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

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

Tipepidine for ADHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01835093
• Other study ID #: G24061
• Status: Completed
• Phase: Phase 2
• First received: April 16, 2013
• Last updated: February 19, 2014
• Start date: April 2013
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Chiba University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

[Inclusion Criteria]

1. Attention-Deficit/Hyperactivity Disorder (AD/HD) for DSM-IV TR criteria.

2. Patients are treated with Atomoxetine, Methylphenidate, atypical antipsychotic drugs (risperidone, olanzapine, quetiapine, perospirone, aripiprazole, blonanserin, paliperidone) or not treated.

3. Patients are stable for 4-weeks for medication.

[Exclusion Criteria]

1. Patients with a previous hypersensitivity to Tipepidine Hibenzate.

2. Patients treated with typical antipsychotics and selective norepinephrine reuptake inhibitor (NRI) except atomoxetine and stimulants except methylphenidate.

3. Pregnant or breast-feeding women

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Drug:
• Tipepidine Hibenzate

Locations

Country	Name	City	State
Japan	Department of Psychiatry, Chiba University School of Medicine	Chiba	Chuo-ku

Sponsors (1)

Lead Sponsor	Collaborator
Chiba University

Country where clinical trial is conducted

Japan, 

References & 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-l — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Cognition using DN-CAS (Das-Naglieri Cognitive Assessment System) Japanese Version	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.	Change from baseline in the scores of battery at 4-weeks	Yes