Multi-institutional 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

Multi-institutional 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 - Multi-institutional clinical study to examine the usefulness of the brain network marker program using fMRI for the diagnosis of major depressive disorder

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000049967

Enrollment

520

Registered

2023-03-24

Start date

2023-06-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with major depressive disorder and healthy participants

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: [Patients] (1)Men and women aged between 20 and 75 at the time of consent acquisition. (2)Patients with major depressive disorder using structured diagnostic interview 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 psychiatric diagnostic interview results measured after obtaining consent are not psychiatric disorders. (3)Participants who provide written and voluntary consent for participation in this study.

Exclusion criteria

Exclusion criteria: [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. -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.

Design outcomes

Primary

Measure	Time frame
AUC of ROC curves in discriminating between depressed and healthy groups calculated using depression diagnostic brain network markers	—

Secondary

Measure	Time frame
-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 usual care group.	—

Countries

Japan

Contacts

Public ContactJunya Fujino

Institute of Science Tokyo Department of Psychiatry and Behavioral Sciences

jf15psyc@tmd.ac.jp03-5803-5238

Outcome results