UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006316 |
|---|---|
| Receipt number | R000007482 |
| Scientific Title | Bright light exposure effects on extinction learning of fear conditioning in human |
| Date of disclosure of the study information | 2011/09/08 |
| Last modified on | 2012/05/02 17:08:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Bright light exposure effects on extinction learning of fear conditioning in human
Acronym
Bright light exposure effects on fear extinction
Scientific Title
Bright light exposure effects on extinction learning of fear conditioning in human
Scientific Title:Acronym
Bright light exposure effects on fear extinction
Region
| Japan |
Condition
Condition
Anxiety disorder/ PTSD
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To examine whether exposure of bright light effect on fear conditioning extinction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Skin conductance response
Key secondary outcomes
Behaviour
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Bright light single exposure
Interventions/Control_2
low illumination single exposure
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy adults
Key exclusion criteria
retinal dystrophy/ age-related maculopathy/ hematoporphyria/ lupus erythematosus/ photosensitivity eruption/ chronic photosensitivity/ circadian rhythm sleep disorder/ shiftworker/ irregular worker/ recipient of antipsychotics, psoralen, anti-arrhythmics, antimalarials, antirheumatics or St. John's wort
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Kuriyama |
Organization
National Institute of Mental Health, National Center of Neurology and Psychiatry
Division name
Adult Mental Health
Zip code
Address
Kodaira, Tokyo 187-8502, Japan
TEL
042-346-1986
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Institute of Mental Health, National Center of Neurology and Psychiatry
Division name
Adult Mental Health
Zip code
Address
Kodaira, Tokyo 187-8502, Japan
TEL
Homepage URL
Sponsor or person
Institute
National Institute of Mental Health, National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
独）国立精神・神経医療研究センター 精神保健研究所 （東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | 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
Completed
Date of protocol fixation
| 2011 | Year | 07 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 08 | Day |
Last modified on
| 2012 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007482
