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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003833
Receipt No. 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

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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
Email

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
Email kenichik@ncnp.go.jp

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

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
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 (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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004621

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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