Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05957341
Study type Interventional
Source Changping Laboratory
Contact Hesheng Liu, Ph.D.
Phone 010-80726688
Email heshengliu@cpl.ac.cn
Status Not yet recruiting
Phase N/A
Start date July 30, 2023
Completion date August 30, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05537558 - Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
Terminated NCT02192099 - Open Label Extension for GLYX13-C-202, NCT01684163 Phase 2
Completed NCT03142919 - Lipopolysaccharide (LPS) Challenge in Depression Phase 2
Recruiting NCT05547035 - Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders N/A
Terminated NCT02940769 - Neurobiological Effects of Light on MDD N/A
Recruiting NCT05892744 - Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression Phase 4
Recruiting NCT05537584 - SMART Trial to Predict Anhedonia Response to Antidepressant Treatment Phase 4
Active, not recruiting NCT05061706 - Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder Phase 3
Completed NCT04479852 - A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder Phase 2
Recruiting NCT04032301 - Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans Phase 1
Recruiting NCT05527951 - Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study N/A
Completed NCT03511599 - Cycloserine rTMS Plasticity Augmentation in Depression Phase 1
Recruiting NCT04392947 - Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation N/A
Recruiting NCT05895747 - 5-HTP and Creatine for Depression R33 Phase Phase 2
Recruiting NCT05273996 - Predictors of Cognitive Outcomes in Geriatric Depression Phase 4
Recruiting NCT05813093 - Interleaved TMS-fMRI in Ultra-treatment Resistant Depression N/A
Recruiting NCT05135897 - The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
Enrolling by invitation NCT04509102 - Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder Early Phase 1
Recruiting NCT06026917 - Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET) Phase 4
Recruiting NCT06145594 - EMA-Guided Maintenance TMS for Depression N/A