Trial · NCT00965419
A Study of Pediatric Participants With Attention Deficit/Hyperactivity Disorder
NCT00965419, Phase 2, Phase 3, Terminated, Eli Lilly and Company; results first posted 2018-04-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Pediatric Participants With Attention Deficit/Hyperactivity Disorder. Trials, record NCT00965419. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00965419
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Pediatric Participants With Attention Deficit/Hyperactivity Disorder
- NCT number
- NCT00965419
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 267 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Edivoxetine
- First posted
- 2009-08-25
- Last updated
- 2019-10-08
- Results first posted
- 2018-04-27
- Limitations and caveats
- Terminated due to low 5 year completer number and not meeting primary objective.
Source ClinicalTrials.gov
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With At Least One Serious Adverse Events (SAE) Over the Duration of the Study | Baseline Through Week 252 | Percentage of Participants experienced at least one SAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. |
| Primary | Number of Participants With At Least One SAE | Baseline Through Week 252 | Number of Participants experienced at least one SAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. |
| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | Baseline Through Week 252 | Percentage of Participants had at least one TEAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. |
| Secondary | Number of Participants With At Least One TEAE | Baseline Through Week 252 | Number of participants had at least one TEAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. |
| Secondary | Percentage of Participants With Discontinuation Due to Adverse Events (DCAEs) | Baseline Through Week 252 | |
| Secondary | Number of Participants With At Least One DCAEs | Baseline Through Week 252 | |
| Secondary | Percentage of Participants Who Discontinued Due to Any Reason | Baseline Through Week 252 | |
| Secondary | Number of Participants Who Discontinued Due to Any Reason | Baseline Through Week 252 | |
| Secondary | Percentage of Participants With Columbia-Suicide Severity Rating Scale (CSSRS) for Each Category | Baseline Through Week 252, Baseline, 1-month (mo) Follow-Up (f/u) | Percentage of Participants in each category of CSSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Participants with suicidal ideation were those who had yes to any of the following questions: Wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act, without specific plan, and active suicidal ideation with specific plan and intent. Suicidal behavior included those who had yes to any of the following questions: Preparatory acts or behavior, Aborted attempt, Interrupted attempt, Non-fatal suicide attempt, Completed suicide. |
| Secondary | Mean Change From Baseline Z-scores for Height | Baseline, Week 60; Baseline, Week 240 | A z-score is the number of standard deviations a data point is from the mean. Z-scores range from -3 standard deviations (far left of the mean in normal distribution curve) up to +3 standard deviations (far right of the mean in normal distribution curve). |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 registered outcomesOutcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With At Least One Serious Adverse Events (SAE) Over the Duration of the Study | Baseline Through Week 252 | All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline SAE assessment. | percentage of participants | NUMBER |
| PRIMARY | Number of Participants With At Least One SAE | Baseline Through Week 252 | All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline SAE assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | Baseline Through Week 252 | All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline TEAE assessment. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With At Least One TEAE | Baseline Through Week 252 | All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline TEAE assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Discontinuation Due to Adverse Events (DCAEs) | Baseline Through Week 252 | All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With At Least One DCAEs | Baseline Through Week 252 | All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline DCAE assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Who Discontinued Due to Any Reason | Baseline Through Week 252 | All enrolled participants who had evaluable discontinuation data. