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Melanotan-2

MT-II, Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-NH2

Quick Stats
Studies 3
Trials 100
Withdrawn NA INTERVENTIONAL NCT03978182

Accelerated Deep TMS in the Elderly Depressed: A Brain Imaging Approach

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

With a growing number of elderly persons, geriatric depression - associated with important morbidity and mortality- is becoming a significant health problem. Given the risk of polypharmacy and increased side effects, alternative non pharmaceutical treatments such as repetitive transcranial magnetic stimulation (rTMS) may be a solution. Given recent positive results with accelerated rTMS in the elderly depressed, it is of interrest to continue to develop promising non-invasive treatment stimulations. The FDA approved deep brain TMS (dTMS) technique may be a promising option, targeting the brain underneath the neocortex with potentially better response and remission rates. Therefore, in a sham-controlled cross-over fashion, the investigators will treat 44 geriatric depressed patients with accelerated dTMS (5 sessions/day over 4 days only), and evaluate clinical efficacy and safety. Because new introduced rTMS paradigms should be rigorously neurobiologically examined before applying them on a regular basis, this research will include multimodal brain imaging techniques to elucidate the working mechanisms of this application in order to optimize treatment for such populations.

Detailed Description

An initially double-blind sham-controlled cross-over study in geriatric depressed patients to investigate whether accelerated (a)dTMS is a safe and effective clinical option for this cohort. After the first week evaluations and MRI, there will be an open label phase in which patients who did receive active treatment in the first week will not receive any further rTMS sessions, those patients who had received sham however will get their active treatment in the second week. The independent researcher will use the treatment allocation list to inform the investigators if an active treatment faze is needed in the second week.

Interventions

Name: accelerated deep rTMS
Type: DEVICE
Description: A Magstim Rapid2 Plus1 Magnetic Stimulator connected to the Brainsway dTMS system with the H1-coil investigational device (Brainsway Ltd, Jerusalem, Israel). The coil is situated inside a helmet to achieve effective cooling during stimulation. A sham coil is also included in the same helmet. The sham coil mimics scalp sensations and the acoustic artifact of the active stimulation without inducing neuronal activation.

Primary Outcomes

Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
TimeFrame: During 1 week (and 2 weeks for patients who received sham in the first week)
Description: Number of participants with treatment-related adverse events as assessed by questionning the patient on each stimulation day
Measure: clinical efficacy measured by change in the 17 item Hamilton Depression rating Scale score.
TimeFrame: from screening until last visit (week 4)
Description: for a total score between 0 and 48, the higher the total score the more severe the depression. Used measures are : for response (reduction from baseline of ≥ 50% in the total score) and remission (total HAMD-17 score ≤ 7)
Measure: clinical efficacy measured by change in the Beck-Inventory of Depression-II score
TimeFrame: from screening until last visit (week 4)
Description: for a total score between 0 and 63, the higher the total score the more severe the depression. A score of ≤9 is the criterion for remission, and BDI-II score decrease of 50% from baseline is the criterion for treatment response.

Trial Information

NCT ID

NCT03978182

Status

Withdrawn

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Universitair Ziekenhuis Brussel

Last Updated

December 15, 2025