Change in ASD Symptoms Social Responsiveness Scale 2 (SRS-2) Scale From Baseline to Week 8
| Group | Value (scores on a scale) | Spread |
|---|---|---|
| Oxytocin- Participants Ages 12-17 | -39.5 | 12 |
| Oxytocin- Participants Ages 18-55 | -29 | 9.8 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
A Study of Oxytocin for the Treatment of Social Impairment in Individuals With High Functioning Autism Spectrum Disorder
NCT029857499 Oct 2017 to 9 Jan 2019
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study is an 8-week pilot trial with oxytocin nasal spray (Syntocinon) as a treatment for social impairment in children and adults with high functioning autism spectrum disorders (ASD). The investigators hypothesize that oxytocin will be safe, tolerable, and effective in improving social deficits in individuals with ASD.
Experimental
Oxytocin- Participants ages 12-17
Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks.
Experimental
Oxytocin- Participants ages 18-55
Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks.
Outcomes the sponsor listed as primary.
Change in ASD Symptoms Social Responsiveness Scale 2 (SRS-2) Scale From Baseline to Week 8
Time frame · 8 weeks
Change in ASD symptoms as measured by change from baseline on the Social Responsiveness Scale 2 (SRS-2) scale. The SRS-2 is a 65-item rating scale completed that is used to measure the severity of autism spectrum symptoms as they occur in natural settings. The SRS-2 School Age form is completed by a parent or guardian for patients ages 9-17 and the SRS-2 Adult Self-report is completed by patients ages 18-59. Total raw scores range from 0 to 195, with higher scores indicating increased symptom severity.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (scores on a scale) | Spread |
|---|---|---|
| Oxytocin- Participants Ages 12-17 | -39.5 | 12 |
| Oxytocin- Participants Ages 18-55 | -29 | 9.8 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Oxytocin- Participants Ages 12-17Participants ages 12-17 enrolled to receive oxytocin treatment Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks. Intranasal Oxytocin: This study is examining the short-term efficacy and tolerability of intranasal oxytocin for the treatment of social impairment in youths and adults with high-functioning ASD (HF-ASD). | 0 / 2 | 0 / 2 | 1 / 2 |
| Oxytocin- Participants Ages 18-55Participants ages 18-55 enrolled to receive oxytocin treatment Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks. Intranasal Oxytocin: This study is examining the short-term efficacy and tolerability of intranasal oxytocin for the treatment of social impairment in youths and adults with high-functioning ASD (HF-ASD). | 0 / 5 | 0 / 5 | 3 / 5 |
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