Trial · NCT02709746
Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years With Major Depressive Disorder (MDD)
NCT02709746, Phase 3, Completed, H. Lundbeck A/S; results first posted 2020-08-19
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years With Major Depressive Disorder (MDD). Trials, record NCT02709746. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02709746
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years With Major Depressive Disorder (MDD)
- NCT number
- NCT02709746
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 784 participants, actual
- Lead sponsor
- H. Lundbeck A/S
- Conditions
- Depressive Disorder, Major
- Interventions
- Vortioxetine 10 mg/day, Vortioxetine 20 mg/day, Fluoxetine 20 mg/day, Placebo
- First posted
- 2016-03-16
- Last updated
- 2020-08-19
- Other registries' IDs
- eudract:2008-005354-20
- Results first posted
- 2020-08-19
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Children Depression Rating Scale - Revised (CDRS-R) Total Score After Treatment | From Randomization to Week 8 | The CDRS-R is a clinician-rated scale to measure the severity of depression of children and adolescents. The CDRS-R consists of 17 items: 14 items rate verbal observations, and three items rate nonverbal observations (tempo of language, hypoactivity, and nonverbal expression of depressed affect). Depression symptoms are rated on a 5-point scale from 1 to 5 for the verbal observations, and a 7-point scale from 1 to 7 for the nonverbal observations. The total score ranges from 17 (normal) to 113 (severe depression). |
| Secondary | Change in CDRS-R Total Score During Treatment (at Week 2) | At week 2 | The CDRS-R is a clinician-rated scale to measure the severity of depression of children and adolescents. The CDRS-R consists of 17 items: 14 items rate verbal observations, and three items rate nonverbal observations (tempo of language, hypoactivity, and nonverbal expression of depressed affect). Depression symptoms are rated on a 5-point scale from 1 to 5 for the verbal observations, and a 7-point scale from 1 to 7 for the nonverbal observations. The total score ranges from 17 (normal) to 113 (severe depression).Children and parents answer separately. Rater judges and selects 'Best'. |
| Secondary | Change in CDRS-R Total Score During Treatment (at Week 4) | At week 4 | The CDRS-R is a clinician-rated scale to measure the severity of depression of children and adolescents. The CDRS-R consists of 17 items: 14 items rate verbal observations, and three items rate nonverbal observations (tempo of language, hypoactivity, and nonverbal expression of depressed affect). Depression symptoms are rated on a 5-point scale from 1 to 5 for the verbal observations, and a 7-point scale from 1 to 7 for the nonverbal observations. The total score ranges from 17 (normal) to 113 (severe depression). |
| Secondary | Change in CDRS-R Total Score During Treatment (at Week 6) | At week 6 | The CDRS-R is a clinician-rated scale to measure the severity of depression of children and adolescents. The CDRS-R consists of 17 items: 14 items rate verbal observations, and three items rate nonverbal observations (tempo of language, hypoactivity, and nonverbal expression of depressed affect). Depression symptoms are rated on a 5-point scale from 1 to 5 for the verbal observations, and a 7-point scale from 1 to 7 for the nonverbal observations. The total score ranges from 17 (normal) to 113 (severe depression). |
| Secondary | Change in CDRS-R Mood Score | From randomization to Week 8 | Change in Children Depression Rating Scale - Revised (CDRS-R) Mood. The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 items. Each item is graded on a 5- or 7-point scale. Mood is one of four subscores defined in the CDRS-R: sum of items 8, 11, 14, 15; score range 4 to 28. The highest possible score indicates the most severe measure of depression. |
| Secondary | Change in CDRS-R Somatic Score | From Randomization to Week 8 | Change in Children Depression Rating Scale - Revised (CDRS-R): Somatic. The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 items. Each item is graded on a 5- or 7-point scale. Somatic is one of four subscores defined in the CDRS-R: sum of items 4, 5, 6, 7, 16, 17; score ranges from 6 to 36. The highest possible score indicates the most severe measure of depression. |
| Secondary | Change in CDRS-R Subjective Score | From Randomization to Week 8 | Change in Children Depression Rating Scale - Revised (CDRS-R): Subjective. The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 items. Each item is graded on a 5- or 7-point scale. Subjective is one of four subscores defined in the CDRS-R: sum of items 9, 10, 12, 13; score ranges from 4 to 28. The highest possible score indicates the most severe measure of depression. |
