UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012019
Receipt number R000014045
Scientific Title Learning process in association with emotion in patients with mood disorders, using fear conditioning paradigm
Date of disclosure of the study information 2013/10/14
Last modified on 2017/04/13 09:18:48

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Basic information

Public title

Learning process in association with emotion in patients with mood disorders, using fear conditioning paradigm

Acronym

Learning process in association with emotion in patients with mood disorders, using fear conditioning paradigm

Scientific Title

Learning process in association with emotion in patients with mood disorders, using fear conditioning paradigm

Scientific Title:Acronym

Learning process in association with emotion in patients with mood disorders, using fear conditioning paradigm

Region

Japan


Condition

Condition

Mood disorders

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To elucidate learning process in association with emotional control in patients with mood disorders

Basic objectives2

Others

Basic objectives -Others

To characterize responses of patients with mood disorders to interpersonal stimuli

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Magnitude of the event-related skin conductance response

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Diagnosis

Type of intervention

Other

Interventions/Control_1

Patients with mood disorders will undergo the fear conditioning and extinction experiment.

Interventions/Control_2

Patients with schizophrenia will undergo the fear conditioning and extinction experiment.

Interventions/Control_3

Patients with neurotic disorders will undergo the fear conditioning and extinction experiment.

Interventions/Control_4

Healthy controls will undergo the fear conditioning and extinction experiment.

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

1) Diagnosis of mood disorders according to the ICD-10
2) 18 years or older of age
3) Female
4) Being capable to provide informed consent

(control group 1)
1) Diagnosis of schizophrenia, schizotypal and delusional disorders according to the ICD-10
2) 18 years or older of age
3) Female
4) Being capable to provide informed consent

(control group 2)
1) Diagnosis of neurotic, stress-related and somatoform disorders according to the ICD-10
2) 18 years or older of age
3) Female
4) Being capable to provide informed consent

(control group 3)
1) Individuals with no psychiatric disorder according to the ICD-10
2) 18 years or older of age
3) Female
4) Being capable to provide informed consent

Key exclusion criteria

1) Presence of any unstable physical or neurological disorder
2) Presence of severe depression (i.e. a score of >=4 in items of inner tension and/or pessimistic thoughts in the Montgomery-Asberg Depression Scale) or imminent suicidal thought (i.e. a score of >=4 in the item of suicidal thoughts in the MADRS)

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Uchida

Organization

Keio University School of Medicine

Division name

Department of Neuropsychiatry

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan

TEL

03-3353-1211(62454)

Email

hiroyuki.uchida.hu@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Hiroyuki Uchida

Organization

Keio University School of Medicine

Division name

Department of Neuropsychiatry

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan

TEL

03-3353-1211(62454)

Homepage URL


Email

hiroyuki.uchida.hu@gmail.com


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Neuropsychiatry, Keio University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

None


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

慶應義塾大学病院(東京都)


Other administrative information

Date of disclosure of the study information

2013 Year 10 Month 14 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

2013 Year 10 Month 04 Day

Date of IRB


Anticipated trial start date

2013 Year 10 Month 14 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 10 Month 11 Day

Last modified on

2017 Year 04 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014045


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name