An Open Study of Tipepidine Hibenzate in Patients With Attention Deficit Hyperactivity Disorder (ADHD)

Phase 2

Completed

• Conditions: Attention Deficit Disorder With Hyperactivity
• Interventions: Drug: Tipepidine Hibenzate

• Registration Number: NCT01835093
• Lead Sponsor: Chiba University

Brief Summary

Accumulating evidence suggests a role of G protein-coupled inwardly-rectifying potassium (GIRK) channel in the pathology of excitement of nerve, and the medicine with the action (like the Tipepidine Hibenzate) is expected as a new curative medicine of Attention Deficit / Hyperactivity Disorder (AD/HD).

The purpose of this research is to confirm the effect by carrying out the additional dosage of the Tipepidine Hibenzate to the AD/HD patients.

If suggestion is obtained by this research about the effect on AD/HD of Tipepidine Hibenzate, it can contribute to development of the medical treatment of AD/HD.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-16
• Study First Submitted QC: 2013-04-16
• Study First Posted: 2013-04-18
• Primary Completion: 2013-12
• Status Verified: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-19
• Last Update Posted: 2014-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A single-arm study	Tipepidine Hibenzate	-

Primary Outcome Measures

Name	Time	Method
ADHD Rating Scale-IV (ADHD-RS) Japanese Version	Changes from baseline in ADHD-RS 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

Name	Time	Method
Cognition using DN-CAS (Das-Naglieri Cognitive Assessment System) Japanese Version	Change from baseline in the scores of battery 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.

Trial Locations

Locations (1)

Department of Psychiatry, Chiba University School of Medicine; 🇯🇵 Chiba, Chuo-ku, Japan