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

NCT ID: NCT01835093

Last Updated: 2014-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-02-28

Brief Summary

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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

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Conditions

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Attention Deficit Disorder With Hyperactivity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A single-arm study

Group Type EXPERIMENTAL

Tipepidine Hibenzate

Intervention Type DRUG

Interventions

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Tipepidine Hibenzate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiba University

OTHER

Sponsor Role lead

Responsible Party

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Tsuyoshi Sasaki

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Masaomi Iyo, MD,PhD

Role: STUDY_CHAIR

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

Locations

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Department of Psychiatry, Chiba University School of Medicine

Chiba, Chuo-ku, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type RESULT
PMID: 24493927 (View on PubMed)

Other Identifiers

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G24061

Identifier Type: -

Identifier Source: org_study_id

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