UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A multicenter, parallel group, placebo-controlled, double blind, confirmatory trial of intranasal oxytocin in participants with autism spectrum disorders
Title of the study (Brief title)	A multicenter confirmatory trial of intranasal oxytocin in participants with autism spectrum disorders
Region	Japan

Condition
Condition	Autism spectrum disorders
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	1) To confirm efficacy of intranasal oxytocin on a core symptom of autism spectrum disorders, deficit in social reciprocity, in parallel group comparison 2) To test time-course change in the efficacy for consideration of optimized treatment duration 3) To develop molecular bio-markers for prediction of treatment outcomes and uncovering the mechanisms of therapeutic effect
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Changes in scores of social reciprocity in Autism Diagnostic Observation Schedule administered just before and after double blind treatment period
Key secondary outcomes	Changes in scores of communication and restricted and repetitive behavior in Autism Diagnostic Observation Schedule administered just before and after double blind treatment period State and Trait Anxiety Inventory and Center for Epidemiologic Studies Depression Scale assessed just before and after double blind treatment period DNA-methylations analyzed from whole-genome analysis using peripheral bloods collected just before and after double blind treatment period Eye gaze assessed just before and after double blind treatment period Facial and voice expressions analyzed from videos recorded in every two weeks during trial period Clinical Global Impression and Global Assessment of Functioning assessed in every two weeks during trial period

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration of 48 IU/day intranasal oxytocin for twice per day, six weeks
Interventions/Control_2	Intranasal administration of placebo for twice per day, six weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	55 years-old >
Gender	Male
Key inclusion criteria	1) Diagnosed as autistic disorder or Asperger's disorder or pervasive developmental disorder not-otherwise-specified based on DSM-IV-TR 2) Exceeded cutoff for qualitative abnormalities in reciprocal social interaction (Domain A) in Autism Diagnostic Interview-Revised 3) Verbal IQ above 85 and Full IQ above 80 measured with Wechsler Adult Intelligent Scale-III
Key exclusion criteria	1) Primary psychiatric diagnosis other than inclusion criteria 1) 2) Current instability due to a comorbid psychiatric diagnosis 3) History of changes in medications or medication doses of psychotropics within one month of randomization 4) Under current treatment with psychotropics more than two categories 5) Under current treatment with atomoxetine or methylphenidate 6) History of continual treatment of oxytocin 7) History of sensitivity to oxytocin 8) History of seizures or traumatic brain injury with loss of consciousness for longer than 5 minutes 9) History of alcoholics or substance abuse or addiction
Target sample size	114

Research contact person
Name of lead principal investigator	Hidenori Yamasue
Organization	The University of Tokyo Hospital
Division name	Department of Neuropsychiatry
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Email	yamasue-tky@umin.ac.jp

Public contact
Name of contact person	Hidenori Yamasue
Organization	The University of Tokyo Hospital
Division name	Department of Neuropsychiatry
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Homepage URL
Email	yamasue-tky@umin.ac.jp

Sponsor
Institute	Department of Neuropsychiatry, The University of Tokyo Hospital
Institute
Department

Funding Source
Organization	The Strategic Research Program for Brain Sciences
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kanazawa University Hospital, Nagoya University Hospital, University of Fukui Hospital
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	P2014032-11X
Org. issuing International ID_1	The University of Tokyo Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	金沢大学附属病院（石川県）、名古屋大学医学部附属病院（愛知県）、福井大学医学部附属病院（福井県）、東京大学医学部附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 18 Day
Anticipated trial start date	2014 Year 10 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 09 Month 26 Day
Last modified on	2017 Year 02 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017703