Trial · Interventional

CompletedPhase 1/2Registry data

Effects of Intranasal Administration of a Single Dose of Oxytocin Using a Novel Device in Adults With Autism Spectrum Disorder

NCTNCT02414503Other idSMR-2728Other id2014-005452-26Other id2014

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1/2
Enrollment: 17 participants (actual)
Sponsor: OptiNose AS · Industry
Design: Randomized · Triple masking
Countries: 1 country
Norway
Start: Apr 2015
Primary completion: Feb 2016
Completion: Feb 2016
First posted: 10 Apr 2015 (estimated)
Last update posted: 27 Sept 2016 (estimated)
Conditions: Autism Spectrum Disorder

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201520162017

Ph 1/2
Effects of Intranasal Administration of a Single Dose of Oxytocin Using a Novel Device in Adults With Autism Spectrum Disorder
NCT02414503
Apr 2015 to Feb 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Oxytocin (OT) is a small, naturally occurring peptide currently in clinical use to stimulate lactation in breastfeeding women. The intranasal administration of OT has recently attracted attention as a potential novel treatment in several psychiatric disorders in autism. However, given the anatomy of the nasal cavity, the current design of nasal sprays would be expected to provide an inadequate delivery of medication to the areas of the nasal cavity where direct transport into the brain via the olfactory nerve could potentially occur. OptiNose has developed an intranasal delivery device that provides improved reproducibility of nasal delivery, improved deposition to the upper posterior regions of the nasal cavity where the olfactory nerve innervates the nasal cavity. The primary objective of this study is to identify any differences between a single dose of 8 international units (IU) oxytocin, 24 IU oxytocin, and placebo delivered intranasally with the optimised OptiNose device in volunteers with Autism Spectrum Disorder. This will be measured in terms of performance on cognitive tests and physiological markers.

Interventions

8IU intranasal oxytocinDrug
24IU intranasal oxytocinDrug
PlaceboDrug
OptiNose Breath Powered BiDevice

Arms3

Active comparator
8IU intranasal oxytocin
8IU intranasal oxytocin delivered with the OptiNose Breath Powered Bi directional liquid device
Active comparator
24IU intranasal oxytocin
24IU intranasal oxytocin delivered with the OptiNose Breath Powered Bi directional liquid device
Placebo comparator
Placebo
Placebo delivered with the OptiNose Breath Powered Bi directional liquid device

Primary outcomes2

Outcomes the sponsor listed as primary.

Performance on an emotion sensitivity test
Time frame · 45 mins after oxytocin/placebo administration
Registry description
Participants will complete a task evaluating emotional expressions. These stimuli are identical to those published previously by Leknes et al., (2012).
Performance on a facial emotion morphing task
Time frame · 45 mins after oxytocin/placebo administration
Registry description
Participants will complete a task evaluating faces that morph into different emotional expressions.

Secondary outcomes(4)

Performance on the reading the mind in the eyes test
Time frame · 45 mins after oxytocin/placebo administration
Registry description
Participants will complete the reading the mind in the eyes test
Performance on an emotional dot probe task
Time frame · 45 mins after oxytocin/placebo administration
Registry description
Participants will complete an emotional dot probe task
Heart rate variability
Time frame · 40 minutes after oxytocin/placebo administration
Registry description
Electrocardiogram data will be collected to assess heart rate variability, a measure of cardiac autonomic function.
Eyetracking
Time frame · 45 mins after oxytocin/placebo administration
Registry description
An eyetracking device will measure eyegaze and pupillometry.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2013

4 results

Oxytocin enhances pupil dilation and sensitivity to 'hidden' emotional expressions.

Leknes et al. 2013Social cognitive and affective neurosciencecited by 94

PMID 22648957PMC3791062DOI 10.1093/scan/nss062PUB-22648957

Free to read · publisher termsCC BY-NC4 results

Read at source See results (4)

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years up to 35 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Male subjects between the ages of 18 and 35, both inclusive, with a confirmed diagnosis of autism spectrum disorder (ASD) diagnosis. * Subjects must be in good general health, as determined by the investigator. * Subject's pre-study physical examination, vital signs and electrocardiogram (ECG) must not show any clinically significant abnormalities as determined by the investigator. * Subjects must be able to communicate well with the Investigator, to understand and comply with the requirements of the study, and to understand the oral and written patient information * Provision of a signed, written informed consent. Exclusion Criteria: * Subjects showing major septal deviation or a significantly altered nasal epithelium. * Subjects with evidence of previous nasal disease, surgery, and dependence on inhaled drugs. * Subjects with current significant nasal congestion due to common colds. * Subjects with a clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, pulmonary, haematological or metabolic disorder. * Psychiatric co-morbidity that requires intervention (e.g., psychosis spectrum disorders, suicide intent) * Systemic illness requiring treatment within 2 weeks prior to Study Day 1. * History of significant drug or alcohol abuse (as per WHO Alcohol use disorder identification test and drug use disorder identification test criteria) Subjects with a positive screen for alcohol or drugs of abuse at screening/admission will be excluded from participation in the study. * Abnormal laboratory values which is deemed clinically significant by investigator. * Full scale IQ \< 75 (due to the prerequisite ability to complete self report measures). * Known allergic reactions or hypersensitivity to any component of the study medication in the nasal spray, such as propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218) and chlorobutanol hemihydrate. * Participation in any (other) clinical trial with an investigational medicinal product or medical device within 3 months prior to randomisation. * Other unspecified reasons that, in the opinion of the investigator or the sponsor make the subject unsuitable for enrollment.

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