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

* 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

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 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


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

Value
https://center6.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