UMIN-CTR Clinical Trial

Public title

Effects of long-term administration of intranasal oxytocin on autism spectrum disorders

Acronym

Effects of long-term administration of intranasal oxytocin on autism spectrum disorders

Scientific Title

Effects of long-term administration of intranasal oxytocin on autism spectrum disorders

Scientific Title:Acronym

Effects of long-term administration of intranasal oxytocin on autism spectrum disorders

Region

Japan

Condition

Autism
Pervasive developmental disorders

Classification by specialty

Pediatrics

Psychiatry

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

To determine the effects on the behavior and side effects of long-term,daily administration of oxytocin on children with autism spectrum disorders.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The outcome measures are Abberant Behavior Checklist(ABC),Child Behavior Checklist(CBCL),Social Responsiveness Scale(SRS) completed by the caregivers and eye tracking tested before the administration of nasal oxytocin and at the end of each term(placebo or oxytocin).
In addition,we will analyze mutations of CD38.

Key secondary outcomes

The second outocome measures are blood pressure,urine osmolarity,urine sodium concentration and oxytocin concentration of his second urine in the morning.They are measured every time the participant comes to the hospital during the trial.

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No need to know

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

In Arm 1, the subjects will receive 24IU/dose of intranasal oxytocin (Syntocinon Nasal Spray, NOVARTIS) administration twice daily for one month followed by one week washout period.Then they will receive the placebo (in the same type of containers that are used for oxytocin) twice daily for one month.

Interventions/Control_2

In Arm 2, the subjects will receive placebo (in the same type of containers that are used for oxytocin) twice daily for one month followed by one week washout period. Then they will receive 24IU/dose of intranasal oxytocin (Syntocinon Nasal Spray, NOVARTIS) administration twice daily for one month.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

6

years-old

<=

Age-upper limit

9

years-old

>=

Gender

Male

Key inclusion criteria

All participants will be recruited from the outpatients of Osaka Univercity hospital if they meet the inclusion criteria as follows;1) having clinical diagnosis for autism spectrum disorders as assessed by use of DSM-4-TR (Text Revision of the Diagnostic and Statistical Manual of Mental Disorders,4th edition),and 2) having IQ between 35-75.

Key exclusion criteria

We will exclude patients with cardio vascular disease.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Masako Taniike

Organization

Osaka University United Graduate School of Child Development

Division name

Department of Child Development

Zip code

Address

2-2 Yamadaoka,Suita City,Osaka,Japan

TEL

06-6879-3863

Email

masako@kokoro.med.osaka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Ikuko Hirata

Organization

Osaka University Graduate School of Medicine

Division name

Department of Pediatrics

Zip code

Address

2-2 Yamadaoka,Suita City,Osaka,Japan

TEL

06-6879-3863

Homepage URL

Email

masako@kokoro.med.osaka-u.ac.jp

Institute

Osaka University Hospital

Institute

Department

Personal name

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪大学医学部附属病院

Date of disclosure of the study information

2012

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Terminated

Date of protocol fixation

2012

Year

09

Month

21

Day

Date of IRB

Anticipated trial start date

2012

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

10

Month

10

Day

Last modified on

2014

Year

10

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010649