Accelerated intermittent Theta Burst Stimulation (aiTBS) in bipolar disorder and schizophrenia

Accelerated intermittent Theta Burst Stimulation (aiTBS) in bipolar disorder and schizophrenia - aiTBS in bipolar disorder and schizophrenia

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53634

Enrollment

Registered

2023-04-28

Start date

2023-07-14

Completion date

Unknown

Last updated

2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar disorder and schizophrenia

Interventions

aiTBS according to aiTBS-5d-8s-50i protocol (5 consecutive days, 8 daily session, 10 minutes of stimulation with 50 minute interval).

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - 18-65 years - Ability to freely written informed consent - DSM-5 diagnosis of current depressive episode in bipolar I or II disorder OR DSM-5 diagnosis of schizophrenia - Therapy resistanve in bipolar disorder - HDRS>16 in bipolar depression at start study - SANS>3 on each item in schziphrenia - Stable medication (antidepressants or antipsychotics) at least 4 weeks prior start study.

Exclusion criteria

Exclusion criteria: * In BPD, (hypo) manic episode within 3 months prior start of the trial; * In BPD, Young Mania Rating Scale (YMRS) score of >12 prior start of the trial; * Patients with bipolar II disorder who use anti-depressant medication without anti-manic medication or patients with bipolar I disorder, not using anti-manic medication; * Acute suicidality; * (History of) neurological disease * (History of) epilepsy or epilepsy in a 1st degree relative; * Pregnancy; * Disorder in substance abuse * Known serious somatic health problem; * Used recreational drugs over a period of 72 hours prior each session; * Used alcohol within the last 24 hours prior each session; * Specific TMS contraindications (see standard screening form, appendix 1): ICD, pacemaker, history of epileptic seizures of epilepsy in a 1st degree relative, intracranial metal implants(e.g. cochlear implant or deep brain stimulator).

Design outcomes

Primary

Measure	Time frame
Primary outcomes are response (defined by 50% reduction on the HDRS, QIDS-SR , PANSS, SANS and CDSS), remission (defined by HDRS	—

Secondary

Measure	Time frame
To assess Heart Rate Variability (HRV) as part of parasympatic activation through dlPFC stimulation. HRV is measured through electrocardiogram (ECG).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 1, 2026