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

JRCT ID: jRCTs062220063

Registered date:12/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with major depressive disorder and healthy participants.
• Date of first enrollment: 24/10/2022
• Target sample size: 390
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

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

Secondary Outcome

-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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

[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.

Exclude 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-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.

Related Information

• Primary Sponsor: Okada Go
• Secondary Sponsor: XNef, Inc.
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development