Attention-Deficit/Hyperactivity Disorder
Conditions
Interventions
Duration:8weeks Tropisetron hydrochloride (Navoban Capsules) 10mg/day Once-daily dosing
Duration:8weeks Placebo Once-daily dosing
Sponsors
Department of Psychiatry, Chiba University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet DSM-IV-TR criteria for current ADHD as well as criteria for a historical diagnosis of ADHD during childhood, both assessed by the CAADID at Visit 1. Patients must have a score of >=2 on at least 6 items of either the inattentive or hyperactive/impulsive core subscales at Visit 1 and 2 on the rated CAARS-Inv:SV 18-item total ADHD symptom score. In addition, their total score on the 18-item total ADHD symptom score (the sum of the inattention and hyperactivity/impulsivity subscales) must be >=20. Patients must have a CGI-ADHD-S score of 4 (moderate symptoms) or greater at Vists 1 and 2.
Exclusion criteria
Exclusion criteria: 1.Patients who have used nicotine preparations within 3 months of Visit 1. 2.Patients with serious physical disease or with organic brain desease; for example, dementia or seizure disorder. 3.Patients who meet full DSM-IV-TR diagnostic criteria for any history of major depression, any history of bipolar disorder, any history of schizophrenia and other psychotic disorders, or any history of obsessive-compulsive disorder. 4.Patients with depressive disorder who also have a total score of >=12 on the HAMD-17. 5.Patients who are at serious suicidal risk, or whose score for Item 11 on the HAMD-17 is equal or more than 2. 6.Patients who have been diagnosed (DSM-IV-TR) with a pervasive developmental disorder or a mental retardation. 7.Patients who have met DSM-IV-TR criteria for alcohol or other substance dependence within 3 months of Visit 1. 8.Female patients who are pregnant or nursing. 9.Patients who, in the opinion of the investigator, are unsuitable in any other way to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conners' Adult Attention Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) 18-item total ADHD symptom score The mean change from base-line to 8 weeks endpoint | — |
Secondary
| Measure | Time frame |
|---|---|
| Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report: Screening Version(CAARS-S:SV) Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Improvement(CGI-ADHD-I) Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity(CGI-ADHD-S) Adult ADHD Quality of Life Measure(AAQoL) P50 auditory evoked potential Cognition(CogState) Biological marker(BDNF etc.) | — |
Countries
Japan
Contacts
Public ContactTomihisa Niitsu
Chiba University Graduate School of Medicine Department of Psychiatry
Outcome results
None listed