Trial · NCT05073679
Oral Naltrexone In Pediatric Eating Disorders
NCT05073679, Phase 2, Phase 3, Terminated, Rosemary Claire Roden; results first posted 2025-08-19
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Oral Naltrexone In Pediatric Eating Disorders. Trials, record NCT05073679. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05073679
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Naltrexone In Pediatric Eating Disorders
- NCT number
- NCT05073679
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 9 participants, actual
- Lead sponsor
- Rosemary Claire Roden
- Conditions
Anorexia Nervosa/Bulimia, Anorexia in Adolescence, Anorexia Nervosa, Atypical, Anorexia Nervosa, Binge Eating/Purging Type, Purging (Eating Disorders), Impulsive Behavior, Eating Disorders, Bulimia Nervosa, Eating Disorders in Adolescence
- Interventions
- Naltrexone Hydrochloride, Control
- First posted
- 2021-10-11
- Last updated
- 2025-08-19
- Results first posted
- 2025-08-19
- Limitations and caveats
Limitations and caveats include low participant sample and participant attrition. No outcome data collected for outcome measures 48, 49, 50, 51, and 59 because participants were lost to follow-up at those time points.
Source ClinicalTrials.gov
Registered outcomes62
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ED-15 Score | Time Frame: Measured at the following timepoints: enrollment | ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology. |
| Primary | ED-15 Score | Time Frame: Measured at the following timepoints: one week | ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology. |
| Primary | ED-15 Score | Time Frame: Measured at the following timepoints: three week | ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology. |
| Primary | ED-15 Score | Time Frame: Measured at the following timepoints: six weeks | ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology. |
| Primary | ED-15 Score | Time Frame: Measured at the following timepoints: nine weeks (last week of treatment) | ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology. |
| Primary | ED-15 Score | Time Frame: Measured at the following timepoints: 6 months after enrollment | ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology. |
| Secondary | Eating Disorder Examination Questionnaire Score (EDE-Q) | Measured at the following timepoints: enrollment | EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology. |
| Secondary | Eating Disorder Examination Questionnaire Score (EDE-Q) | Measured at the following timepoints: one week | EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology. |
| Secondary | Eating Disorder Examination Questionnaire Score (EDE-Q) | Measured at the following timepoints: three weeks | EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology. |
| Secondary | Eating Disorder Examination Questionnaire Score (EDE-Q) | Measured at the following timepoints: six weeks | EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology. |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 registered outcomesOutcomes62
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | ED-15 Score | Time Frame: Measured at the following timepoints: enrollment | Numbers represent participants enrolled at this time point. | score on a scale | MEAN |
| PRIMARY | ED-15 Score | Time Frame: Measured at the following timepoints: one week | Numbers represent participants enrolled at this time point. | score on a scale | MEAN |
| PRIMARY | ED-15 Score | Time Frame: Measured at the following timepoints: three week | Numbers represent participants enrolled at this time point. | score on a scale | MEAN |
| PRIMARY | ED-15 Score | Time Frame: Measured at the following timepoints: six weeks | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | score on a scale | MEAN |
| PRIMARY | ED-15 Score | Time Frame: Measured at the following timepoints: nine weeks (last week of treatment) | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | score on a scale | MEAN |
| PRIMARY | ED-15 Score | Time Frame: Measured at the following timepoints: 6 months after enrollment | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | score on a scale | MEAN |
| SECONDARY | Eating Disorder Examination Questionnaire Score (EDE-Q) | Measured at the following timepoints: enrollment | Numbers represent participants enrolled at this time point. | score on a scale | MEAN |
| SECONDARY | Eating Disorder Examination Questionnaire Score (EDE-Q) | Measured at the following timepoints: one week | Numbers represent participants enrolled at this time point. | score on a scale | MEAN |
| SECONDARY | Eating Disorder Examination Questionnaire Score (EDE-Q) | Measured at the following timepoints: three weeks | Numbers represent participants enrolled at this time point. | score on a scale | MEAN |
| SECONDARY | Eating Disorder Examination Questionnaire Score (EDE-Q) | Measured at the following timepoints: six weeks | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | score on a scale | MEAN |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 outcomesResults by group186
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| ED-15 Score | Intervention | 3.5 | Standard Deviation 2.016184515 | score on a scale | |
| ED-15 Score | Control | 4.7 | Standard Deviation 0.871779789 | score on a scale | |
| ED-15 Score | Intervention | 3.08 | Standard Deviation 1.845806057 | score on a scale | |
| ED-15 Score | Control | 4.675 | Standard Deviation 0.784750491 | score on a scale | |
| ED-15 Score | Intervention | 3.04 | Standard Deviation 1.820164828 | score on a scale | |
| ED-15 Score | Control | 4.025 | Standard Deviation 1.508586535 | score on a scale | |
| ED-15 Score | Intervention | 1.825 | Standard Deviation 1.701714821 | score on a scale | |
| ED-15 Score | Control | 3.5 | Standard Deviation 2.364318084 | score on a scale | |
| ED-15 Score | Intervention | 1.075 | Standard Deviation 0.736545993 | score on a scale | |
| ED-15 Score | Control | 4.5 | Standard Deviation 0 | score on a scale |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intervention | 5 | |
| Overall Study | STARTED | Control | 4 | |
| Overall Study | COMPLETED | Intervention | 5 | |
| Overall Study | COMPLETED | Control | 4 | |
| Overall Study | NOT COMPLETED | Intervention | 0 | |
| Overall Study | NOT COMPLETED | Control | 0 |
Source ClinicalTrials.gov
Adverse events20
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 | Increase in Medication | Psychiatric disorders | Intervention | 1 | 5 | 1 |
| other | Increase in Medication | Psychiatric disorders | Control | 0 | 4 | 0 |
| other | Less Headaches | General disorders | Intervention | 1 | 5 | 1 |
| other | Less Headaches | General disorders | Control | 0 | 4 | 0 |
| other | Nausea | Gastrointestinal disorders | Intervention | 2 | 5 | 2 |
| other | Nausea | Gastrointestinal disorders | Control | 0 | 4 | 0 |
| other | Headache | General disorders | Intervention | 0 | 5 | 0 |
| other | Headache | General disorders | Control | 1 | 4 | 1 |
| other | Sweating | Endocrine disorders | Intervention | 1 | 5 | 1 |
| other | Sweating | Endocrine disorders | Control | 0 | 4 | 0 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intervention | 0 | 5 |
| Total, all-cause mortality | Control | 0 | 4 |
| Total, other adverse events | Intervention | 3 | 5 |
| Total, other adverse events | Control | 4 | 4 |
| Total, serious adverse events | Intervention | 0 | 5 |
| Total, serious adverse events | Control | 1 | 4 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intervention vs Control: deaths from any cause | Trial comparisons |
| Intervention vs Control: serious adverse events | Trial comparisons |
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT05073679
GET https://conductscience.org/api/trials/v1/NCT05073679/registered?page=2