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

* 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

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 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


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

Value
https://center6.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