Status:
COMPLETED
Tipepidine in Children With Attention Deficit/Hyperactivity Disorder (AD/HD): a Double-blind, Placebo-controlled Trial
Lead Sponsor:
Chiba University
Conditions:
Attention Deficit Disorder With Hyperactivity Disease
Hyperkinesis
Eligibility:
All Genders
6-17 years
Phase:
PHASE1
PHASE2
Brief Summary
Tipepidine (3-\[di-2-thienylmethylene\]-1-methylpiperidine) has been used solely as a nonnarcotic antitussive in Japan since 1959. The safety of tipepidine in children and adults has already been esta...
Detailed Description
Tipepidine (3-\[di-2-thienylmethylene\]-1-methylpiperidine) has been used solely as a nonnarcotic antitussive in Japan since 1959. The safety of tipepidine in children and adults has already been esta...
Eligibility Criteria
Inclusion
- \[Inclusion Criteria\]
- Diagnosis of attention deficit hyperactivity disorder besed on DSM-5 criteria.
- Scores of 20 or higher in ADHD-RS (physician evaluation) total score.
- currently is an outpatient at Chiba University Hospital Department of Psychiatry or Child Psychiatry.
- currently receiving no medications for ADHD (atomoxetine, methylphenidate) treatment for the previous 4 weeks prior to enrollment in this study.
- currently receiving no medications of antidepressants, mood stabilizers and the antipsychotics treatment for the previous 4 weeks prior to enrollment in this study.
- currently receiving no medications of GIRK channel antagonist (tipepidine, cloperastine, caramiphen) treatment for the previous 4 weeks prior to enrollment in this study.
- Ages 6 - 17, male or female
- Provision of written informed consent by patients and parents or guardian.
- must be able to swallow capsuled medicine.
- \[Exclusion Criteria\]
- History of allergic reaction or hypersensitivity to tipepidine hibenzate.
- Patients who have not been informed of having the disease at the time of informed consent.
- Diagnosis of any of the following diseases based on the DSM-5 criteria. Autism Spectrum Disorder, Schizophrenia Spectrum and Other Psychotic Disorders, Neurocognitive Disorders, Substance Related and Addictive Disorders, Feeding and Eating Disorders, Personality Disorders, Paraphilic Disorders.
- currently receiving medications for ADHD (atomoxetine, methylphenidate) treatment for the previous 4 weeks prior to enrollment in this study.
- currently receiving medications of antidepressants, mood stabilizers and the antipsychotics treatment for the previous 4 weeks prior to enrollment in this study.
- currently receiving medications of GIRK channel antagonist (tipepidine, cloperastine, caramiphen) treatment for the previous 4 weeks prior to enrollment in this study.
- Somatic disorder which requires severe body management or severe meal management.
- participating in another clinical trial within 3 months prior to enrollment into this study. (except for observation study without intervention).
- planning change of treatment because of unstable neurological manifestations or somatic symptoms.
- History of suicidal ideation within the past year.
- pregnant or nursing, or intending to become pregnant or to start breastfeeding during the study.
- Other clinically significant reasons for exclusion by investigators.
Exclusion
Key Trial Info
Start Date :
June 11 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT02305134
Start Date
June 11 2015
End Date
March 1 2019
Last Update
March 19 2019
Active Locations (1)
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1
Department of Psychiatry, Chiba University School of Medicine
Chiba, Chuo-ku, Japan, 260-8670