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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
Sponsor:
Information provided by (Responsible Party):
Tsuyoshi Sasaki, Chiba University

Study Description
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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 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.

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

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 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Subscores (Inattentive subscore, Hyperactive/impulsive subscore) of the ADHD-RS-IV-J by physician. [ Time Frame: Changes from baseline in at 4-weeks ]
  2. 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 ]
  3. 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.

  4. Scores of CGI-ADHD-S, CGI-ADHD-I [ Time Frame: Changes from baseline in at 4-weeks ]
  5. Biologocal markers (Serum levels of Pro-BDNF, Mature-BDNF, Oxytocin) [ Time Frame: Changes from baseline in at 4-weeks ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

[Inclusion Criteria]

  1. Diagnosis of attention deficit hyperactivity disorder besed on DSM-5 criteria.
  2. Scores of 20 or higher in ADHD-RS (physician evaluation) total score.
  3. currently is an outpatient at Chiba University Hospital Department of Psychiatry or Child Psychiatry.
  4. currently receiving no medications for ADHD (atomoxetine, methylphenidate) treatment for the previous 4 weeks prior to enrollment in this study.
  5. currently receiving no medications of antidepressants, mood stabilizers and the antipsychotics treatment for the previous 4 weeks prior to enrollment in this study.
  6. currently receiving no medications of GIRK channel antagonist (tipepidine, cloperastine, caramiphen) treatment for the previous 4 weeks prior to enrollment in this study.
  7. Ages 6 - 17, male or female
  8. Provision of written informed consent by patients and parents or guardian.
  9. must be able to swallow capsuled medicine.

[Exclusion Criteria]

  1. History of allergic reaction or hypersensitivity to tipepidine hibenzate.
  2. Patients who have not been informed of having the disease at the time of informed consent.
  3. 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.
  4. currently receiving medications for ADHD (atomoxetine, methylphenidate) treatment for the previous 4 weeks prior to enrollment in this study.
  5. currently receiving medications of antidepressants, mood stabilizers and the antipsychotics treatment for the previous 4 weeks prior to enrollment in this study.
  6. currently receiving medications of GIRK channel antagonist (tipepidine, cloperastine, caramiphen) treatment for the previous 4 weeks prior to enrollment in this study.
  7. Somatic disorder which requires severe body management or severe meal management.
  8. participating in another clinical trial within 3 months prior to enrollment into this study. (except for observation study without intervention).
  9. planning change of treatment because of unstable neurological manifestations or somatic symptoms.
  10. History of suicidal ideation within the past year.
  11. pregnant or nursing, or intending to become pregnant or to start breastfeeding during the study.
  12. Other clinically significant reasons for exclusion by investigators.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Japan
Department of Psychiatry, Chiba University School of Medicine
Chiba, Chuo-ku, Japan, 260-8670
Sponsors and Collaborators
Chiba University
More Information
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Responsible Party: Tsuyoshi Sasaki, Department of Child Psychiatry, Chiba-University Hospital, Chiba University
ClinicalTrials.gov Identifier: NCT02305134    
Other Study ID Numbers: G26023
UMIN000015748 ( Other Identifier: UMIN Clinical Trials Registry (UMIN-CTR) )
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Keywords provided by Tsuyoshi Sasaki, Chiba University:
Tipepidine, GIRK
Additional relevant MeSH terms:
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Hyperkinesis
Disease
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Problem Behavior
Attention Deficit and Disruptive Behavior Disorders
 Pathologic Processes
Neurodevelopmental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Behavioral Symptoms