Trial · NCT02629991
Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome
NCT02629991, Phase 2, Completed, Montefiore Medical Center; results first posted 2021-10-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome. Trials, record NCT02629991. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02629991
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome
- NCT number
- NCT02629991
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- Montefiore Medical Center
- Conditions
- Prader-Willi Syndrome, Hyperphagia
- Interventions
- Intranasal Oxytocin (IN-OXT), Matched Placebo
- First posted
- 2015-12-15
- Last updated
- 2021-10-07
- Results first posted
- 2021-10-07
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hyperphagia Questionnaire (HQ)- Total Score | Assessed trends over multiple time points (weeks 0, 2, 4, 6, and 8), week 0 (baseline), week 4 and week 8 are reported. | The Hyperphagia Questionnaire (HQ)- Total Score. The HQ is a 11-item clinician-rated instrument that was designed to measure food related behaviors in PWS. Items map onto 3 subscales; Hyperphagic Behavior, Hyperphagic Drive, and Hyperphagia Severity. The subscales are summed together to compute the Total Score. The Total Score ranges from 11-55, with higher scores indicating more hyperphagia and a worse outcome. |
| Primary | Hyperphagia Questionnaire (HQ)- Behavior Factor Score | Assessed trends over multiple time points (weeks 0, 2, 4, 6, and 8), week 0 (baseline), week 4 and week 8 are reported. | The Hyperphagia Questionnaire (HQ)- Behavior Factor Score assesses food seeking behaviors (e.g., stealing food). The Behavior Factor Score ranges from 5-25, with higher scores indicating more hyperphagic behaviors and a worse outcome. |
| Primary | Hyperphagia Questionnaire (HQ)- Drive Factor Score | Assessed trends over multiple time points (weeks 0, 2, 4, 6, and 8), week 0 (baseline), week 4 and week 8 are reported. | The Hyperphagia Questionnaire (HQ)- Drive Factor Score assesses the persistence in asking for food. The Drive Factor Score ranges from 4-20, with higher scores indicating higher hyperphagic drive and a worse outcome |
| Primary | Hyperphagia Questionnaire (HQ) -Severity Factor Score | Assessed trends over multiple time points (weeks 0, 2, 4, 6, and 8), week 0 (baseline), week 4 and week 8 are reported. | The Hyperphagia Questionnaire (HQ)- Severity Factor Score assesses the severity of hyperphagia. The Severity Factor Score ranges from 2-10, with higher scores indicating higher severity. |
| Secondary | Repetitive Behavior Scale-Revised (RBS-R) Ritualistic Behavior Factor Score | Trends over multiple time points (Weeks 0, 4, and 8). | The Repetitive Behavior Scale-Revised (RBS-R) Ritualistic Behavior Factor Score assesses ritualistic behaviors. Scores range from 0-18, with higher scores indicating more ritualistic behaviors and a worse outcome. |
| Secondary | Repetitive Behavior Scale-Revised (RBS-R) Sameness Factor Score | Trends over multiple time points (Weeks 0, 4, and 8). | The Repetitive Behavior Scale-Revised (RBS-R) Sameness Factor Score assesses the need for sameness in the environment. Scores range from 0-33, with higher scores indicating more need for sameness and a worse outcome. |
| Secondary | Repetitive Behavior Scale-Revised (RBS-R) Stereotyped Behavior Factor Score | Trends over multiple time points (Weeks 0, 4, and 8). | The Repetitive Behavior Scale-Revised (RBS-R) Stereotyped Behavior Factor Score assesses stereotyped behaviors. Scores range from 0-18, with higher scores indicating more stereotyped behaviors and a worse outcome. |
