UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053124 |
|---|---|
| Receipt number | R000060624 |
| Scientific Title | The study on predicting recurrence of first-onset major depressive disorder using resting-state functional MRI |
| Date of disclosure of the study information | 2023/12/18 |
| Last modified on | 2023/12/15 23:46:16 |
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Basic information
Public title
The study on predicting recurrence of first-onset major depressive disorder using resting-state functional MRI
Acronym
The study on Predicting REcurrence of first-onset major DEpressive disorder using Resting-state functional MRI (PREDERM study)
Scientific Title
The study on predicting recurrence of first-onset major depressive disorder using resting-state functional MRI
Scientific Title:Acronym
The study on Predicting REcurrence of first-onset major DEpressive disorder using Resting-state functional MRI (PREDERM study)
Region
| Japan |
Condition
Condition
Major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Major depression disorder (MDD) is known as a mental illness with frequent recurrence. The lifetime recurrence rate after symptom remission is approximately 60% in newly diagnosed MDD, and the recurrence rate increases with repeated depressive episodes. Multiple episodes and psychotic features have been reported as risk factors for recurrence, but it has been pointed out that these reports lack consistency.
The purpose of this study is to examine whether functional connectivity obtained by resting state functional MRI after antidepressant discontinuation predicts recurrence in newly diagnosed MDD in remission.
Basic objectives2
Others
Basic objectives -Others
Evaluation of differences in brain networks using rsfMRI in depression remission maintenance group and depression relapse group
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
recurrence of MDD
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(Whole)
1. Each participant must have a level of understanding sufficient to agree to all tests including functional MRI and examinations required by the protocol and must sign an informed consent document.
2. right handed.
(Patients with MDD)
1. Participants must fulfill ICD-10 criteria for F32.
2. Currently in remission, defined as a HAM-D 17 score < 7 in 8 weeks or more.
(Healthy control)
1. No current or past psychiatric disorders.
2. HAM-D 17 score < 7.
Key exclusion criteria
(Patients with major depression)
1. Patients with any clinically significant psychiatric disorder other than ICD-10 criteria for F32.
2. Patients with any organic brain disease.
3. Patients with unstable medical illness.
(Healthy control)
Those who have a history of treatment for mood disorder or psychotic disorder in the third degree relative.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Nakamura |
Organization
Kurume university school of medicine
Division name
Neuropsychiatry
Zip code
8300011
Address
67 Asahimachi, Kurume city, Fukuoka, Japan.
TEL
+81-942-31-7613
nakamura_tomoyuki@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Nakamura |
Organization
Kurume university school of medicine
Division name
Neuropsychiatry
Zip code
8300011
Address
67 Asahimachi, Kurume city, Fukuoka, Japan
TEL
+81-942-31-7613
Homepage URL
nakamura_tomoyuki@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Kurume university school of medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurume University Medical Ethics Committee
Address
67 Asahimachi, Kurume city, Fukuoka, Japan.
Tel
0942-31-7200
kcrc_jimu@kurume-u.ac.jp
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
| 2023 | Year | 12 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to examine whether functional connectivity obtained by resting state functional MRI after antidepressant discontinuation predicts recurrence in newly diagnosed MDD in remission.
Management information
Registered date
| 2023 | Year | 12 | Month | 15 | Day |
Last modified on
| 2023 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060624
