Depression
Conditions
Keywords
Cost effectiveness, Unipolar Depression, Major Depression Disorder, Quality of life disorder
Brief summary
To evaluate the effectiveness of one algorithm for Major Depression Disorder (MDD) 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 unipolar 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 major depression 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
DRUGsertraline
DRUGNortriptyline
DRUGLithium
Sponsors
Federal University of Rio Grande do Sul
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients start treatment according to the algorithm and follow a sequence of steps. There is no comparison between groups. It is a single group. Primary and secondary outcomes are only assessed at the end of the protocol, not at each step.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. ages between 18 and 65; 2. current acute unipolar depression 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). The HRSD is abbreviated version, consists of 17 items. The cutoff points are: 7-17 for mild depression,18-24 for moderate depression, and 25 or more for severe depression . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Remission to Treatment | 8 months | The remission outcome was established as obtaining three consecutive scores of values considered asymptomatic in the Hamilton Rating Scale for Depression (HRSD \<7 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 -WHOQOL Intrument Scores | 12 weeks | QOL scores as measured by World Heath Organization Quality of Life - WHOQOL -BREF instrument. scores 0-20 . Higher scores means a better outcome. The measure presented is a overall domain with the mean (SD) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sertraline Group Started: sertraline (50mg-200mg)
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 sertraline (50-200mg). Non responsive patients: 2nd step.
Second step: Sertraline 200mg + lithium (900mg-1500mg)
Non responsive patients: 3rd step.
Third step: Nortriptyline 100mg
Non responsive patients: 4th step.
Fourth step: Nortriptyline 100mg + lithium (900mg-1500mg)
Non responsive patients : 5th step
Fifth step : Nortriptyline 100mg + sertraline 200mg Non responsive patients
sixth step: Nortriptyline 100mg + sertraline 200mg + Lithium ( 900mg- 1500mg)
sertraline
Nortriptyline
Lithium | 68 |
| Total | 68 |
Baseline characteristics
| Characteristic | Sertraline |
|---|---|
| Age, Continuous | 40.4 years STANDARD_DEVIATION 11.4 |
| Region of Enrollment Brazil | 68 participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 68 |
| serious Total, serious adverse events | 0 / 68 |
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). The HRSD is abbreviated version, consists of 17 items. The cutoff points are: 7-17 for mild depression,18-24 for moderate depression, and 25 or more for severe depression .
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sertraline | Number of Participants With Response to Treatment | 58 Participants |
Secondary
Number of Participants With Remission to Treatment
The remission outcome was established as obtaining three consecutive scores of values considered asymptomatic in the Hamilton Rating Scale for Depression (HRSD \<7 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.
Time frame: 8 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sertraline | Number of Participants With Remission to Treatment | 32 Participants |
Secondary
Quality of Life -WHOQOL Intrument Scores
QOL scores as measured by World Heath Organization Quality of Life - WHOQOL -BREF instrument. scores 0-20 . Higher scores means a better outcome. The measure presented is a overall domain with the mean (SD)
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Quality of Life -WHOQOL Intrument Scores | 9.45 score on a scale | Standard Deviation 3.01 |