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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003281
Receipt No. R000003974
Scientific Title A Double-Blind, Randomized Study of Minocycline for the Decision-Making Process in Adult Healthy Volunteer
Date of disclosure of the study information 2010/03/05
Last modified on 2011/06/29

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Basic information
Public title A Double-Blind, Randomized Study of Minocycline for the Decision-Making Process in Adult Healthy Volunteer
Acronym A Double-Blind, Randomized Study of Minocycline for the Decision-Making Process in Adult Healthy Volunteer
Scientific Title A Double-Blind, Randomized Study of Minocycline for the Decision-Making Process in Adult Healthy Volunteer
Scientific Title:Acronym A Double-Blind, Randomized Study of Minocycline for the Decision-Making Process in Adult Healthy Volunteer
Region
Japan

Condition
Condition Healthy adult male
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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

Assessment
Primary outcomes Trust Game, Ultimatum game
Key secondary outcomes Self reported questionnaires including Trist, fairness and anxiety 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 inernally (every morning and evening for 4 days)
Interventions/Control_2 placebo drug's capsule internally (every morning and evening for 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
39 years-old >=
Gender Male
Key inclusion criteria 1. Healthy adult male
2. 20 years old to 39 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 60

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
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro 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
Email takahiro@npsych.med.kyushu-u.ac.jp

Sponsor
Institute Department of Neuropsychiatry, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization JSPS
Self funding
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Waseda University
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 九州大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 05 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
The minocycline group showed a strong and positive correlation between their degree of risk-taking and their evaluation scores of others' trustworthiness by a questionnaire, but the placebo group did not. 
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 02 Month 10 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2010 Year 04 Month 01 Day
Date of closure to data entry
2010 Year 05 Month 01 Day
Date trial data considered complete
2010 Year 05 Month 01 Day
Date analysis concluded
2010 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 03 Month 02 Day
Last modified on
2011 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003974

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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