UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001973 |
|---|---|
| Receipt number | R000002408 |
| Scientific Title | Effects of d-cycloserine and valproic acid on extinction of fear conditioning or other lerning |
| Date of disclosure of the study information | 2009/05/15 |
| Last modified on | 2012/05/02 17:11:12 |
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Basic information
Public title
Effects of d-cycloserine and valproic acid on extinction of fear conditioning or other lerning
Acronym
Effects of d-cycloserine and valproic acid on learning
Scientific Title
Effects of d-cycloserine and valproic acid on extinction of fear conditioning or other lerning
Scientific Title:Acronym
Effects of d-cycloserine and valproic acid on learning
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will evaluate whether the drug D-cycloserine (DCS) and Valproic acid (VA) can improve a type of learning called fear conditioning, in which the brain learns to associate neutral stimuli with stimuli that elicit emotional or physiological responses.
Basic objectives2
Others
Basic objectives -Others
This study will also evaluate whether the drug D-cycloserine (DCS) and Valproic acid (VA) can improve another type of learning such as declarative, procedural and working memory.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Participants' physiological responses to the stimuli will be recorded. Electrodes will be placed on two fingers (to measure sweat, or electrodermal activity), on both wrists and a lower leg (to measure heart rate).
Key secondary outcomes
Accuracy and reaction time to tha memory tasks are also included as secondary ealuation outcomes.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
100mg D-cycloserine
Interventions/Control_2
400mg Valproic acid
Interventions/Control_3
100mg D-cycloserine with 400mg Valproic acid
Interventions/Control_4
placebo (inactive substance)
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers with informed consent
Key exclusion criteria
1. Having previous histories of drug or alcohol abuse or of neurological, psychiatric, or physiological disorders.
2. Taking an OTC [over-the-counter] drug and/or supplement tablets regularly.
3. Who recognized as unsuitable for testing by physician.
Target sample size
60
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
Departments of Adult Mental Health
Zip code
Address
4-1-1 Ogawahigashi, Kodaira, Tokyo 187-8553, Japan
TEL
042-346-1986
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Kuriyama |
Organization
National Institute of Mental Health, National Center of Neurology and Psychiatry
Division name
Departments of Adult Mental Health
Zip code
Address
4-1-1 Ogawahigashi, Kodaira, Tokyo 187-8553, Japan
TEL
042-346-1986
Homepage URL
kenichik@ncnp.go.jp
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
Organization
Division
Category of Funding Organization
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
| 2009 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2009 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 15 | 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=R000002408
