UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006685 |
|---|---|
| Receipt number | R000007894 |
| Scientific Title | Effect of tandospirone on cognition and social function in schizophrenia |
| Date of disclosure of the study information | 2011/11/07 |
| Last modified on | 2011/11/30 15:45:10 |
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Basic information
Public title
Effect of tandospirone on cognition and social function in schizophrenia
Acronym
Cognition and tandospirone
Scientific Title
Effect of tandospirone on cognition and social function in schizophrenia
Scientific Title:Acronym
Cognition and tandospirone
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of tandospirone, a serotonin 5-HT1A partial agonist, on cognitive and social function in patients with schizophrenia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Schizophrenia Cognition Rating Scale (SCoRS)
Key secondary outcomes
UCSD Performance-based Skills Assessment-Brief (UPSA)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tandospirone added
Interventions/Control_2
Tandospirone not added
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
meets DSM-IV criteria for schizophrenia or schizoaffective disorder
good responder to antipsychotic treatment
PANSS score 70 or less
Provides written informed consent
Key exclusion criteria
1) Suicide attempt within 6 months before entry
2) Treated with a depot antipsychotic
3) Prescribed anticholinergic drugs and/or tricyclic antidepressants
4)Dependence on alcohol and/or illicit drugs
5) past history of head injury and/or seizure
6) IQ less than 75
7) pregnant
8) BACS and/or UPSA administered within past 6 months
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomiki Sumiyoshi |
Organization
University of Toyama
Division name
Department of Neuropsychiatry
Zip code
Address
2630 Sugitani, Toyama
TEL
076-434-7323
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Yamada |
Organization
University of Toyama
Division name
Department of Neuropsychiatry
Zip code
Address
2630 Sugitani, Toyama
TEL
076-434-7323
Homepage URL
tomikisumiyoshi840@hotmail.com
Sponsor or person
Institute
Department of Neuropsychiatry, University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Center of Neurology and Psychiatry
St Marianna Medical University
Kanazawa Medical University
Osaka University
Jikei Hospital
Okayama University
Hizen Psychiatric Center
Name of secondary funder(s)
N/A
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
富山大学附属病院（富山県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 07 | Day |
Related information
URL releasing protocol
http://www.med.u-toyama.ac.jp/neuropsychiatry/
Publication of results
Unpublished
Result
URL related to results and publications
http://www.med.u-toyama.ac.jp/neuropsychiatry/
Number of participants that the trial has enrolled
Results
N/A
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
Preinitiation
Date of protocol fixation
| 2011 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 01 | Day |
Other
Other related information
N/A
Management information
Registered date
| 2011 | Year | 11 | Month | 07 | Day |
Last modified on
| 2011 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007894
