DepressionPhase 4NCT02901249
Cost- Effectiveness and Quality of Life Assessment in Major Depression Disorder
A Phase 4 study testing sertraline, Nortriptyline and Lithium in people with Depression, run by Federal University of Rio Grande do Sul.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- sertraline, Nortriptyline and Lithium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Sep 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ages between 18 and 65;
- current acute unipolar depression episode;
- total capacity to understand and respond to self-applied instruments;
- the presence of symptoms in the last 30 days;
- abstinence for at least 30 days for drug addicts
Who cannot join
- presence of Organic Brain Syndrome (OBS);
- pregnancy or lactation;
- criteria for psychiatric hospitalization.
About this study
Official title: Assessment of Cost- Effectiveness Interventions and the Quality of Life in Patients With Major Depression Through Resources Available in Brazilian Public Health
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.
Read the 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:
- Sample selection by being referred from the primary healthcare clinics in the municipality;
- Informative talk about mood disorders and the research, with the informed consent forms being provided to the subjects;
- Screening for unipolar depression episodes with the use of the Patient Health Questionnaire (PHQ-9), and Hypomanic Symptoms Checklist Brazilian Version (HCL -32-BV);
- Diagnostic evaluation through the Mini International Neuropsychiatric Interview (MINI) and clinical interview for individuals with positive results in the screening instruments;
- Baseline and demographic assessments using standardized semi-structured interviews in the first and second visits;
- 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);
- Biweekly follow-up, changed to monthly after stabilization - with a maximum follow-up period of 52 weeks.
- Conditions
- Depression
- Being tested
- sertraline, Nortriptyline, Lithium
- Keywords
- Cost effectiveness, Unipolar Depression, Major Depression Disorder, Quality of life disorder
- Medical subject headings
- Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sertralineDrug
Also called Cloridrate of sertraline
NortriptylineDrug
Also called Cloridrate of nortrytyline
LithiumDrug
Also called Lithium Carbonate
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: sertraline; Drug: Nortriptyline; Drug: Lithium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 8 weeks
Secondary outcomes (2)
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.
Measured: 8 months
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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startMay 2010
- Primary completionNov 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Flávia Barros da Silva Lima, Federal University of Rio Grande do Sul
- Investigators
- Marcelo Fleck, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901249
- Sponsor's protocol ID
- 017/2009
- Status last verified
- Aug 2016
- First submitted
- 11 Sep 2016
- Last updated
- 14 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28832750
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cost- Effectiveness Interventions and the Quality of Life in Patients With Major Depression Through Resources Available in Brazilian Public Health
- ClinicalTrials.gov ID
- NCT02901249
- Acronym / sponsor ID
- 017/2009
- Conditions
- Depression
- Keywords
- Cost effectiveness, Unipolar Depression, Major Depression Disorder, Quality of life disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 15 Sep 2016 (estimated)
- Results
- Posted 14 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Sample selection by being referred from the primary healthcare clinics in the municipality;
- Informative talk about mood disorders and the research, with the informed consent forms being provided to the subjects;
- Screening for unipolar depression episodes with the use of the Patient Health Questionnaire (PHQ-9), and Hypomanic Symptoms Checklist Brazilian Version (HCL -32-BV);
- Diagnostic evaluation through the Mini International Neuropsychiatric Interview (MINI) and clinical interview for individuals with positive results in the screening instruments;
- Baseline and demographic assessments using standardized semi-structured interviews in the first and second visits;
- 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);
- Biweekly follow-up, changed to monthly after stabilization - with a maximum follow-up period of 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sertraline | Experimental | Drug: sertraline, Drug: Nortriptyline, Drug: LithiumGroup 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ages between 18 and 65;
- current acute unipolar depression episode;
- total capacity to understand and respond to self-applied instruments;
- the presence of symptoms in the last 30 days;
- abstinence for at least 30 days for drug addicts
Key exclusion criteria (3 listed)
- presence of Organic Brain Syndrome (OBS);
- pregnancy or lactation;
- criteria for psychiatric hospitalization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sertralineAlso: Cloridrate of sertraline | Drug | Sertraline |
| NortriptylineAlso: Cloridrate of nortrytyline | Drug | Sertraline |
| LithiumAlso: Lithium Carbonate | Drug | Sertraline |
Primary outcome
Number of Participants With Response to Treatment
Time frame: 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 .
2 secondary outcomes
Number of Participants With Remission to Treatment
Time frame: 8 months
Quality of Life -WHOQOL Intrument Scores
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28832750Lima 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.
- Individual participant dataSharing planned: No
Related trials for Depression
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Recruiting
Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples
Anxiety, Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelo Fleck, PhD principal investigator
Federal University of Rio Grande do Sul
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sertraline, Nortriptyline and Lithium in people with Depression, run by Federal University of Rio Grande do Sul.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Response to Treatment (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02901249, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020; AzTrials last refreshed its copy on 8 Nov 2026.