UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006552 |
|---|---|
| Receipt number | 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 08:20:08 |
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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)
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
mcn41320@biglobe.ne.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007765
