An interventional study of active rTMS: 20min inter-session interval and active rTMS: 50min inter-session interval in Moderate Depression, Major Depressive Disorder and Severe Depression, sponsored by Changping Laboratory. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-07-24.
Sponsored by Changping Laboratory · Not applicable, Interventional, and Treatment
The investigators aim to explore the efficacy and safety of rTMS therapies with different intervals between sessions for treating patients with moderate to severe depression.
FDA-approved intermittent theta burst stimulation (iTBS) for the treatment of depression disorder, reduces the duration of a single sequence treatment from 37 minutes to 3 minutes with traditional rTMS and gets the same antidepressant effect. Studies have shown that large doses and individualized target stimulation based on iTBS can improve the efficacy of rTMS and greatly save the time spent during patient treatment, but the effect of the interval between iTBS sessions on the efficacy is inconclusive. Previous studies on interval effect in rats based on iTBS have indirectly found that the waiting time between iTBS sessions of 50 to 90 minutes can maximize the cumulative effect of stimulation, so researchers mostly set the iTBS treatment interval to 50 minutes. However, most patients give up treatment because of the long wait time of 50 minutes, so it is urgent to explore the effect of short intervals of iTBS accepted easier by patients. In this study, we examined the intersession interval of 50 min vs. 20 min in the efficacy and safety of pBFS-guided TMS treatment in patients with moderate to severe depression.
After being informed about the study and potential risks. All patients giving written informed consent will undergo a screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner in a 4:4:1:1 ratio to a 50-minute active rTMS group, a 20-minute active rTMS group, a 50-minute sham-control group, and a 20-minute sham-control group. And then all participants will undergo a 21-day rTMS treatment followed by two-week and four-week follow-up visits.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 50 is below the median of 84 across 6,720 interventional studies indexed under Depression.
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Exclusion Criteria:
Three sessions of active rTMS would be delivered, with 1800 pulse/session and 20 min inter-session intervals.
Device: active rTMS: 20min inter-session interval
Three sessions of active rTMS would be delivered, with 1800 pulse/session and 50 min inter-session intervals.
Device: active rTMS: 50min inter-session interval
Three sessions of sham rTMS would be delivered, with 1800 pulse/session and 20 min inter-session intervals.
Device: sham rTMS: 20min inter-session interval
Three sessions of sham rTMS would be delivered, with 1800 pulse/session and 50 min inter-session intervals.
Device: sham rTMS: 50min inter-session interval
Participants will receive active TMS, with 3 sessions per day, 1800 pulses/session, and 20 min inter-session intervals, lasting for 21 days. Individualized targets will be generated using the pBFS method.
Participants will receive active TMS, with 3 sessions per day, 1800 pulses/session, and 50 min inter-session intervals, lasting for 21 days. Individualized targets will be generated using the pBFS method.
The parameters in this group are the same as in the active rTMS: 20min inter-session interval group. Stimulation was delivered by the same device as the active group fitted with a sham coil.
The parameters in this group are the same as in the active rTMS: 50min inter-session interval group. Stimulation was delivered by the same device as the active group fitted with a sham coil.
change in MADRS
A provider-administered questionnaire was used to assess remission and recovery from depression. The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The MADRS has an overall score range from 0-60, with higher scores corresponding to higher levels of depression
Time frame: Baseline and Day 21(immediate post-treatment)
change in MADRS
A provider-administered questionnaire was used to assess remission and recovery from depression. The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The MADRS has an overall score range from 0-60, with higher scores corresponding to higher levels of depression
Time frame: Baseline, Day 7, Day 14, Day 21, 2-week post-treatment, 4-week post-treatment
change in HAMD
A provider-administered questionnaire was used to assess remission and recovery from depression. The Hamilton Depression Rating Scale (HAMD) is the most widely used clinician-administered depression assessment scale. The Ham-17 version consists of 17 items assessing mood, guilt, general somatic symptoms, work and activities, anxiety, and slowness of thought and speech. Each item is scored on a scale of 0 to 4, except for the somatic, sleep, and insight items which are scored 0 to 2. On the HAMD-17 there can be a total score of 52. Higher scores represent higher depression severity
Time frame: Baseline, Day 7, Day 14, Day 21, 2-week post-treatment, 4-week post-treatment
change in QID_SR
A provider-administered questionnaire was used to assess remission and recovery from depression. The 16-item QIDS_SR is a widely used self-report instrument covering depressive symptoms incorporating nine Diagnostic and Statistical Manual of Mental Disorder-IV (DSM-IV) diagnostic criteria for major depressive disorders. Each item is scored on a scale of 0 to 4. Higher scores represent higher depression severity.
Time frame: Baseline, Day 7, Day 14, Day 21, 2-week post-treatment, 4-week post-treatment
change in HAMA
The HAMA was one of the first rating scales developed to measure the severity of anxiety symptoms, and is still widely used today in both clinical and research settings. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).
Time frame: Baseline, Day 7, Day 14, Day 21, 2-week post-treatment, 4-week post-treatment
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Changping Laboratory