| Secondary | Change in CDRS-R Behaviour Score | From Randomization to Week 8 | Change in Children Depression Rating Scale - Revised (CDRS-R): Behaviour. The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 items. Each item is graded on a 5- or 7-point scale. behaviour is one of four subscores defined in the CDRS-R:sum of items 1, 2, 3; score ranges from 3 to 21. The highest possible score indicates the most severe measure of depression. |
| Secondary | CDRS-R Response | From Randomization to Week 8 | Children Depression Rating Scale - Response: defined as a \>= 50% decrease in CDRS-R total score, calculated as (change from baseline \[Randomization\])/(baseline value - 17). |
| Secondary | CDRS-R Remission | From Randomization to Week 8 | Remission is defined as a CDRS-R total score \<= 28. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Children Depression Rating Scale - Revised (CDRS-R) Total Score After Treatment | From Randomization to Week 8 | Double-blind treatment period | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in CDRS-R Total Score During Treatment (at Week 2) | At week 2 | Double-blind treatment period. There where overall numbers of participants analyzed are not consistent with numbers provided in the participant flow can be due to particpant flow module total number of patients also includes patients that were enrolled but not treated and other reasons of discontinuation from the study. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in CDRS-R Total Score During Treatment (at Week 4) | At week 4 | Double-blind treatment period. There where overall numbers of participants analyzed are not consistent with numbers provided in the participant flow can be due to particpant flow module total number of patients also includes patients that were enrolled but not treated and other reasons of discontinuation from the study. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in CDRS-R Total Score During Treatment (at Week 6) | At week 6 | Double-blind treatment period. There where overall numbers of participants analyzed are not consistent with numbers provided in the participant flow can be due to particpant flow module total number of patients also includes patients that were enrolled but not treated and other reasons of discontinuation from the study. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in CDRS-R Mood Score | From randomization to Week 8 | Double-blind treatment period. There where overall numbers of participants analyzed are not consistent with numbers provided in the participant flow can be due to particpant flow module total number of patients also includes patients that were enrolled but not treated and other reasons of discontinuation from the study. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in CDRS-R Somatic Score | From Randomization to Week 8 | Double-blind treatment period. There where overall numbers of participants analyzed are not consistent with numbers provided in the participant flow can be due to particpant flow module total number of patients also includes patients that were enrolled but not treated and other reasons of discontinuation from the study. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in CDRS-R Subjective Score | From Randomization to Week 8 | Double-blind treatment period. There where overall numbers of participants analyzed are not consistent with numbers provided in the participant flow can be due to particpant flow module total number of patients also includes patients that were enrolled but not treated and other reasons of discontinuation from the study. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in CDRS-R Behaviour Score | From Randomization to Week 8 | Double-blind treatment period. There where overall numbers of participants analyzed are not consistent with numbers provided in the participant flow can be due to particpant flow module total number of patients also includes patients that were enrolled but not treated and other reasons of discontinuation from the study. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | CDRS-R Response | From Randomization to Week 8 | Double-blind treatment period. There where overall numbers of participants analyzed are not consistent with numbers provided in the participant flow can be due to particpant flow module total number of patients also includes patients that were enrolled but not treated and other reasons of discontinuation from the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | CDRS-R Remission | From Randomization to Week 8 | Double-blind treatment period. There where overall numbers of participants analyzed are not consistent with numbers provided in the participant flow can be due to particpant flow module total number of patients also includes patients that were enrolled but not treated and other reasons of discontinuation from the study. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group113
