Bipolar Disorder
Conditions
Keywords
Cost effectiveness, Bipolar disorder, Depressive episodes, Quality of Life
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.
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.
Interventions
DRUGLithium Carbonate
DRUGSertraline
DRUGNortriptyline
DRUGRisperidone
Sponsors
Federal University of Rio Grande do Sul
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a pragmatical clinical trial. The patients follow a pre-established algorithm About the participant flow the results the table to indicate the number of participants who received treatment in the whole algoritm, not in each step.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Response to Treatment | 8 weeks | 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 |
| Quality of Life Instrument Scores | 12 weeks | Quality of Life - WHOQOL -BREF instrument scores scores 0-20 . higher scores mean a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Remission to Treatment | 8 months | 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). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lithium Carbonate Group Started: Lithium Carbonate (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).
Lithium Carbonate
Sertraline
Nortriptyline
Risperidone | 78 |
| Total | 78 |
Baseline characteristics
| Characteristic | Lithium Carbonate |
|---|---|
| Age, Continuous | 40.4 years STANDARD_DEVIATION 11.4 |
| Region of Enrollment Brazil | 78 participants |
| Sex: Female, Male Female | 61 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 78 |
| other Total, other adverse events | 0 / 78 |
| serious Total, serious adverse events | 0 / 78 |
Outcome results
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
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lithium Carbonate | Number of Participants With Response to Treatment | 65 Participants |
Primary
Quality of Life Instrument Scores
Quality of Life - WHOQOL -BREF instrument scores scores 0-20 . higher scores mean a better outcome.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lithium Carbonate | Quality of Life Instrument Scores | 10.58 score on a scale | Standard Deviation 3.64 |
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).
Time frame: 8 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lithium Carbonate | Number of Participants With Remission to Treatment | 21 Participants |