Trial · NCT02901249
Cost- Effectiveness and Quality of Life Assessment in Major Depression Disorder
NCT02901249, Phase 4, Completed, Federal University of Rio Grande do Sul; results first posted 2020-10-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cost- Effectiveness and Quality of Life Assessment in Major Depression Disorder. Trials, record NCT02901249. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02901249
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cost- Effectiveness and Quality of Life Assessment in Major Depression Disorder
- NCT number
- NCT02901249
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 68 participants, actual
- Lead sponsor
- Federal University of Rio Grande do Sul
- Conditions
- Depression
- Interventions
- sertraline, Nortriptyline, Lithium
- First posted
- 2016-09-15
- Last updated
- 2020-10-14
- Results first posted
- 2020-10-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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) |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Response to Treatment | 8 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Remission to Treatment | 8 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Quality of Life -WHOQOL Intrument Scores | 12 weeks | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Response to Treatment | Sertraline | 58 | Participants | ||
| Number of Participants With Remission to Treatment | Sertraline | 32 | Participants | ||
| Quality of Life -WHOQOL Intrument Scores | Sertraline | 9.45 | Standard Deviation 3.01 | score on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sertraline | 68 | |
| Overall Study | COMPLETED | Sertraline | 43 | |
| Overall Study | NOT COMPLETED | Sertraline | 25 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sertraline | ||
| Total, other adverse events | Sertraline | 0 | 68 |
| Total, serious adverse events | Sertraline | 0 | 68 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28832750 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02901249
GET https://conductscience.org/api/trials/v1/NCT02901249/registered