Trial · NCT02918097
Cost- Effectiveness and Quality of Life Assessment in Bipolar Disorder Depressive Episode
NCT02918097, 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 Bipolar Disorder Depressive Episode. Trials, record NCT02918097. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02918097
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 Bipolar Disorder Depressive Episode
- NCT number
- NCT02918097
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 78 participants, actual
- Lead sponsor
- Federal University of Rio Grande do Sul
- Conditions
- Bipolar Disorder
- Interventions
- Lithium Carbonate, Sertraline, Nortriptyline, Risperidone
- First posted
- 2016-09-28
- Last updated
- 2020-11-20
- 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)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 |
| Primary | Quality of Life Instrument Scores | 12 weeks | Quality of Life - WHOQOL -BREF instrument scores scores 0-20 . higher scores mean a better outcome. |
| Secondary | 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). |
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 | |
| PRIMARY | Quality of Life Instrument Scores | 12 weeks | score on a scale | MEAN | |
| SECONDARY | Number of Participants With Remission to Treatment | 8 months | Participants | COUNT_OF_PARTICIPANTS |
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 | Lithium Carbonate | 65 | Participants | ||
| Quality of Life Instrument Scores | Lithium Carbonate | 10.58 | Standard Deviation 3.64 | score on a scale | |
| Number of Participants With Remission to Treatment | Lithium Carbonate | 21 | Participants |
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 | Lithium Carbonate | 78 | |
| Overall Study | COMPLETED | Lithium Carbonate | 58 | |
| Overall Study | NOT COMPLETED | Lithium Carbonate | 20 |
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 | Lithium Carbonate | 0 | 78 |
| Total, other adverse events | Lithium Carbonate | 0 | 78 |
| Total, serious adverse events | Lithium Carbonate | 0 | 78 |
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/NCT02918097
GET https://conductscience.org/api/trials/v1/NCT02918097/registered