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants Who Discontinued Due to Any Reason | Baseline Through Week 252 | All enrolled participants who had evaluable discontinuation data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Columbia-Suicide Severity Rating Scale (CSSRS) for Each Category | Baseline Through Week 252, Baseline, 1-month (mo) Follow-Up (f/u) | All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CSSRS assessment. | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline Z-scores for Height | Baseline, Week 60; Baseline, Week 240 | All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline Z-score assessment. | Z-Score | MEAN |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 outcomesResults by group208
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With At Least One Serious Adverse Events (SAE) Over the Duration of the Study | Edivoxetine | 2.65 | percentage of participants | ||
| Number of Participants With At Least One SAE | Edivoxetine | 7 | Participants | ||
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | Edivoxetine | 76.89 | percentage of participants | ||
| Number of Participants With At Least One TEAE | Edivoxetine | 203 | Participants | ||
| Percentage of Participants With Discontinuation Due to Adverse Events (DCAEs) | Edivoxetine | 12.50 | percentage of participants | ||
| Number of Participants With At Least One DCAEs | Edivoxetine | 33 | Participants | ||
| Percentage of Participants Who Discontinued Due to Any Reason | Edivoxetine | 92.51 | Percentage of participants | ||
| Number of Participants Who Discontinued Due to Any Reason | Edivoxetine | 247 | Participants | ||
| Percentage of Participants With Columbia-Suicide Severity Rating Scale (CSSRS) for Each Category | Edivoxetine | 0-5 Years (Suicidal Ideation) | 5.68 | percentage of participants | |
| Percentage of Participants With Columbia-Suicide Severity Rating Scale (CSSRS) for Each Category | Edivoxetine | 0-5 Years (Suicidal Behavior) | 0.00 | percentage of participants |
1 to 10 of 208Source ClinicalTrials.gov
See all 208 results by groupParticipant flow7
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open Label Treatment for Responders | STARTED | Edivoxetine | 267 | |
| Open Label Treatment for Responders | Not Lost to f/u at First Post-baseline | Edivoxetine | 264 | |
| Open Label Treatment for Responders | COMPLETED | Edivoxetine | 20 | |
| Open Label Treatment for Responders | NOT COMPLETED | Edivoxetine | 247 | |
| Follow-up Phase | STARTED | Edivoxetine | 80 | |
| Follow-up Phase | COMPLETED | Edivoxetine | 18 | |
| Follow-up Phase | NOT COMPLETED | Edivoxetine | 62 |
Source ClinicalTrials.gov
Adverse events44
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 | Abdominal pain upper | Gastrointestinal disorders | Edivoxetine (Open-Label) | 22 | 264 | 28 |
| other | Abdominal pain upper | Gastrointestinal disorders | Edivoxetine (Follow Up) | 2 | 80 | 2 |
| other | Nausea | Gastrointestinal disorders | Edivoxetine (Open-Label) | 35 | 264 | 48 |
| other | Nausea | Gastrointestinal disorders | Edivoxetine (Follow Up) | 0 | 80 | 0 |
| other | Vomiting | Gastrointestinal disorders | Edivoxetine (Open-Label) | 45 | 264 | 69 |
| other | Vomiting | Gastrointestinal disorders | Edivoxetine (Follow Up) | 0 | 80 | 0 |
| other | Fatigue | General disorders | Edivoxetine (Open-Label) | 16 | 264 | 19 |
| other | Fatigue | General disorders | Edivoxetine (Follow Up) | 0 | 80 | 0 |
| other | Gastroenteritis viral | Infections and infestations | Edivoxetine (Open-Label) | 15 | 264 | 17 |
| other | Gastroenteritis viral | Infections and infestations | Edivoxetine (Follow Up) | 0 | 80 | 0 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Edivoxetine (Open-Label) | ||
| Total, all-cause mortality | Edivoxetine (Follow Up) | ||
| Total, other adverse events | Edivoxetine (Open-Label) | 155 | 264 |
| Total, other adverse events | Edivoxetine (Follow Up) | 5 | 80 |
| Total, serious adverse events | Edivoxetine (Open-Label) | 7 | 264 |
| Total, serious adverse events | Edivoxetine (Follow Up) | 1 | 80 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Edivoxetine (Open-Label) vs Edivoxetine (Follow Up): serious adverse events |
Source Trial comparisons
Tests5
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 | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Letter-Number Sequencing Task | Secondary outcome | ConductCognition |
| Matrix Reasoning | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Symbol Scan Task | Secondary outcome | 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/NCT00965419
GET https://conductscience.org/api/trials/v1/NCT00965419/registered?page=2