group-therapy, autism and oxytocin - an investigation with the question Does oxytocin (OT) enhance therapy effects in autism?

Phase 1

• Conditions: high-functioning autismus spectrum disorders: autistic disorder (F84.0), Asperger syndrome (F84.5), atypical autism (F84.1); MedDRA version: 20.0 Level: LLT Classification code 10021737 Term: Infantile autism System Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2010-024202-34-DE
• Lead Sponsor: IVERSITÄTSMEDIZIN GÖTTINGEN, GEORG-AUGUST-UNIVERSITÄT,Klinik für Kinder- und Jugendpsychiatrie/Psychotherapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-09
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 210

Inclusion Criteria

Diagnosis of autistic disorder (F84.0 according to ICD-10), Asperger syndrome (F84.5 according to ICD-10), atypical autism (F84.1 according to ICD-10)
male patients
Age 8-18 years
German as native language
no or stable psychopharmacotherapy
signed form of consent (for underage person: legal guardian)

Are the trial subjects under 18? yes
Number of subjects for this age range: 210
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 21
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Female
IQ < 80
traumatic lesions of the brain
obsessive-compulsive disorder
social anxiety disorder
major depression episode with suicidal ideation
aggressive behaviour interfering with group therapy
any personality disorder
serious neurological disease (e.g. epilepsy)
other medical disorder interfering with therapy
group based Social skill training during the last 6 months prior to study
cardiovascular disease
anamnestic known metabolic or endocrinologic disorders
anamnestic known hypersensitivity to nasal sprays or other drugs
within the 2 hours before the application of oxytocin/placebo intake of food, coffee, beverages (except water), nicotin-consumption as well as excessive fluid intake
hypersensitivity to oxytocin
(Safety: At the beginning of the study, each participant will receive OXT/Placebo while being monitored for 90 min by a physician. Participants experiencing serious adverse side effects will be excluded from the study. A trained physician will monitor each group-session)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified