QPS study for treatment-resistant depression

Development of next-generation neuromodulatory therapeutics by quadripulse transcranial magnetic stimulation for treatment-resistant depression and elucidation of its therapeutic mechanism - Next-generation neuromodulatory therapeutics by QPS for treatment-resistant depression

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs032210317

Enrollment

Registered

2021-09-16

Start date

2021-09-16

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

Major Depressive Disorder Treatment-Resistant Depression

Interventions

MRI neuro-navigation system is used to identify the optimal stimulation site in the prefrontal cortex for each subject, and quadripulse transcranial magnetic stimulation (QPS) protocol is performed on

quadripulse transcranial magnetic stimulation (QPS)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with treatment-resistant depression that meet the following conditions: - Person who is between 20 and 65 years old at the time of obtaining informed consent. - Those who meet the diagnostic criteria for depression in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). - Persons who have a severity of 18 or more on the score of MADRS. - Person who is able to obtain written consent.

Exclusion criteria

Exclusion criteria: - Patients who have cerebral organic diseases (intracranial organic lesions of moderate or higher grade, neurodegenerative diseases, etc.). - Patients with a history of seizures or epilepsy, serious or unstable physical illness. - Metal implants, pacemakers, people with contraindications for TMS or MRI such as claustrophobia.

Design outcomes

Primary

Measure	Time frame
Total score changes in the Montgomery Asberg Depression Rating Scale (MADRS) from the baseline.	—

Secondary

Measure	Time frame
- 21-item Hamilton Rating Scale for Depression (HRSD-21) - 16-item Quick Inventory of Depressive Symptoms-Japanese version (QIDS16-J) - Brief Symptom Inventory-anxiety subscale (BSI-anxiety) - Beck Suicide Scale for Suicide Ideation (BSS) - Pittsburgh Sleep Quality Index (PSQI) - Quality of Life Enjoyment and Satisfaction Scale (QLESQ) - Montreal Cognitive Assessment (MoCA) - Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) - Letter Number Sequencing Test (LNST) - Stroop Neuropsychological Screening Test (SNST) - Trail Making Test (TMT) - The Executive Interview (EXIT25)	—

Measure

Time frame

- 21-item Hamilton Rating Scale for Depression (HRSD-21) - 16-item Quick Inventory of Depressive Symptoms-Japanese version (QIDS16-J) - Brief Symptom Inventory-anxiety subscale (BSI-anxiety) - Beck Suicide Scale for Suicide Ideation (BSS) - Pittsburgh Sleep Quality Index (PSQI) - Quality of Life Enjoyment and Satisfaction Scale (QLESQ) - Montreal Cognitive Assessment (MoCA) - Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) - Letter Number Sequencing Test (LNST) - Stroop Neuropsychological Screening Test (SNST) - Trail Making Test (TMT) - The Executive Interview (EXIT25)

—

Contacts

Public ContactYoshihiro Noda

Keio University Hospital

yoshi-tms@keio.jp+81-3-3353-1211

Outcome results

None listed

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