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
Conditions
Interventions
Trade Name: Syntocinon?Spray
Product Name: Syntocinon?Spray
Product Code: 11.266
Pharmaceutical Form: Nasal spray
INN or Proposed INN: O
Sponsors
UNIVERSITÄTSMEDIZIN GÖTTINGEN, GEORG-AUGUST-UNIVERSITÄT,Klinik für Kinder- und Jugendpsychiatrie/Psychotherapie
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main aim of the study is to investigate if the administration of oxytocin (vs. placebo) facilitates the acquisition of social skills and potentiates the effect of social skill training in patients high-functioning autismus spectrum disorders. ; Secondary Objective: Furthermore we investigate, if the effect of social learning via Oxytocin will be manifest over time. 1. Influence of intranasal applied oxytocin on social interaction, social communication and empathy 2. Influence of intranasal applied oxytocin on mental state and quality of life. ; Primary end point(s): Primary efficacy endpoint: 1. Social interaction and communication behaviour, rated by the parents ; Timepoint(s) of evaluation of this end point: baseline assessment end of intervention follow-up 3 months follow-up 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoint(s): 1. Prosocial behaviour and peer related problems 2. Emotional empathy 3. Depression 4. Psychological distress 5. Quality of life ; Timepoint(s) of evaluation of this end point: baseline assessment end of intervention follow-up 3 months follow-up 6 months | — |
Countries
Germany
Contacts
Public ContactTanja Schad-Hansjosten
Klinik für Psychiatrie und Psychotherapie des Kindes- und Jugendalters am Zentralinstitut für Seelische Gesundheit
Outcome results
None listed