Integrative precision neuromodulation therapy for psychiatric disorders

JRCT ID: jRCTs032210059

Registered date:27/04/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Depression, bipolar disorder, schizophrenia, obsessive-compulsive disorder
• Date of first enrollment: 22/11/2021
• Target sample size: 90
• Study type: Interventional

Intervention(s)

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)Transcranial magnetic stimulation (TMS) will be
performed 5 days a week up to 8 weeks with high
frequency (10-20Hz) or low frequency (1Hz)
repetitive TMS (rTMS) or with theta burst
stimulation (TBS) on the dorsolateral prefrontal
cortex (DLPFC);
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, efficacy and tolerability;
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 patients with SZ with cognitive impairment:
1)TMS will be performed 5 days a week up to
4 weeks with high frequency rTMS (5-20Hz) or
with TBS on the dorsolateral prefrontal cortex
(DLPFC).

For patients with SZ with psychosis:
1)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, efficacy and tolerability;
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 performed 5 days a week up to 6
weeks by rTMS (20Hz) on the dorsomedial
prefrontal cortex/anterior cingulate gyrus.

Outcome(s)

Primary Outcome

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 Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Daisuke Hayashi
• Secondary Sponsor: National Center of Neurology and Psychiatry
• Source(s) of Monetary Support: Nihon Medi-Physics Co., Ltd.,Japan Agency for Medical Research and Development,READYFOR Inc.