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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003084
Receipt No. R000003742
Scientific Title Double-blind placebo controlled study of the adjunctive effect of tropisetron on cognitive deficits in schizophrenia
Date of disclosure of the study information 2010/01/25
Last modified on 2010/01/25

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Basic information
Public title Double-blind placebo controlled study of the adjunctive effect of tropisetron on cognitive deficits in schizophrenia
Acronym Double-blind placebo controlled study of the adjunctive effect of tropisetron on cognitive deficits in schizophrenia
Scientific Title Double-blind placebo controlled study of the adjunctive effect of tropisetron on cognitive deficits in schizophrenia
Scientific Title:Acronym Double-blind placebo controlled study of the adjunctive effect of tropisetron on cognitive deficits in schizophrenia
Region
Japan

Condition
Condition schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will study the effects of tropisetron on the cognitive deficits of schizophrenic patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes cognitive function of the patient at 4, and 8 weeks after starting
Key secondary outcomes mental status, quality of life, and so on of the patient at 4, and 8 weeks after starting

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 10mg of tropisetron daily during 8 weeks
Interventions/Control_2 placebo during 8 weeks
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
50 years-old >=
Gender Male and Female
Key inclusion criteria outpatient of Chiba University Hospital with schizophrenia meeting the DSM-IV-TR criteria taking risperidone (2-6 mg/day) for at least 8 weeks
Key exclusion criteria history of other neurologic illness, pregnant or suckling are excluded
Target sample size 40

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 Department of Psychiatry
Zip code
Address 1-8-1 Inohana, Chuoh-ku, Chiba-shi Chiba, Japan
TEL +81-43-226-2149
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akihiro Shiina
Organization Chiba University Hospital
Division name Department of Psychiatry
Zip code
Address 1-8-1 Inohana, Chuoh-ku, Chiba-shi Chiba, Japan
TEL +81-43-226-2297
Homepage URL
Email shiina-akihiro@faculty.chiba-u.jp

Sponsor
Institute Department of Psychiatry, Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization Stanly Research Foundation and the Program for Promotion of Fundamental Studies in Health Sciences of the National Institute of Biomedical Innovation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 25 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
2006 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date
2006 Year 06 Month 01 Day
Last follow-up date
2009 Year 04 Month 01 Day
Date of closure to data entry
2009 Year 04 Month 01 Day
Date trial data considered complete
2009 Year 04 Month 01 Day
Date analysis concluded
2010 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 01 Month 25 Day
Last modified on
2010 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003742

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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