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

NCT01835093 | Completed Phase 2

• 1 other identifier: G24061
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Outcome Measures

Primary Outcomes (1)

• ADHD Rating Scale-IV (ADHD-RS) Japanese Version

  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).

  Changes from baseline in ADHD-RS at 4-weeks

Secondary Outcomes (1)

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

  Change from baseline in the scores of battery at 4-weeks

Study Arms (1)

A single-arm study

EXPERIMENTAL

Drug: Tipepidine Hibenzate

Interventions

Tipepidine Hibenzate DRUG

A single-arm study

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiba University: lead

Study Sites (1)

Department of Psychiatry, Chiba University School of Medicine

Chiba, Chuo-ku, 260-8670, Japan

Location

Related Publications (1)

• Sasaki T, Hashimoto K, Tachibana M, Kurata T, Okawada K, Ishikawa M, Kimura H, Komatsu H, Ishikawa M, Hasegawa T, Shiina A, Hashimoto T, Kanahara N, Shiraishi T, Iyo M. Tipepidine in children with attention deficit/hyperactivity disorder: a 4-week, open-label, preliminary study. Neuropsychiatr Dis Treat. 2014 Jan 24;10:147-51. doi: 10.2147/NDT.S58480. eCollection 2014.

  PMID: 24493927 RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

tipepidine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Masaomi Iyo, MD,PhD

  Chairman, Department of Psychiatry, Chiba University Graduate School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: April 18, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: February 21, 2014

Record last verified: 2014-02

Locations

JP (1)