UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004702 |
|---|---|
| Receipt number | R000005546 |
| Scientific Title | A randomised, double-blind, placebo-controlled trial of tropisetron in adult patients with attention-deficit/hyperactivity disorder (ADHD) |
| Date of disclosure of the study information | 2010/12/12 |
| Last modified on | 2019/02/25 18:10:55 |
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Basic information
Public title
A randomised, double-blind, placebo-controlled trial of tropisetron in adult patients with attention-deficit/hyperactivity disorder (ADHD)
Acronym
Clinical trial of tropisetron in adult ADHD
Scientific Title
A randomised, double-blind, placebo-controlled trial of tropisetron in adult patients with attention-deficit/hyperactivity disorder (ADHD)
Scientific Title:Acronym
Clinical trial of tropisetron in adult ADHD
Region
| Japan |
Condition
Condition
Attention-Deficit/Hyperactivity Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of tropisetron in adult patients with attention-deficit/hyperactivity disorder.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
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
Key secondary outcomes
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.)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Duration:8weeks
Tropisetron hydrochloride (Navoban Capsules) 10mg/day
Once-daily dosing
Interventions/Control_2
Duration:8weeks
Placebo
Once-daily dosing
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaomi Iyo |
Organization
Chiba University Graduate School of Medicine
Division name
Psychiatry
Zip code
Address
1-8-1 Inohna, Chuo-ku, Chiba, Japan
TEL
043-226-2148
iyom@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomihisa Niitsu |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
Address
1-8-1 Inohna, Chuo-ku, Chiba, Japan
TEL
043-226-2148
Homepage URL
niitsu@chiba-u.jp
Sponsor or person
Institute
Department of Psychiatry, Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
千葉大学医学部附属病院(千葉県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 10 | Day |
Last modified on
| 2019 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005546
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