Trial · NCT01624194
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Parent Rated Social Responsiveness Scale (SRS) Scores During Treatment. | Baseline; Week 4 | Social Responsiveness Scale (SRS) raw scores measure social abilities with lower raw scores meaning better social abilities. (Raw Score Range: 0 - 195) |
| Secondary | Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment | Baseline through Week 4 | Dosage Record Treatment Emergent Symptom Scale (DOTES) side effects reported by parents during 4-weeks of treatment. Participant Counts are used. |
| Secondary | Change From Baseline in Height. | Baseline; Week 4 | |
| Secondary | Clinical Global Impression-Improvement (CGI-I) Score at Week 4 | Baseline to Week 4 | This outcome is reported as the count of participants in each CGI-I rating category at the week 4 visit, assessing change over the 4-week period. CGI-I rating of 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7=Very Much Worse. |
| Secondary | Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4 | Baseline; Week 4 | Higher scores indicate more symptoms, lower scores indicate fewer symptoms. Irritability scores can range from 0-45. Lethargy scores can range from 0-48. Stereotypy scores can range from 0-21. Hyperactivity scores can range from 0-48. Inappropriate speech scores can from 0-12. |
| Secondary | Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. | Baseline; Week 4 | Scale measuring severity of anxiety symptoms. Higher scores mean higher levels of anxiety, lower scores mean lower levels of anxiety. (Raw Score Range: 0 - 114) |
| Secondary | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition - Social and Communication Subscales During Treatment. | Baseline; Week 4 | Higher Social Standard Score means better social skills, lower Social Standard Score means worse social skills. Higher Communication Standard Score means better communication skills, lower Communication Standard Score means worse communication skills. Standard Scores can range from 20 to 160. |
| Secondary | Change From Baseline in Laboratory Based Facial Emotion Recognition Abilities During Treatment. | Up to 4 weeks | |
| Secondary | Change From Baseline in Laboratory Based Eye-gaze to Social Cues During Treatment. | Baseline; Week 4 | |
| Secondary | Change From Baseline in Reading the Mind in the Eyes Test, Child Version (RMET-child) Scores During Treatment. | Up to 4 weeks | |
| Secondary | Change From Baseline in Laboratory Based Social Mimicry Abilities During Treatment. | Up to 4 weeks | |
| Secondary | Change From Baseline in Developmental NEuroPSYchological Assessment (NEPSY-II) Affect Recognition Scores During Treatment. | Baseline; Week 4 | Higher Affect Recognition scores mean better affect recognition abilities, lower Affect Recognition scores mean worse affect recognition abilities. Scores can range from 1 to 19. |
| Secondary | Change From Baseline in Plasma Oxytocin Levels During Treatment. | Up to 4 weeks | This outcome originally specified that oxytocin, vasopressin, and cortisol levels would be assessed; however, data on vasopressin and cortisol levels were not collected during the study. There are no clinical laboratory tests that establish a normative range for oxytocin. Measurements prior to and following treatment were intended to evaluate oxytocin level as a predictor of response. |
| Secondary | Change From Baseline in Parent Rated Repetitive Behavior Scale- Revised (RBS-R) Scores During Treatment. | Baseline; Week 4 | Higher scores on the Repetitive Behavior Scale- Revised mean higher levels of repetitive and restricted behaviors. (Raw Score Total Range: 0 - 129) |
| Secondary | Change From Baseline in Weight | Baseline; Week 4 | |
| Secondary | Change From Baseline in Heart Rate | Baseline; Week 4 | |
| Secondary | Change From Baseline in Blood Pressure | Baseline; Week 4 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT01624194/registered