| Secondary | Repetitive Behavior Scale-Revised (RBS-R) Compulsive Behavior Factor Score | Trends over multiple time points (Weeks 0, 4, and 8). | The Repetitive Behavior Scale-Revised (RBS-R) Compulsive Behavior Factor Score assesses compulsive behaviors. Scores range from 0-24, with higher scores indicating more compulsive behaviors and a worse outcome. |
| Secondary | Repetitive Behavior Scale-Revised (RBS-R) Self-Injurious Factor Score | Trends over multiple time points (Weeks 0, 4, and 8). | The Repetitive Behavior Scale-Revised (RBS-R) Self-Injurious Factor Score assesses self-injurious behaviors. Scores range from 0-24, with higher scores indicating more self-injurious behaviors and a worse outcome. |
| Secondary | Repetitive Behavior Scale-Revised (RBS-R) Restricted Interest Factor Score | Trends over multiple time points (Weeks 0, 4, and 8). | The Repetitive Behavior Scale-Revised (RBS-R) Restricted Interest Factor Score assesses restricted interests. Scores range from 0-12, with higher scores indicating more restricted interests and a worse outcome. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Hyperphagia Questionnaire (HQ)- Total Score | Assessed trends over multiple time points (weeks 0, 2, 4, 6, and 8), week 0 (baseline), week 4 and week 8 are reported. | 1 subject discontinued oxytocin early and 1 subject discontinued placebo early | score on a scale | MEAN |
| PRIMARY | Hyperphagia Questionnaire (HQ)- Behavior Factor Score | Assessed trends over multiple time points (weeks 0, 2, 4, 6, and 8), week 0 (baseline), week 4 and week 8 are reported. | 1 subject discontinued oxytocin early and 1 subject discontinued placebo early | score on a scale | MEAN |
| PRIMARY | Hyperphagia Questionnaire (HQ)- Drive Factor Score | Assessed trends over multiple time points (weeks 0, 2, 4, 6, and 8), week 0 (baseline), week 4 and week 8 are reported. | 1 subject discontinued oxytocin early and 1 subject discontinued placebo early | score on a scale | MEAN |
| PRIMARY | Hyperphagia Questionnaire (HQ) -Severity Factor Score | Assessed trends over multiple time points (weeks 0, 2, 4, 6, and 8), week 0 (baseline), week 4 and week 8 are reported. | 1 subject discontinued oxytocin early and 1 subject discontinued placebo early | score on a scale | MEAN |
| SECONDARY | Repetitive Behavior Scale-Revised (RBS-R) Ritualistic Behavior Factor Score | Trends over multiple time points (Weeks 0, 4, and 8). | 1 subject discontinued oxytocin early and 1 subject discontinued placebo early | score on a scale | MEAN |
| SECONDARY | Repetitive Behavior Scale-Revised (RBS-R) Sameness Factor Score | Trends over multiple time points (Weeks 0, 4, and 8). | 1 subject discontinued oxytocin early and 1 subject discontinued placebo early | score on a scale | MEAN |
| SECONDARY | Repetitive Behavior Scale-Revised (RBS-R) Stereotyped Behavior Factor Score | Trends over multiple time points (Weeks 0, 4, and 8). | 1 subject discontinued oxytocin early and 1 subject discontinued placebo early | score on a scale | MEAN |
| SECONDARY | Repetitive Behavior Scale-Revised (RBS-R) Compulsive Behavior Factor Score | Trends over multiple time points (Weeks 0, 4, and 8). | 1 subject discontinued oxytocin early and 1 subject discontinued placebo early | score on a scale | MEAN |
| SECONDARY | Repetitive Behavior Scale-Revised (RBS-R) Self-Injurious Factor Score | Trends over multiple time points (Weeks 0, 4, and 8). | 1 subject discontinued oxytocin early and 1 subject discontinued placebo early | score on a scale | MEAN |
