UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004803 |
|---|---|
| Receipt number | R000005719 |
| Scientific Title | A Double-Blind, Randomized Study of Minocycline for the Decision-Making Process in Young Adult Healthy Volunteer |
| Date of disclosure of the study information | 2010/12/29 |
| Last modified on | 2011/06/29 03:57:10 |
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Basic information
Public title
A Double-Blind, Randomized Study of Minocycline for the Decision-Making Process in Young Adult Healthy Volunteer
Acronym
A Double-Blind, Randomized Study of Minocycline for the Decision-Making Process in Young Adult Healthy Volunteer
Scientific Title
A Double-Blind, Randomized Study of Minocycline for the Decision-Making Process in Young Adult Healthy Volunteer
Scientific Title:Acronym
A Double-Blind, Randomized Study of Minocycline for the Decision-Making Process in Young Adult Healthy Volunteer
Region
| Japan |
Condition
Condition
Adult Males
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Minocycline is expected to be effective for psychiatric disorders by its brain protective effect. Interactions among brain protection, mental activity and social activity have not been well understood. Thus, we will conduct A Double-Blind, Randomized Study of Minocycline for the Decision-making process in Adult healthy volunteer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1: Trust game with an anonymous stranger
2: Trust games with 40 face pictures.
3: Task that subject try to detect cheaters in the past trust games
Key secondary outcomes
Self-reported questionnaire including
1 STAI, 2 TCI, and 3 General Trust scales.
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
100mg minocycline capsule, morning and evening, 4 days, controlled groups placebo drugs same dose and same days.
Interventions/Control_2
Placebo capsule, morning and evening, 4 days
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
| 29 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Healthy adult male
2.20 years old to 29 years old
3.Those who can obtain informed consent
Key exclusion criteria
1. Those who ever have side effects by antibiotics including minocycline
2. Those who have severe disease in heart, liver or kidney.
3. Those who have a tendency to develop allergy
4. Those who have ever diagnosed psychiatric disorders.
5. Those who are judged not appropriate to this study by medical doctor in charge.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigenobu Kanba, M.D., Ph.D. |
Organization
Kyushu University
Division name
Department of Neuropsychiatry, Graduate School of Medical Sciences
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka 812-8582 Japan
TEL
092-642-5627
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Takahiro A. Kato, M.D., Ph.A. Kato, M.D., Ph.D. |
Organization
Kyushu University
Division name
Department of Neuropsychiatry, Graduate School of Medical Sciences
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka 812-8582 Japan
TEL
-092-642-5627
Homepage URL
takahiro@npsych.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Waseda University
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
九州大学医系地区部局臨床研究倫理審査委員会
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 29 | 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
We found that some co-relationship between the score of trust game and some scores of TCI/STAI on minocycline-group.
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 | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 28 | Day |
Last modified on
| 2011 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005719
| 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 |
