Trial · NCT01254045
Double-blind Placebo Controlled Study of Oxytocin in Fragile X Syndrome
NCT01254045, Phase 2, Completed, Stanford University; results first posted 2014-08-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Double-blind Placebo Controlled Study of Oxytocin in Fragile X Syndrome. Trials, record NCT01254045. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01254045
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Double-blind Placebo Controlled Study of Oxytocin in Fragile X Syndrome
- NCT number
- NCT01254045
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Fragile X Syndrome
- Interventions
- placebo, oxytocin 24IU, oxytocin 48IU
- First posted
- 2010-12-06
- Last updated
- 2020-03-18
- Results first posted
- 2014-08-29
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Eye Contact/Gaze During 10 Minute Social Challenge Task | baseline, week 2, and week 3 | Number of times that eye gaze occurred (i.e., participant looked at female experimenter in the eyes) during 10 minute social challenge task (first 5 minutes social proximity, second 5 minutes social interaction). The social challenge task occurred 50 minutes after internasal dose (of placebo, placebo + oxytocin, or oxytocin) at baseline, week 2, and week 3 visits. |
| Secondary | Salivary Cortisol | baseline, week 2, and week 3 | salivary cortisol level measured immediately before social challenge task and 20 minutes following social challenge task at each time point (i.e., baseline, week 2, and week 3) |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Eye Contact/Gaze During 10 Minute Social Challenge Task | baseline, week 2, and week 3 | eye contact/gaze events per 10 minutes | MEAN | |
| SECONDARY | Salivary Cortisol | baseline, week 2, and week 3 | nmol/L | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Eye Contact/Gaze During 10 Minute Social Challenge Task | Placebo | 15.4 | Standard Error 3.5 | eye contact/gaze events per 10 minutes | |
| Eye Contact/Gaze During 10 Minute Social Challenge Task | Oxytocin 24IU/Placebo 24IU | 20.9 | Standard Error 3.6 | eye contact/gaze events per 10 minutes | |
| Eye Contact/Gaze During 10 Minute Social Challenge Task | 48IU OT | 17.0 | Standard Error 4.5 | eye contact/gaze events per 10 minutes | |
| Salivary Cortisol | Placebo | 6.33 | Standard Error .86 | nmol/L | |
| Salivary Cortisol | 24IU OT | 4.67 | Standard Error .56 | nmol/L | |
| Salivary Cortisol | 48IU OT | 4.37 | Standard Error .92 | nmol/L |
Source ClinicalTrials.gov
Participant flow54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First/Baseline (1 Day at Week 1 ) | STARTED | Placebo 48IU, Oxytocin 24IU/Placebo 24IU, Oxytocin 48IU | 2 | |
| First/Baseline (1 Day at Week 1 ) | STARTED | Oxytocin 24IU/Placebo 24IU, Placebo 48IU, Oxytocin 48IU | 2 | |
| First/Baseline (1 Day at Week 1 ) | STARTED | Oxytocin 48IU, Oxytocin 24IU/Placebo 24IU, Placebo 48IU | 2 | |
| First/Baseline (1 Day at Week 1 ) | STARTED | Oxytocin 24IU/Placebo 24IU, Oxytocin 48IU, Placebo 48IU | 1 | |
| First/Baseline (1 Day at Week 1 ) | STARTED | Oxytocin 48IU, Placebo 48IU, Oxytocin 24IU/Placebo 24IU | 1 | |
| First/Baseline (1 Day at Week 1 ) | STARTED | Placebo 48IU, Oxytocin 48IU, Oxytocin 24IU/Placebo 24IU | 1 | |
| First/Baseline (1 Day at Week 1 ) | COMPLETED | Placebo 48IU, Oxytocin 24IU/Placebo 24IU, Oxytocin 48IU | 1 | |
| First/Baseline (1 Day at Week 1 ) | COMPLETED | Oxytocin 24IU/Placebo 24IU, Placebo 48IU, Oxytocin 48IU | 2 | |
| First/Baseline (1 Day at Week 1 ) | COMPLETED | Oxytocin 48IU, Oxytocin 24IU/Placebo 24IU, Placebo 48IU | 2 | |
| First/Baseline (1 Day at Week 1 ) | COMPLETED | Oxytocin 24IU/Placebo 24IU, Oxytocin 48IU, Placebo 48IU | 1 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 participant flowAdverse events3
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 | Bell's palsy | Nervous system disorders | Intervention: Placebo 48IU | 0 | 8 | 0 |
| other | Bell's palsy | Nervous system disorders | Intervention: Oxytocin 24IU/Placebo 24IU | 1 | 8 | 1 |
| other | Bell's palsy | Nervous system disorders | Intervention: Oxytocin 48IU | 0 | 8 | 0 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intervention: Placebo 48IU | ||
| Total, all-cause mortality | Intervention: Oxytocin 24IU/Placebo 24IU | ||
| Total, all-cause mortality | Intervention: Oxytocin 48IU | ||
| Total, other adverse events | Intervention: Placebo 48IU | 0 | 8 |
| Total, other adverse events | Intervention: Oxytocin 24IU/Placebo 24IU | 1 | 8 |
| Total, other adverse events | Intervention: Oxytocin 48IU | 0 | 8 |
| Total, serious adverse events | Intervention: Placebo 48IU | 0 | 8 |
| Total, serious adverse events | Intervention: Oxytocin 24IU/Placebo 24IU | 0 | 8 |
| Total, serious adverse events | Intervention: Oxytocin 48IU | 0 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21862226 | RESULT |
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/NCT01254045
GET https://conductscience.org/api/trials/v1/NCT01254045/flow?page=2