Development of a diagnostic medical device program for mental disorders

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs032210197

Enrollment

300

Registered

2021-07-14

Start date

2021-10-07

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

Schizophrenia Schizophrenia

Interventions

Use a diagnostic medical device for healthy, schizophrenia and other mental disorders patients

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients diagnosed as healthy, schizophrenia and other mental disorders

Exclusion criteria

Exclusion criteria: Patients deemed inappropriate by Principal investigator

Design outcomes

Primary

Measure	Time frame
1.Area under ROC Curve in discriminating between healthy volunteers and schizophrenias	—

Secondary

Measure	Time frame
1.Sensitivity in discriminating patients with schizophrenia 2.Specificity at healthy volunteers 3.Specificity at other mental disorders patients 4.Percentage of correct classifications in discriminating between healthy volunteers and schizophrenias 5.Percentage of correct classifications in discriminating between other mental disorders and schizophrenias 6.Positive predictive value in discriminating between healthy volunteers and schizophrenias 7.Positive predictive value in discriminating between other mental disorders and schizophrenias 8.Correlation between the results of conventional eye movement tests and the results of eye movement tests using clinical trial equipment 9.Correlation between the results of conventional cognitive function tests and the results of cognitive function tests using clinical trial equipment 10.Correlation between clinical evaluation and eye movement test using clinical trial equipment 11.Correlation between clinical evaluation and cognitive function test using clinical trial equipment	—

Measure

Time frame

1.Sensitivity in discriminating patients with schizophrenia 2.Specificity at healthy volunteers 3.Specificity at other mental disorders patients 4.Percentage of correct classifications in discriminating between healthy volunteers and schizophrenias 5.Percentage of correct classifications in discriminating between other mental disorders and schizophrenias 6.Positive predictive value in discriminating between healthy volunteers and schizophrenias 7.Positive predictive value in discriminating between other mental disorders and schizophrenias 8.Correlation between the results of conventional eye movement tests and the results of eye movement tests using clinical trial equipment 9.Correlation between the results of conventional cognitive function tests and the results of cognitive function tests using clinical trial equipment 10.Correlation between clinical evaluation and eye movement test using clinical trial equipment 11.Correlation between clinical evaluation and cognitive function test using clinical trial equipment

—

Contacts

Public ContactTakami Ishizuka

National Center of Neurology and Psychiatry

ishizukatakami@ncnp.go.jp+81-42-341-2711

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026