NCT02414503

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 10, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

10 months

First QC Date

March 31, 2015

Last Update Submit

September 26, 2016

Conditions

Autism Spectrum Disorder

Keywords

oxytocinsocial cognition

Outcome Measures

Primary Outcomes (2)

  • Performance on an emotion sensitivity test

    Participants will complete a task evaluating emotional expressions. These stimuli are identical to those published previously by Leknes et al., (2012).

    45 mins after oxytocin/placebo administration

  • Performance on a facial emotion morphing task

    Participants will complete a task evaluating faces that morph into different emotional expressions.

    45 mins after oxytocin/placebo administration

Secondary Outcomes (4)

  • Performance on the reading the mind in the eyes test

    45 mins after oxytocin/placebo administration

  • Performance on an emotional dot probe task

    45 mins after oxytocin/placebo administration

  • Heart rate variability

    40 minutes after oxytocin/placebo administration

  • Eyetracking

    45 mins after oxytocin/placebo administration

Study Arms (3)

8IU intranasal oxytocin

ACTIVE COMPARATOR

8IU intranasal oxytocin delivered with the OptiNose Breath Powered Bi directional liquid device

Drug: 8IU intranasal oxytocinDevice: OptiNose Breath Powered Bi

24IU intranasal oxytocin

ACTIVE COMPARATOR

24IU intranasal oxytocin delivered with the OptiNose Breath Powered Bi directional liquid device

Drug: 24IU intranasal oxytocinDevice: OptiNose Breath Powered Bi

Placebo

PLACEBO COMPARATOR

Placebo delivered with the OptiNose Breath Powered Bi directional liquid device

Drug: PlaceboDevice: OptiNose Breath Powered Bi

Interventions

8IU intranasal oxytocinDRUG
8IU intranasal oxytocin
24IU intranasal oxytocinDRUG
24IU intranasal oxytocin
PlaceboDRUG
Placebo
OptiNose Breath Powered BiDEVICE
24IU intranasal oxytocin8IU intranasal oxytocinPlacebo

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NORMENT, KG Jebsen Centre for Psychosis Research - TOP Study

Oslo, 0424, Norway

Location

Related Publications (1)

  • Leknes S, Wessberg J, Ellingsen DM, Chelnokova O, Olausson H, Laeng B. Oxytocin enhances pupil dilation and sensitivity to 'hidden' emotional expressions. Soc Cogn Affect Neurosci. 2013 Oct;8(7):741-9. doi: 10.1093/scan/nss062. Epub 2012 May 29.

    PMID: 22648957BACKGROUND

Related Links

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Ole A Andreassen, MD, PhD

    University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2015

First Posted

April 10, 2015

Study Start

April 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations

NO(1)