Brainsway DTMS for Treatment of MDD Using iTBS

Status Completed

Clinical Trial Summary

The safety and effectiveness of the BrainsWay deep transcranial magnetic stimulation (DTMS) device for the intended use of Major Depressive Disorder (MDD) using the intermittent theta-burst (iTBS) stimulation protocol will be evaluated in a non-inferiority study, comparing the iTBS treatment with the FDA cleared, (510(k) No. K122288) Brainsway DTMS device to the High Frequency (HF) protocol using the same device.

Clinical Trial Description

The purpose of the study is to evaluate the safety and efficacy of Brainsway Deep TMS for the treatment of Major Depressive Disorder using the iTBS stimulation protocol, by comparing it to clinical data collected in the Brainsway randomized, controlled Multicenter study (CTP-001-00), using the HF DTMS stimulation protocol used in support of the Brainsway DTMS device 510(k) K122288. In the post-marketing study, patients will be treated with an intermittent theta burst (iTBS) protocol, using the same Brainsway DTMS device with the same H1-Coil. Furthermore, the treatment paradigm is the same, consisting of TMS sessions performed daily for 5 weeks (20 DTMS sessions). The iTBS stimulation protocol consists of bursts of 3 pulses at 50 Hz, 5 Hz bursts frequency, 2s on and 8s off, 600 pulses per session. The HF stimulation protocol was delivered at 18 Hz, 120% stimulation intensity of the resting MT, 55 trains of 2s duration, inter-train interval (ITI) of 20s, for 1980 pulses per session. The clinical study design includes multiple measurements of safety and effectiveness parameters. The primary outcome measure is the change from baseline in HDRS-21 scores at the 5 week visit (after 20 treatment sessions). The success criteria of the study is a non-inferiority margin of 3.0 points. The secondary efficacy endpoints of the study include evaluation of the response and remission rates, based on HDRS-21 scores, at the 5 week visit, change in CGI-S score from baseline to 6 weeks and response and remission rates based on CGI-S scores at the 6 week visit. Safety will be assessed at each treatment visit. Patients will be asked to report any adverse event since their previous visit. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04679753
Study type	Interventional
Source	Brainsway
Contact
Status	Completed
Phase	Phase 4
Start date	January 1, 2019
Completion date	July 1, 2020

View Details

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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.