A Phase 2 interventional study of Syntocinon and Placebo in Autism and ASD, sponsored by Alexander Kolevzon. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-04-15.
Sponsored by Alexander Kolevzon · Phase 2, Interventional, and Basic science
This study examines the effects of a single dose of intranasal oxytocin (vs. placebo) on complex social cognition in adults with autism spectrum disorders.
Participants receive a one-time administration of 24-IU intranasal oxytocin (or placebo) and perform an empathic accuracy task, a novel and ecologically valid measure of complex social cognition, in conjunction with functional magnetic resonance imaging (fMRI). The investigators will investigate the effects of oxytocin (versus placebo) on the behavioral and neural correlates of empathic accuracy.
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's enrollment of 30 is below the median of 49 across 811 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Alexander Kolevzon is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
24IU intranasal oxytocin, minimum of 3 weeks off, then placebo
Drug: Syntocinon · Drug: Placebo
Placebo, minimum of 3 weeks off, then 24IU intranasal oxytocin or placebo
Drug: Syntocinon · Drug: Placebo
One dose of 24 IU (3 sprays/nostril)
Also known as: Intranasal oxytocin
Intranasal Placebo
Empathic Accuracy Performance
Participants watch videos of targets describing positive and negative autobiographical events and provide continuous ratings of how positive-negative the target is feeling on a 9-point Likert scale. Empathic accuracy is operationalized as a timecourse correlation between perceiver inferences about target affect and targets' own affect ratings.
Time frame: 45 minutes after drug/placebo administration
Fmri BOLD Response During Empathic Accuracy Task
Images will be acquired using a 3.0 Tesla Siemens Allegra MRI scanner equipped to acquire gradient-echo, echoplanar T2\*-weighted images (EPI) with blood oxygenation level dependent (BOLD) contrast. Each volume will comprise 26 axial slices of 4.5mm thickness and a 3.5 x 3.5mm in-plane resolution, aligned along the AC-PC axis. Volumes will be acquired continuously every 2 seconds. Each run will begin with 5 'dummy' volumes, which will be discarded from further analyses. At the end of the scanning session, a T-1 weighted structural image will be acquired from each participant.
Time frame: 45 minutes after oxytocin/placebo administration
| Milestone | Syntocinon Then Placebo | Placebo Then Syntocinon |
|---|---|---|
| Started | 15 | 15 |
| Completed | 15 | 15 |
| Not completed | 0 | 0 |
| Milestone | Syntocinon Then Placebo | Placebo Then Syntocinon |
|---|---|---|
| Started | 15 | 15 |
| Completed | 14 | 14 |
| Not completed | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Milestone | Syntocinon Then Placebo | Placebo Then Syntocinon |
|---|---|---|
| Started | 14 | 14 |
| Completed | 14 | 14 |
| Not completed | 0 | 0 |
Participants watch videos of targets describing positive and negative autobiographical events and provide continuous ratings of how positive-negative the target is feeling on a 9-point Likert scale. Empathic accuracy is operationalized as a timecourse correlation between perceiver inferences about target affect and targets' own affect ratings.
No measurements were reported for this outcome.
Images will be acquired using a 3.0 Tesla Siemens Allegra MRI scanner equipped to acquire gradient-echo, echoplanar T2\*-weighted images (EPI) with blood oxygenation level dependent (BOLD) contrast. Each volume will comprise 26 axial slices of 4.5mm thickness and a 3.5 x 3.5mm in-plane resolution, aligned along the AC-PC axis. Volumes will be acquired continuously every 2 seconds. Each run will begin with 5 'dummy' volumes, which will be discarded from further analyses. At the end of the scanning session, a T-1 weighted structural image will be acquired from each participant.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Syntocinon | 0/28 (0%) | 0/28 (0%) | 8/28 (28.6%) |
| Placebo | 0/28 (0%) | 0/28 (0%) | 10/28 (35.7%) |
| Event | Syntocinon | Placebo |
|---|---|---|
| HeadacheGeneral disorders | 4/28 | 2/28 |
| FatigueGeneral disorders | 2/28 | 1/28 |
| Watery eyesEndocrine disorders | 1/28 | 2/28 |
| Burning in throat after nasal sprayRespiratory, thoracic and mediastinal disorders | 2/28 | 0/28 |
| Sinuses tenderBlood and lymphatic system disorders | 2/28 | 0/28 |
| Lack of focusPsychiatric disorders | 1/28 | 2/28 |
| Felt body/joint painMusculoskeletal and connective tissue disorders | 2/28 | 2/28 |
| Runny noseRespiratory, thoracic and mediastinal disorders | 2/28 | 2/28 |
| Ringing EarsEar and labyrinth disorders | 0/28 | 1/28 |
| Shortness of BreathRespiratory, thoracic and mediastinal disorders | 1/28 | 0/28 |
| Age, Continuous(years) | Syntocinon Then Placebo | Placebo Then Syntocinon | Total |
|---|---|---|---|
| Mean | 30.7 ± 8.9 | 27.5 ± 6.7 | 29.3 ± 7.7 |
| Sex: Female, Male(Participants) | Syntocinon Then Placebo | Placebo Then Syntocinon | Total |
|---|---|---|---|
| Female | 4 | 3 | 7 |
| Male | 10 | 11 | 21 |
| Ethnicity (NIH/OMB)(Participants) | Syntocinon Then Placebo | Placebo Then Syntocinon | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 3 | 5 |
| Not Hispanic or Latino | 12 | 11 | 23 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Syntocinon Then Placebo | Placebo Then Syntocinon | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 11 | 9 | 20 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 3 | 5 |
Ran from Jun 2010 to primary completion in Apr 2014, 46 months.
Results were first posted in Apr 2021, 6 years 11 months after primary completion.
Of 35 non-industry phase 2 interventional studies under Autistic Disorder, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 63. This study's 46 months is close to that.
Counting every sponsor, half of 44 studies reached it within 39 months; a quarter within 24 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Oxytocin
Alexander Kolevzon