-20 . higher scores mean a better outcome. The quality of life was assessed for entire algorithm. There were no comparisons between each arms of the study. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | 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.
Valproic Acid | 0 | 35 | 0 | 35 | 0 | 35 |
| EG002 | 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.
Carbamazepine | 0 | 34 | 0 | 34 | 0 | 34 |
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| D008670 |
| Metals |
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |