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

Chiba University

Status and phase: Completed; Phase 2

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Drug: Tipepidine Hibenzate

Study type: Interventional

Funder types: Other

Identifiers

NCT01835093

G24061

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

[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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

A single-arm study

Experimental group

Treatment:

Drug: Tipepidine Hibenzate