UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003833 |
|---|---|
| Receipt number | R000004621 |
| Scientific Title | Chronobiological aspects of fear extinction by d-cycloserine and valproic acid |
| Date of disclosure of the study information | 2010/07/01 |
| Last modified on | 2012/04/10 14:38:18 |
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Basic information
Public title
Chronobiological aspects of fear extinction by d-cycloserine and valproic acid
Acronym
Chronobiological aspects of fear extinction by d-cycloserine and valproic acid
Scientific Title
Chronobiological aspects of fear extinction by d-cycloserine and valproic acid
Scientific Title:Acronym
Chronobiological aspects of fear extinction by d-cycloserine and valproic acid
Region
| Japan |
Condition
Condition
Anxiety disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether d-cycloserine and valproic acid accelerates the effect of fear extinction during night of sleep or not.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Skin conductance response
Key secondary outcomes
Task performances (Accuracy, response time)
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
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
placebo (sugar lactate (SL)) 500mg/ morning-evening schedule
Interventions/Control_2
placebo (sugar lactate (SL)) 500mg/ evening-morning schedule
Interventions/Control_3
d-cycloserine 100mg + SL 400mg/ morning-evening schedule
Interventions/Control_4
d-cycloserine 100mg + SL 400mg/ evening-morning schedule
Interventions/Control_5
Valproic acid 400mg + SL 100mg/ morning-evening schedule
Interventions/Control_6
Valproic acid 400mg + SL 100mg/ evening-morning schedule
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 subjects who had no history of drug or alcohol abuse or of neurological, psychiatric, or sleep disorders, and were maintaining a constant sleep schedule
Key exclusion criteria
Healthy subjects who had one or more histories of drug or alcohol abuse or of neurological, psychiatric, or sleep disorders, and/or were not maintaining a constant sleep schedule
Target sample size
90
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
Department of 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 | Kenichi Kuriyama |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Adult Mental Health
Zip code
Address
Kodaira, Tokyo 187-8502, Japan
TEL
042-346-1986
Homepage URL
kenichik@ncnp.go.jp
Sponsor or person
Institute
Department of Adult Mental Health, National Institute of Mental Health, National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Japan Scieence and Technology Agency
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
(独)国立精神・神経医療研究センター 精神保健研究所 成人精神保健研究部
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 01 | 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
| 2010 | Year | 05 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | 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 | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 28 | Day |
Last modified on
| 2012 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004621
