Tipepidine in children with attention deficit/hyperactivity disorder (AD/HD): a Double-blind, Placebo-controlled Trial
- Conditions
- Attention deficit/hyperactivity disorder (AD/HD)
- Registration Number
- JPRN-UMIN000015748
- Lead Sponsor
- Department of Psychiatry, Chiba University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
(1) History of allergic reaction or hypersensitivity to tipepidine hibenzate. (2) Patients who have not been informed of having the disease at the time of informed consent. (3) Diagnosis of any of the following diseases based on the DSM-5 criteria. Autism Spectrum Disorder, Schizophrenia Spectrum and Other Psychotic Disorders, Neurocognitive Disorders, Substance Related and Addictive Disorders, Feeding and Eating Disorders, Personality Disorders, Paraphilic Disorders. (4) currently receiving medications for ADHD (atomoxetine, methylphenidate) treatment for the previous 4 weeks prior to enrollment in this study. (5) currently receiving medications of antidepressants, mood stabilizers and the antipsychotics treatment for the previous 4 weeks prior to enrollment in this study. (6) currently receiving medications of GIRK channel antagonist (tipepidine, cloperastine, caramiphen) treatment for the previous 4 weeks prior to enrollment in this study. (7) Somatic disorder which requires severe body management or severe meal management. (8) participating in another clinical trial within 3 months prior to enrollment into this study. (except for observation study without intervention). (9) planning change of treatment because of unstable neurological manifestations or somatic symptoms. (10) History of suicidal ideation within the past year. (11) pregnant or nursing, or intending to become pregnant or to start breastfeeding during the study. (12) Other clinically significant reasons for exclusion by investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome Measure: The ADHD Rating Scale IV Japanese Version (ADHD-RS-IV-J) by physician. Time Frame: Changes from baseline in ADHD-RS-IV-J at 4-weeks
- Secondary Outcome Measures
Name Time Method Time Frame: Changes from baseline in at 4-weeks of 1-5. 1. Subscores (Inattentive subscore, Hyperactive/impulsive subscore) of the ADHD-RS-IV-J by physician. 2. Total scores and subscores (Inattentive subscore, Hyperactive/impulsive subscore) of the ADHD-RS-IV-J by parents. 3. Total scores and subscores (planning subscore, attention subscore, simultaneous subscore, successive subscore) of DN-CAS (Das-Naglieri Cognitive Assessment System) Japanese Version. 4. Scores of CGI-ADHD-S, CGI-ADHD-I 5. Biologocal markers (Serum levels of Pro-BDNF, Mature-BDNF, Oxytocin)