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Tipepidine in children with Autism Spectrum Disorder : a 4-week, open-label, preliminary study

Tipepidine in children with Autism Spectrum Disorder : a 4-week, open-label, preliminary study - Tipepidine in children with Autism Spectrum Disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000028350
Enrollment
10
Registered
2017-07-24
Start date
2017-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Interventions

Tipepidine Hibenzate (30mg/day, 4weeks)

Sponsors

Chiba University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.diagnosis of ASD in accordance with the criteria in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) 2.Patients not being treated or taking atypical antipsychotics (risperidone, olanzapine, quetiapine, perospirone, aripiprazole, blonanserin, paliperidone), atomoxetine, methylphenidate, carbamazepine, sodium valproate, gabapentin, topiramate, lamotrigine are eligible 3.The dose of the concomitant drugs has been fixed for at least 4 weeks prior to entry 3.Patients are stable for 4-weeks for medication.

Exclusion criteria

Exclusion criteria: 1.Patients with a previous hypersensitivity to Tipepidine Hibenzate. 2.Patients treated with typical antipsychotics and selective norepinephrine reuptake inhibitor (NRI) except atomoxetine and stimulants except methylphenidate. 3.Pregnant or breast-feeding women

Design outcomes

Primary

MeasureTime frame
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [Time Frame: Changes from baseline in CY-BOCS at 4-weeks ]

Secondary

MeasureTime frame
Repetitive Behavior Scale-Revised(RBS-R), Clinical Global Impression of Change(CGI-C), Vineland Adaptive Behavior Scales Second Edition(Vineland-II) the level of plasma glutamic acid,pro-BDNF,mature-BDNF,MMP-9,oxytocin [Time Frame:Change between baseline scores and 4-weeks]

Countries

Japan

Contacts

Public ContactAyumi Okato

Chiba University Hospital Department of Child Psychiatry

okatoa@chiba-u.jp043-222-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026