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
- Conditions
- Patients with major depressive disorder and healthy participants
- Registration Number
- JPRN-UMIN000049967
- Lead Sponsor
- Tokyo Medical and Dental University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 520
Not provided
[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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC of ROC curves in discriminating between depressed and healthy groups calculated using depression diagnostic brain network markers
- Secondary Outcome Measures
Name Time Method -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.