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OpenTrials
Completed

NCT Number: NCT01835093

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

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.

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Psychiatry, Chiba University School of Medicine

Chiba, Chuo-ku, 260-8670, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

[Inclusion Criteria]

  • Attention-Deficit/Hyperactivity Disorder (AD/HD) for DSM-IV TR criteria.
  • Patients are treated with Atomoxetine, Methylphenidate, atypical antipsychotic drugs (risperidone, olanzapine, quetiapine, perospirone, aripiprazole, blonanserin, paliperidone) or not treated.
  • Patients are stable for 4-weeks for medication.

[Exclusion Criteria]

  • Patients with a previous hypersensitivity to Tipepidine Hibenzate.
  • Patients treated with typical antipsychotics and selective norepinephrine reuptake inhibitor (NRI) except atomoxetine and stimulants except methylphenidate.
  • Pregnant or breast-feeding women

Treatment and study plan

Tipepidine Hibenzate

Drug

Primary outcomes

  1. ADHD Rating Scale-IV (ADHD-RS) Japanese Version

    Time frame: 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 outcomes

  1. Cognition using DN-CAS (Das-Naglieri Cognitive Assessment System) Japanese Version

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chiba University

Other

Registry information

Official study title

Tipepidine for ADHD

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Apr 18, 2013
Registry last updated
Feb 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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