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Clinical study of patients with major depressive disorder and healthy participants to examine the usefulness of the brain network marker program using fMRI for the diagnosis and stratification of major depressive disorder

Clinical study to examine the usefulness of the brain network marker program using fMRI for the diagnosis of major depressive disorder

Okada Go

Hiroshima University Hospital

1-2-3 Kasumi,Minami-ku,Hiroshima City,Hiroshima 734-8551,Japan

goookada@hiroshima-u.ac.jp

Okada Go

Hiroshima University

1-2-3 Kasumi,Minami-ku,Hiroshima City,Hiroshima 734-8551,Japan

+81-82-257-5814

goookada@hiroshima-u.ac.jp

Recruiting

Oct. 12, 2022

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

[Patients]
(1)Men and women aged between 20 and 75 at the time of consent acquisition.
(2)Patients with major depressive disorder using M.I.N.I. measured after obtaining the consent.
(3)Patients who provide written and voluntary consent for participation in this study.
[Healthy participants]
(1)Men and women aged between 20 and 75 at the time of consent acquisition.
(2)Those whose M.I.N.I. results measured after obtaining consent are not psychiatric disorders.
(3)Participants who provide written and voluntary consent for participation in this study.

[Patients]
(1)Patients with mental status that makes it difficult to understand the purpose of the study.
(2)Patients who meet any of the following criteria:
-Patients with depression with psychotic features.
-Patients who have been diagnosed with bipolar disorder or schizophrenia using DSM-5.
-Patients who have been diagnosed with substance abuse within 6 months prior to obtaining consent.
-Patients who have been treated for an anxiety disorder within 6 months prior to obtaining consent.
-Patient who have a comorbid personality disorder at the time of consent acquisition.
(3)Patients with significant suicidal tendencies.
(4)Patients with contraindications to MRI.
(5)Patients who are deemed inappropriate as research participants by the principal investigator or a subinvestigator.
[Healthy participants]
(1)Participants with current or history of psychiatric or neurological disorders.
(2)Participants with contraindications to MRI.
(3)Participants who are deemed inappropriate as research participants by the principal investigator or a subinvestigator.

Both

Patients with major depressive disorder and healthy participants.

For the escitalopram group, the study drug (Lexapro tablets or its generic products) will be used. We will conduct no pharmaceutical intervention in the usual care group, the cross-sectional study group, and the healthy participants group.

AUC of ROC curves in discriminating between depressed and healthy groups calculated using depression diagnostic brain network markers.

-Diagnostic brain network markers for major depressive disorder evaluated longitudinally (0w, 6w, 6m).
-Depression severity (Hamilton Rating Scale for Depression) obtained longitudinally (0w, 6w) in the escitalopram group.
-Depression severity (Hamilton Rating Scale for Depression) obtained longitudinally (0w, 6w) in the usual care group.

+81-82-257-1551

Aug. 10, 2022

Yes

The principal investigator, XNef, and ATR store the anonymized information obtained during the research period on a computer that is sufficiently secured with password management and the latest anti-virus measures. The information will be stored for five years from the date of the report of the research completion. After the storage period, the data will be disposed of appropriately while remaining anonymous. XNef will obtain consent for the possibility of long-term storage and use of the data for newly planned and conducted research and medical device development in the future.

none