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Integrative precision neuromodulation therapy for psychiatric disorders

Integrative precision neuromodulation therapy for psychiatric disorders: an open-label, pilot, umbrella basket study - integrative Precision Neuromodulation Therapy: an Umbrella Basket study (iPNT-UB)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032210059
Enrollment
90
Registered
2021-04-27
Start date
2021-11-22
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

Depression, bipolar disorder, schizophrenia, obsessive-compulsive disorder Depression, bipolar disorder, schizophrenia, obsessive-compulsive disorder

Interventions

Transcranial Magnetic Stimulation (TMS), Theta Burst Stimulation (TBS), Electroconvulsive Therapy (ECT), or Magnetic Seisure Therapy (MST) For patients with MDD or BD in depressive episode: 1)Tran
2)Electroconvulsive therapy (ECT) will be administered with brief or ultra-brief pulse on the bilateral prefrontal or temporal lobes or right hemisphere according to the patient's condition, effica
3) Magnetic Seizure Therapy (MST) will be administered with 25-100Hz pulse on the bilateral prefrontal or vertex regions according to the patient's condition, efficacy and tolerability. For patien
2)MST will be administered with 25-100Hz pulse on the bilateral prefrontal or vertex regions according to the patient's condition, efficacy and tolerability. For patients with OCD: 1)TMS will be pe
D004561, D050781, D004565
Neuromodulation therapy, transcranial magnetic stimulation, theta burst stimulation, electroconvulsive therapy, magnetic seizure therapy

Sponsors

Daisuke Hayashi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
For patients with MDD and BD with depressive episode: 1)Change in the scores of Montgomery Asberg depression rating scale (MADRS) before and after the intervention in acute treatment period. For patients with SZ with severe cognitive impairment: 1)Changes in the scores of the BACS before and after the intervention in acute treatment period. For patients with SZ with psychosis: 1)Changes in the scores of the Positive and Negative Syndrome Scale (PANSS) before and after the intervention in acute treatment period. For patients with OCD: 1)Changes in the scores of the Yale Brown Obsessive Compulsive Scale (YBOCS) before and after the intervention in acute treatment period.

Secondary

MeasureTime frame
For patients with MDD and BD with depressive episode: 1)Change in the scores of MADRS, HAMD, BACS, TMT, Stroop, and Clinical global impressions (CGI) in acute treatment and observation periods; 2)Response and remission rates after the intervention 3)Relapse/recurrence rate in observation period and duration of time from the end of intervention to relapse/recurrence. For patients with SZ: 1)Change in the scores of BACS, TMT, Stroop, PANSS, and CGI in acute treatment and observation periods; 2)Response and non-response rates after the intervention 3)Response and non-response rates in observation period. For patients with OCD: 1)Change in the scores of YBOCS, BACS, TMT, Stroop, HAMD, and CGI in acute treatment and observation periods; 2)Response, partial response, and non-response rates after the intervention 3)Response, partial response, and non-response rates in observation period.

Contacts

Public ContactMatsuo Junko

National Center of Neurology and Psychiatry Hospital

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

Outcome results

None listed

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