UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007692 |
|---|---|
| Receipt number | R000009072 |
| Scientific Title | Open trial of papaverine for treatment-resistant schizophrenia |
| Date of disclosure of the study information | 2012/04/08 |
| Last modified on | 2013/07/14 05:42:25 |
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Basic information
Public title
Open trial of papaverine for treatment-resistant schizophrenia
Acronym
Papaverine Open Trial
Scientific Title
Open trial of papaverine for treatment-resistant schizophrenia
Scientific Title:Acronym
Papaverine Open Trial
Region
| Japan |
Condition
Condition
Treatment-resistant schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test whether additional administration of papaverine can be clinically useful for the patients with treatment-resistant schizophrenia.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Change of PANSS score.
Key secondary outcomes
Change of DIEPSS score.
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
Additional administration of papaverine.
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
Patients with Treatment-resistant schizophrenia.
Key exclusion criteria
Patients who are supposed to be in danger with papaverine.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaomi Iyo |
Organization
Chiba-university Hospital
Division name
Department of Psychiatry
Zip code
Address
1-8-1 Inohana, Chiba 260-8670, Japan
TEL
043-222-7171
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigenori Tadokoro |
Organization
Chiba-university Hospital
Division name
Department of Psychiatry
Zip code
Address
TEL
Homepage URL
tadokoroshigenori@gmail.com
Sponsor or person
Institute
Chiba-university Hospital
Institute
Department
Personal name
Funding Source
Organization
Chiba University Graduate School of Medicine, Chiba, Japan
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 08 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 08 | Day |
Last modified on
| 2013 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009072
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