| SECONDARY | Repetitive Behavior Scale-Revised (RBS-R) Restricted Interest Factor Score | Trends over multiple time points (Weeks 0, 4, and 8). | 1 subject discontinued oxytocin early and 1 subject discontinued placebo early | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Hyperphagia Questionnaire (HQ)- Total Score | Intranasal Oxytocin | Baseline | 27.91 | Standard Deviation 10.77 | score on a scale |
| Hyperphagia Questionnaire (HQ)- Total Score | Matched Placebo | Baseline | 30.58 | Standard Deviation 8.08 | score on a scale |
| Hyperphagia Questionnaire (HQ)- Total Score | Intranasal Oxytocin | Week 4 | 27.4 | Standard Deviation 9.85 | score on a scale |
| Hyperphagia Questionnaire (HQ)- Total Score | Matched Placebo | Week 4 | 23.33 | Standard Deviation 8.41 | score on a scale |
| Hyperphagia Questionnaire (HQ)- Total Score | Intranasal Oxytocin | Week 8 | 26.91 | Standard Deviation 11.67 | score on a scale |
| Hyperphagia Questionnaire (HQ)- Total Score | Matched Placebo | Week 8 | 25.09 | Standard Deviation 9.86 | score on a scale |
| Hyperphagia Questionnaire (HQ)- Behavior Factor Score | Intranasal Oxytocin | Baseline | 9.55 | Standard Deviation 5.01 | score on a scale |
| Hyperphagia Questionnaire (HQ)- Behavior Factor Score | Matched Placebo | Baseline | 9.75 | Standard Deviation 3.47 | score on a scale |
| Hyperphagia Questionnaire (HQ)- Behavior Factor Score | Intranasal Oxytocin | Week 4 | 9.4 | Standard Deviation 4.27 | score on a scale |
| Hyperphagia Questionnaire (HQ)- Behavior Factor Score | Matched Placebo | Week 4 | 7.22 | Standard Deviation 2.64 | score on a scale |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intranasal Oxytocin | 11 | |
| Overall Study | STARTED | Matched Placebo | 12 | |
| Overall Study | COMPLETED | Intranasal Oxytocin | 10 | |
| Overall Study | COMPLETED | Matched Placebo | 11 | |
| Overall Study | NOT COMPLETED | Intranasal Oxytocin | 1 | |
| Overall Study | NOT COMPLETED | Matched Placebo | 1 |
Source ClinicalTrials.gov
Adverse events50
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 | Fatigue | General disorders | Intranasal Oxytocin (IN-OXT) | 2 | 11 | 2 |
| other | Fatigue | General disorders | Matched Placebo | 2 | 12 | 2 |
| other | Increased Thirst | General disorders | Intranasal Oxytocin (IN-OXT) | 0 | 11 | 0 |
| other | Increased Thirst | General disorders | Matched Placebo | 1 | 12 | 1 |
| other | Nocturia | Renal and urinary disorders | Intranasal Oxytocin (IN-OXT) | 2 | 11 | 2 |
| other | Nocturia | Renal and urinary disorders | Matched Placebo | 1 | 12 | 1 |
| other | Insomnia | Psychiatric disorders | Intranasal Oxytocin (IN-OXT) | 1 | 11 | 1 |
| other | Insomnia | Psychiatric disorders | Matched Placebo | 0 | 12 | 0 |
| other | Increased cataplexy | Nervous system disorders | Intranasal Oxytocin (IN-OXT) | 1 | 11 | 1 |
| other | Increased cataplexy | Nervous system disorders | Matched Placebo | 0 | 12 | 0 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intranasal Oxytocin (IN-OXT) | 0 | 11 |
| Total, all-cause mortality | Matched Placebo | 0 | 12 |
| Total, other adverse events | Intranasal Oxytocin (IN-OXT) | 7 | 11 |
| Total, other adverse events | Matched Placebo | 7 | 12 |
| Total, serious adverse events | Intranasal Oxytocin (IN-OXT) | 0 | 11 |
| Total, serious adverse events | Matched Placebo | 0 | 12 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intranasal Oxytocin (IN-OXT) vs Matched Placebo: deaths from any cause | Trial comparisons |
| Intranasal Oxytocin (IN-OXT) vs Matched Placebo: 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.
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/NCT02629991
GET https://conductscience.org/api/trials/v1/NCT02629991/results?page=2