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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sertraline | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sertraline | Drug |
|
| |
| Nortriptyline |
| 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). 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 . | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 months |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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). 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 . | Posted | Count of Participants | Participants | 8 weeks |
|
18 months
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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 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| D.r. Ana Flávia Barros da Silva Lima | Universidade Federal do Rio Grande do Sul | 51999185180 | afbslima@gmail.com.br |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| D009661 | Nortriptyline |
| D008094 | Lithium |
| D016651 | Lithium Carbonate |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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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.
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| Drug |
|
|
| Lithium | Drug |
|
|
| 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) | 12 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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. | Posted | Count of Participants | Participants | 8 months |
|
|
|
| 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) | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| 0 |
| 68 |
| 0 |
| 68 |
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| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
| D008670 | Metals |
| D002254 | Carbonates |
| D000468 | Alkalies |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D018020 | Lithium Compounds |