NCT02007447

Brief Summary

This study is design to evaluate the influence of oxytocin in some aspects of Autism Spectrum Disorder (ASD), such as, repetitive and stereotyped behavior, social skills, quality of life and disruptive behaviors. Null hypothesis: social skills, quality of life, disruptive behaviors and repetitive behaviors do not improve with the use of oxytocin. Experimental Hypothesis: social skills, quality of life, disruptive behaviors and repetitive and stereotyped behaviors improve with the use of oxytocin.

Trial Health

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Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2013

Completed
1.5 years until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2018

Completed
Last Updated

October 28, 2019

Status Verified

October 1, 2019

Enrollment Period

2 months

First QC Date

December 5, 2013

Last Update Submit

October 24, 2019

Conditions

Autism Spectrum Disorder

Keywords

autism, oxytocin, autism spectrum disorder, social skills.

Outcome Measures

Primary Outcomes (1)

  • SOCIAL SKILLS

    Evaluation of social skills: Matson Evaluation of Social Skills (MESSY): consisting of 62 items divided into six factors that assess social skills such as appropriate social skills, assertiveness inadequate, impulsivity, self-confidence, jealousy withdraw, and other items that do not fit another classification.

    8 weeks

Secondary Outcomes (1)

  • REPETITIVE BEHAVIOR

    8 WEEKS

Other Outcomes (2)

  • Evaluation disruptive behavior: Vineland, just the part that assess disruptive behavior

    8 WEEKS

  • Multidimensional Student's Life Satisfaction Scale (MSLSS)

    8 WEEKS

Study Arms (2)

OCYTOCINA - SPRAY NASAL

ACTIVE COMPARATOR

OCYTOCINA - SPRAY NASAL - 24Ui twice per day for 8 weeks

Drug: OCYTOCINA - SPRAY NASAL

Placebo

PLACEBO COMPARATOR

Placebo - twice per day for 8 weeks

Drug: OCYTOCINA - SPRAY NASAL

Interventions

OCYTOCINA - SPRAY NASALDRUG

The initial sample is divided into two groups (A and B): group A receive oxytocin intranasal for 8 weeks 24UI twice a day (3 applications per nostril 4UI 12/12 hours); group B will receive placebo for 8 weeks

Also known as: SYNTOCINON - SPRAY NASAL, OXYTOCIN
OCYTOCINA - SPRAY NASALPlacebo

Eligibility Criteria

Age12 Years - 18 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male
  • Age between 11 years 11 months and 17 years 11 months
  • Autism spectrum disorder according to DSM V
  • ADI \> 10
  • WISC \> 70
  • CARS \> 30

You may not qualify if:

  • Female
  • presence of genetic and neurological syndromes
  • changes in drugs or in any intervention during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute os Psychiatry, Clinical Hospital at São Paulo

São Paulo, 05043-903, Brazil

Location

Related Publications (1)

  • Tachibana M, Kagitani-Shimono K, Mohri I, Yamamoto T, Sanefuji W, Nakamura A, Oishi M, Kimura T, Onaka T, Ozono K, Taniike M. Long-term administration of intranasal oxytocin is a safe and promising therapy for early adolescent boys with autism spectrum disorders. J Child Adolesc Psychopharmacol. 2013 Mar;23(2):123-7. doi: 10.1089/cap.2012.0048. Epub 2013 Mar 12.

    PMID: 23480321BACKGROUND

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic DisorderSocial Skills

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Helena P. Brentani, PHD

    University of Sao Paulo General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Helena Paula Brentani

Study Record Dates

First Submitted

December 5, 2013

First Posted

December 10, 2013

Study Start

June 1, 2015

Primary Completion

August 1, 2015

Study Completion

May 4, 2018

Last Updated

October 28, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)