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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006552
Receipt No. R000007765
Scientific Title Learning and memory reconsolidation update mechanism in humans with major depressive disorder
Date of disclosure of the study information 2011/11/01
Last modified on 2013/10/11

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Basic information
Public title Learning and memory reconsolidation update mechanism in humans with major depressive disorder
Acronym Reconsolidation update mechanism in humans with depression
Scientific Title Learning and memory reconsolidation update mechanism in humans with major depressive disorder
Scientific Title:Acronym Reconsolidation update mechanism in humans with depression
Region
Japan

Condition
Condition Major Depressive Disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the reconsolidation update mechanism of conditioned fear in patients with major depressive disorder, using skin conductance response
Basic objectives2 Others
Basic objectives -Others To compare the reconsolidation update mechanism between patients with major depressive disorder and healthy controls
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Skin Conductance Response upon the re-extinction task
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Behavior,custom
Interventions/Control_1 On the first day, patients with major depressive disorder will undergo the acquisition task. On the second day, they will receive reminder stimuli, and then extinction training will be performed in 10 minutes. On the third day, they will receive reinstatement task, and then re-extinction training will be performed in 10 minutes.
Interventions/Control_2 On the first day, healthy controls will undergo the acquisition task. On the second day, they will receive reminder stimuli, and then extinction training will be performed in 10 minutes. On the third day, they will receive reinstatement task, and then re-extinction training will be performed in 10 minutes.
Interventions/Control_3
Interventions/Control_4
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 Male
Key inclusion criteria 1) Diagnosis of major depressive disorder according to the DSM-IV
2) 18 years or older of age
3) Being capable to provide informed consent

(Healthy controls)
1) Individuals with no psychiatric disorder according to the DSM-IV
2) 18 years or older of age
3) Being capable to provide informed consent
Key exclusion criteria 1) Presence of any unstable physical or neurological disorder
2) Presence of clinical severe depression(>=4 in the item score for inner tension or pessimistic thoughts in the Montgomery-Asberg Depression Scale) or imminent suicidal thought(>=4 in the item score for suicidal thoughts in the MADRS)
Target sample size 40

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

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 mcn41320@biglobe.ne.jp

Sponsor
Institute Department of Neuropsychiatry, Keio University School of Medicine
Institute
Department

Funding Source
Organization None
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
2011 Year 11 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
2012 Year 10 Month 17 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 08 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 10 Month 17 Day
Last modified on
2013 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007765

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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