UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006398 |
|---|---|
| Receipt number | R000007595 |
| Scientific Title | Clinical pharmacological trial of TM8001 for schizophrenia associated with carbonyl stress |
| Date of disclosure of the study information | 2011/10/01 |
| Last modified on | 2011/09/23 12:20:31 |
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Basic information
Public title
Clinical pharmacological trial of TM8001 for schizophrenia associated with carbonyl stress
Acronym
Clinical pharmacological trial of TM8001 for schizophrenia associated with carbonyl stress
Scientific Title
Clinical pharmacological trial of TM8001 for schizophrenia associated with carbonyl stress
Scientific Title:Acronym
Clinical pharmacological trial of TM8001 for schizophrenia associated with carbonyl stress
Region
| Japan |
Condition
Condition
schizophrenia associated with carbonyl stress
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Exploratory trial to access safety and efficacy of TM8001 for schizophrenia associated with carbonyl stress
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
PANSS, BPRS
Key secondary outcomes
plasma pentosidine level
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
intervention taking TM8001
Interventions/Control_2
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
An inpatient over 20 years old or under 65 years of age.
A patients diagnosed as schizophrenia according to DSMIVTR before one year from consent.
A subjects with over 55.2ng/mL of plasma pentosidine.
A patients showing over 60 or under 120 of PANSS.
A patients with informed consent by own or representative family.
Key exclusion criteria
creatinin >2mg/dL or BUN > 25mg/dL.
HbA1c > 6.1% and fetal blood suger > 126mg/dL or blood suger > 200mg/dL.
AST, ALT over 2.5 fold of standard level.
Total bilirubin > 3mg/dL.
sever cardiac diseases, lung diseases, hepatic diseases, neurological diseases, hematological diseases, endocrine diseases,immune diseases, other sever diseases.
History of anaphylaxis shock, drug allergy.
History of taking aminophylline
, teophylline, cholinteophylline, levodopa within 4 weeks before trail.
History of taking ECT within 3 months before trail.
Possible risk of suicide.
History of cancer within 5 years before trail.
Participating other trial.
Pregnancy.
Inappropriate regarded by the responsible doctor.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanari Itokawa |
Organization
Tokyo Metropolitan Matsuzawa Hospital
Division name
Dep. of Psychiatry
Zip code
Address
2-1-1 Kamikitazawa, Setagaya-ku, Tokyo, Japan
TEL
81-3-3303-7211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromi Idozawa |
Organization
Tokyo Metropolitan Matsuzawa Hospital
Division name
Department of Medicine
Zip code
Address
2-1-1 Kamikitazawa, Setagaya-ku, Tokyo, Japan
TEL
81-3-3303-7211
Homepage URL
http://www.byouin.metro.tokyo.jp/matsuzawa/
chiken-psy@matsuzawa-hp.metro.tokyo.jp
Sponsor or person
Institute
Tokyo Metropolitan Matsuzawa Hospital
Institute
Department
Personal name
Funding Source
Organization
Project PM company
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 23 | Day |
Last modified on
| 2011 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007595
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
