Integrative precision neuromodulation therapy for psychiatric disorders

Phase 2

Recruiting

• Conditions: Depression, bipolar disorder, schizophrenia, obsessive-compulsive disorder; D003863, D001714, D012559, D009771

• Registration Number: JPRN-jRCTs032210059
• Lead Sponsor: Shinsuke Kito

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-27
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

For patients with major depressive disorder (MDD)
those who:
1)are diagnosed as MDD in depressive episode in
DSM-5;
2)are aged >=18;
3)got a total score of >=20 in HAMD-17; and
4)did not respond to pharmacotherapy
conducted as standard treatments
for patients with MDD.

For patients with bipolar disorder (BD), those who:
1)are diagnosed as BD in in depressive episode in
DSM-5;
2)are aged >=18;
3)got a total score of >=20 in HAMD-17; and
4)did not respond to pharmacotherapy
conducted as standard treatments
for patients with BD in depressive
episode.

For patients with schizophrenia (SZ), those who:
1)are diagnosed as SZ in DSM-5;
2)are aged >=18;
3)got a total score of >=60 in PANSS; and
4)did not respond to pharmacotherapy
conducted as standard treatments
for patients with SZ.

For patients with obsessive-compulsive disorder
(OCD),
those who:
1)are diagnosed as OCD in DSM-5;
2)are aged >=18;
3)got a total score of >=20 in YBOCS; and
4)did not respond to pharmacotherapy and/or
psychotherapy conducted as standard treatments
for patients with OCD.

Exclusion Criteria

1)patients who have concurrent mental disorders
such as autism spectrum disorder (ASD), attention
deficit hyperactive disorder (ADHD),
post-traumatic stress disorder (PTSD),
dissociative disorder, eating disorder,
substance-related disorder, and/or
personality disorder;
2)patients in pregnancy or lactating patients;
3)patients with a present or past history of
convulsive disorder (epilepsy, etc.) and their
first degree relatives with the same disorder;
4)patients with a present or past history of
neurological disorders or organic brain
disorders;
5)patients having magnetic substance which can
be hardly extracted such as a pacemaker, artificial
inner ear, and intracranial clip;
6)patients having physical disease such as severe
metabolic disease and endocrine disease;
7)patients with severe suicidal ideation; or
8)patients deemded inappropriate to participate
by judgement of principal investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified