QPS study for treatment-resistant depression

JRCT ID: jRCTs032210317

Registered date:16/09/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Major Depressive Disorder
• Date of first enrollment: 16/09/2021
• Target sample size: 56
• Study type: Interventional

Intervention(s)

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 once a day for a total of 10 times over about 2 weeks.
The intervention is randomly assigned to the real stimulation group and the placebo stimulation group based on age, sex, and severity of depression.

Outcome(s)

• Primary Outcome: Total score changes in the Montgomery Asberg Depression Rating Scale (MADRS) from the baseline.

Secondary Outcome

<Clinical evaluations>
- 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)
<Cognitive evaluations>
- 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)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Mimura Masaru
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development