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Children Depression Rating Scale - Revised (CDRS-R) Total Score After Treatment | Vortioxetine 10 mg/Day | -17.09 | Standard Error 1.27 | units on a scale | |
| Change in Children Depression Rating Scale - Revised (CDRS-R) Total Score After Treatment | Vortioxetine 20 mg/Day | -18.94 | Standard Error 1.22 | units on a scale | |
| Change in Children Depression Rating Scale - Revised (CDRS-R) Total Score After Treatment | Fluoxetine 20 mg/Day, | -21.95 | Standard Error 1.23 | units on a scale | |
| Change in Children Depression Rating Scale - Revised (CDRS-R) Total Score After Treatment | Placebo | -18.22 | Standard Error 1.22 | units on a scale | |
| Change in Children Depression Rating Scale - Revised (CDRS-R) Total Score After Treatment | Vortioxetine Average (Avg. VOR) | -18.01 | Standard Error 0.98 | units on a scale | |
| Change in CDRS-R Total Score During Treatment (at Week 2) | Vortioxetine 10 mg/Day | -9.58 | Standard Error 1.02 | units on a scale | |
| Change in CDRS-R Total Score During Treatment (at Week 2) | Vortioxetine 20 mg/Day | -10.15 | Standard Error 0.99 | units on a scale | |
| Change in CDRS-R Total Score During Treatment (at Week 2) | Fluoxetine 20 mg/Day, | -10.34 | Standard Error 1.00 | units on a scale | |
| Change in CDRS-R Total Score During Treatment (at Week 2) | Placebo | -8.83 | Standard Error 0.98 | units on a scale | |
| Change in CDRS-R Total Score During Treatment (at Week 4) | Vortioxetine 10 mg/Day | -14.32 | Standard Error 1.14 | units on a scale |
1 to 10 of 113Source ClinicalTrials.gov
See all 113 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase A (Single-blind Treatment Period) | STARTED | Single-blind Treatment, Placebo | 784 | |
| Phase A (Single-blind Treatment Period) | STARTED | DBT, Vortioxetine 10 mg | 0 | |
| Phase A (Single-blind Treatment Period) | STARTED | DBT, Vortioxetine 20 mg | 0 | |
| Phase A (Single-blind Treatment Period) | STARTED | DBT, Fluoxetine 20 mg | 0 | |
| Phase A (Single-blind Treatment Period) | STARTED | DBT, Placebo | 0 | |
| Phase A (Single-blind Treatment Period) | COMPLETED | Single-blind Treatment, Placebo | 616 | |
| Phase A (Single-blind Treatment Period) | COMPLETED | DBT, Vortioxetine 10 mg | 0 | |
| Phase A (Single-blind Treatment Period) | COMPLETED | DBT, Vortioxetine 20 mg | 0 | |
| Phase A (Single-blind Treatment Period) | COMPLETED | DBT, Fluoxetine 20 mg | 0 | |
| Phase A (Single-blind Treatment Period) | COMPLETED | DBT, Placebo | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events110
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | SBT, Placebo | 13 | 777 | 14 |
| other | Diarrhoea | Gastrointestinal disorders | DBT, Vortioxetine 10 mg | 5 | 147 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | DBT, Vortioxetine 20 mg | 9 | 161 | 10 |
| other | Diarrhoea | Gastrointestinal disorders | DBT, Fluoxetine 20 mg | 7 | 153 | 11 |
| other | Diarrhoea | Gastrointestinal disorders | DBT, Placebo | 5 | 154 | 5 |
| other | Nausea | Gastrointestinal disorders | SBT, Placebo | 28 | 777 | 31 |
| other | Nausea | Gastrointestinal disorders | DBT, Vortioxetine 10 mg | 21 | 147 | 23 |
| other | Nausea | Gastrointestinal disorders | DBT, Vortioxetine 20 mg | 31 | 161 | 48 |
| other | Nausea | Gastrointestinal disorders | DBT, Fluoxetine 20 mg | 10 | 153 | 16 |
| other | Nausea | Gastrointestinal disorders | DBT, Placebo | 7 | 154 | 9 |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SBT, Placebo | 0 | 777 |
| Total, all-cause mortality | DBT, Vortioxetine 10 mg | 0 | 147 |
| Total, all-cause mortality | DBT, Vortioxetine 20 mg | 0 | 161 |
| Total, all-cause mortality | DBT, Fluoxetine 20 mg | 0 | 153 |
| Total, all-cause mortality | DBT, Placebo | 0 | 154 |
| Total, other adverse events | SBT, Placebo | 128 | 777 |
| Total, other adverse events | DBT, Vortioxetine 10 mg | 47 | 147 |
| Total, other adverse events | DBT, Vortioxetine 20 mg | 57 | 161 |
| Total, other adverse events | DBT, Fluoxetine 20 mg | 40 | 153 |
| Total, other adverse events | DBT, Placebo | 30 | 154 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35033635 | 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.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Symbol Coding | Secondary outcome |
Source ConductCognition
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/NCT02709746
GET https://conductscience.org/api/trials/v1/NCT02709746/registered?page=2