Tipepidine in Children With Attention Deficit/Hyperactivity Disorder (AD/HD): a Double-blind, Placebo-controlled Trial

NCT ID: NCT02305134

Last Updated: 2019-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-11
• Study Completion Date: 2019-03-31

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.

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

Conditions

Attention Deficit Disorder With Hyperactivity Disease; Hyperkinesis; Attention Deficit and Disruptive Behavior Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Tipepidine Hibenzate

Intervention Type: DRUG

Placebo

Placebo is taken orally after breakfast, after supper, and before for 4 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Tipepidine Hibenzate

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiba University

OTHER

Sponsor Role: lead

Responsible Party

Tsuyoshi Sasaki

Department of Child Psychiatry, Chiba-University Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Psychiatry, Chiba University School of Medicine

Chiba, Chuo-ku, Japan

Countries

Japan

Other Identifiers

UMIN000015748

Identifier Type: OTHER

Identifier Source: secondary_id

G26023

Identifier Type: -

Identifier Source: org_study_id