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

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ClinicalTrials.gov Identifier: NCT02414503
Recruitment Status : Completed
First Posted : April 10, 2015
Last Update Posted : September 27, 2016
Sponsor:
Collaborators:
Oslo University Hospital
University of Oslo
Information provided by (Responsible Party):
OptiNose AS

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Drug: 8IU intranasal oxytocin Drug: 24IU intranasal oxytocin Drug: Placebo Device: OptiNose Breath Powered Bi Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Randomized, Placebo Controlled, Double-blind, 3-period Cross-over Study in Adult Patients With Autism Spectrum Disorders Evaluating Cognitive Response After Single- Dose Oxytocin 8 or 24 IU Intranasal Administration Using the OptiNose Bi-directional Nose-to-brain Device
Study Start Date : April 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016


Arm Intervention/treatment
Active Comparator: 8IU intranasal oxytocin
8IU intranasal oxytocin delivered with the OptiNose Breath Powered Bi directional liquid device
Drug: 8IU intranasal oxytocin
Device: OptiNose Breath Powered Bi
Active Comparator: 24IU intranasal oxytocin
24IU intranasal oxytocin delivered with the OptiNose Breath Powered Bi directional liquid device
Drug: 24IU intranasal oxytocin
Device: OptiNose Breath Powered Bi
Placebo Comparator: Placebo
Placebo delivered with the OptiNose Breath Powered Bi directional liquid device
Drug: Placebo
Device: OptiNose Breath Powered Bi



Primary Outcome Measures :
  1. Performance on an emotion sensitivity test [ Time Frame: 45 mins after oxytocin/placebo administration ]
    Participants will complete a task evaluating emotional expressions. These stimuli are identical to those published previously by Leknes et al., (2012).

  2. Performance on a facial emotion morphing task [ Time Frame: 45 mins after oxytocin/placebo administration ]
    Participants will complete a task evaluating faces that morph into different emotional expressions.


Secondary Outcome Measures :
  1. Performance on the reading the mind in the eyes test [ Time Frame: 45 mins after oxytocin/placebo administration ]
    Participants will complete the reading the mind in the eyes test

  2. Performance on an emotional dot probe task [ Time Frame: 45 mins after oxytocin/placebo administration ]
    Participants will complete an emotional dot probe task

  3. Heart rate variability [ Time Frame: 40 minutes after oxytocin/placebo administration ]
    Electrocardiogram data will be collected to assess heart rate variability, a measure of cardiac autonomic function.

  4. Eyetracking [ Time Frame: 45 mins after oxytocin/placebo administration ]
    An eyetracking device will measure eyegaze and pupillometry.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414503


Locations
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Norway
NORMENT, KG Jebsen Centre for Psychosis Research - TOP Study
Oslo, Norway, 0424
Sponsors and Collaborators
OptiNose AS
Oslo University Hospital
University of Oslo
Investigators
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Principal Investigator: Ole A Andreassen, MD, PhD University of Oslo
Additional Information:
Publications:
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Responsible Party: OptiNose AS
ClinicalTrials.gov Identifier: NCT02414503    
Other Study ID Numbers: SMR-2728
2014-005452-26 ( EudraCT Number )
First Posted: April 10, 2015    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Keywords provided by OptiNose AS:
oxytocin
social cognition
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs