Tipepidine in Children With Attention Deficit/Hyperactivity Disorder (AD/HD): a Double-blind, Placebo-controlled Trial
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|ClinicalTrials.gov Identifier: NCT02305134|
Recruitment Status : Completed
First Posted : December 2, 2014
Last Update Posted : March 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Disorder With Hyperactivity Disease Hyperkinesis Attention Deficit and Disruptive Behavior Disorders||Drug: Tipepidine Hibenzate Drug: Placebo||Phase 1 Phase 2|
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 established. It is reported that tipepidine inhibits G-protein-coupled inwardly rectifying potassium (GIRK)-channel currents. The inhibition of GIRK channels by tipepidine is expected to modulate the level of monoamines in the brain. We put forward the hypothesis that tipepidine can improve attention deficit/hyperactivity disorder (ADHD) symptoms by modulating monoaminergic neurotransmission through the inhibition of GIRK channels. The purpose of this double-blind, placebo-controlled trial is to confirm whether treatment with tipepidine can improve symptoms in pediatric patients with ADHD.
See our previous open trial, An Open Study of Tipepidine Hibenzate in Patients With Attention Deficit Hyperactivity Disorder (ADHD) http://clinicaltrials.gov/show/NCT01835093
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Tipepidine in Children With Attention Deficit/Hyperactivity Disorder (AD/HD): a Double-blind, Placebo-controlled Trial|
|Actual Study Start Date :||June 11, 2015|
|Actual Primary Completion Date :||March 2019|
|Actual Study Completion Date :||March 2019|
Active Comparator: Tipepidine Hibenzate
Tipepidine is taken orally at 30 mg/day (10 mg after breakfast, 10 mg after supper, and 10 mg before bedtime), for 4 weeks.
Drug: Tipepidine Hibenzate
Placebo Comparator: Placebo
Placebo is taken orally after breakfast, after supper, and before for 4 weeks.
- The ADHD Rating Scale IV Japanese Version (ADHD-RS-IV-J) by physician. [ Time Frame: Changes from baseline in ADHD-RS-IV-J at 4-weeks ]The ADHD Rating Scale-IV obtains parent ratings regarding the frequency of each ADHD symptom based on DSM-IV criteria. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items).
- Subscores (Inattentive subscore, Hyperactive/impulsive subscore) of the ADHD-RS-IV-J by physician. [ Time Frame: Changes from baseline in at 4-weeks ]
- Total scores and subscores (Inattentive subscore, Hyperactive/impulsive subscore) of the ADHD-RS-IV-J by parents. [ Time Frame: Changes from baseline in at 4-weeks ]
- Total scores and subscores (planning subscore, attention subscore, simultaneous subscore, successive subscore) of DN-CAS (Das-Naglieri Cognitive Assessment System) Japanese Version. [ Time Frame: Changes from baseline in at 4-weeks ]The DN-CAS is an assessment battery designed to evaluate cognitive processing. It was developed to integrate theoretical and applied areas of psychological knowledge using cognitive processing theory and tests designed to measure—Planning, Attention, Simultaneous, and Successive Processing (PASS)—in individuals ages 5-17. This assessment facilitates mental health professionals in the identification of Attention-Deficit/Hyperactivity Disorder, Traumatic Brain Injury, learning disabilities, Mental Retardation, and giftedness.
- Scores of CGI-ADHD-S, CGI-ADHD-I [ Time Frame: Changes from baseline in at 4-weeks ]
- Biologocal markers (Serum levels of Pro-BDNF, Mature-BDNF, Oxytocin) [ Time Frame: Changes from baseline in at 4-weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02305134
|Department of Psychiatry, Chiba University School of Medicine|
|Chiba, Chuo-ku, Japan, 260-8670|