QPS study for treatment-resistant depressio

Phase 2

• Conditions: Treatment-Resistant Depression; Major Depressive Disorder

• Registration Number: JPRN-jRCTs032210317
• Lead Sponsor: Mimura Masaru

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-16
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 56

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

- 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total score changes in the Montgomery Asberg Depression Rating Scale (MADRS) from the baseline.

Secondary Outcome Measures

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