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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001973
Receipt No. 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

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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
Email

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
Email kenichik@ncnp.go.jp

Sponsor
Institute National Institute of Mental Health, National Center of Neurology and Psychiatry
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002408

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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