ASD, Autism Spectrum Disorder, PDD, Pervasive Developmental Disorder
Conditions
Keywords
Autism Spectrum Disorders, Pervasive Developmental Disorder, ASD, PDD, Oxytocin, Syntocinon, Social Impairment, Treatment
Brief summary
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.
Interventions
DRUGIntranasal 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).
Sponsors
Massachusetts General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Males and females between 12 and 55 years of age. * Meets the DSM-5 diagnostic criteria for Autism Spectrum Disorder (ASD) as established by clinical diagnostic interview * At least moderate severity of ASD impairment as measured by a raw score of ≥85 on the SRS * Participants and their parent/guardian must be able to speak and understand English sufficiently to comprehend the nature of the study and to allow for the completion of all study procedures required per protocol. * Subjects and their parent/guardian must be considered reliable reporters. They must understand the nature of the study and must sign an IRB-approved informed consent form before initiation of any study procedures. Subjects and their parent/guardian must have a level of understanding sufficient to communicate with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol. * Each subject and their parent/guardian must understand the nature of the study and provide written informed assent/consent. * Subjects with mood, anxiety, or disruptive behavior disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria. * If the subject is sexually active, he/she must agree to use an acceptable form of birth control during the study. These include: * Abstinence (no sexual contact) * A barrier method (diaphragm plus spermicide or a condom plus spermicide) in addition to one of the following methods: * Consistent use of an approved birth control pill * Birth control patch * Injected contraceptives * Intrauterine device (IUD)
Exclusion criteria
* Impaired intellectual functioning and/or impaired spoken language. * Clinically unstable psychiatric conditions or any serious medical illness, which will be assessed by study clinicians during the psychiatric interview and medical history review. If the clinical assessment suggests a psychiatric or medical condition demanding acute clinical attention, then the subject will be excluded from participating in the trial. * Clinically unstable psychiatric conditions. * Any serious medical illness * Pregnant or nursing females. * Known hypersensitivity to oxytocin. * Severe allergies or multiple adverse drug reactions. * A non-responder or history of intolerance to oxytocin, after treatment at adequate doses as determined by the clinician. * Subjects with significant nasal pathology (including atrophic rhinitis, recurrent nose bleeds, and history of hypophysectomy). * Clinically abnormal baseline laboratory values falling significantly outside of the standard reference ranges for a basic metabolic screen. * Investigator and his/her immediate family defined as the investigator's spouse, parent, child, grandparent, or grandchild. * Currently enrolled or recently participated (within the past 6 months) in a clinical trial of intranasal oxytocin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ASD Symptoms Social Responsiveness Scale 2 (SRS-2) Scale From Baseline to Week 8 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxytocin- Participants Ages 12-17 Participants 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). | 2 |
| Oxytocin- Participants Ages 18-55 Participants 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). | 5 |
| Total | 7 |
Baseline characteristics
| Characteristic | Oxytocin- Participants Ages 18-55 | Total | Oxytocin- Participants Ages 12-17 |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 0 Participants |
| Age, Continuous | 30.0 years STANDARD_DEVIATION 8.7 | 25.3 years STANDARD_DEVIATION 10 | 13.5 years STANDARD_DEVIATION 2.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 7 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 7 Participants | 2 Participants |
| Region of Enrollment United States | 5 participants | 7 participants | 2 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 5 |
| other Total, other adverse events | 1 / 2 | 3 / 5 |
| serious Total, serious adverse events | 0 / 2 | 0 / 5 |
Outcome results
Primary
Change in ASD Symptoms Social Responsiveness Scale 2 (SRS-2) Scale From Baseline to Week 8
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin- Participants Ages 12-17 | Change in ASD Symptoms Social Responsiveness Scale 2 (SRS-2) Scale From Baseline to Week 8 | -39.5 scores on a scale | Standard Deviation 12 |
| Oxytocin- Participants Ages 18-55 | Change in ASD Symptoms Social Responsiveness Scale 2 (SRS-2) Scale From Baseline to Week 8 | -29 scores on a scale | Standard Deviation 9.8 |