Blood Markers and Response to Magnetic Stimulation for Hard-to-Treat Depression

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with major depression who did not respond to at least two antidepressants and are about to start TMS (magnetic brain stimulation) treatment. Blood samples are used to look for markers of how well TMS works.

Age

18 to 65 years

Sex

All sexes can join.

Disease stage

Major depressive disorder (DSM-5-TR) that did not respond enough to at least two different antidepressants and/or anti-obsessive medicines at proper doses and durations.

Earlier treatment

At least two different antidepressants and/or anti-obsessive medicines at therapeutic doses and durations, without enough response.

Biomarker or test result

No epileptic activity on routine EEG before TMS. Normal thyroid hormones, no significant vitamin deficiencies, no markedly raised inflammation markers, and no electrolyte imbalance in routine blood tests.

Main reasons for not taking part

• Any contraindication to TMS on the standard pre-TMS risk form
• History of significant head trauma, loss of consciousness or brain surgery
• Metal implants or foreign bodies that do not fit with TMS
• History of psychotic disorder or bipolar I/II disorder
• Current or past substance use disorder, unless off substances (except alcohol) for at least 12 months

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 65 years old?YesNo

What the trial wants to find out

Transcranial Magnetic Stimulation (TMS) therapy is an approved and effective treatment option for treatment-resistant depression (TRD). This study aims to identify biomarkers that predict TMS treatment response in TRD, provide insights into the neurobiological mechanisms underlying TMS efficacy, and contribute to personalized treatment strategies. By establishing proteomic and metabolomic signatures, this research seeks to enhance clinical decision-making, reduce healthcare costs, and improve patient outcomes in TRD. The findings will align with the precision medicine movement in psychiatry, advancing biomarker-driven therapeutic approaches for treatment-resistant depression.

The group in the trial

• Transcranial Magnetic Stimualtion Treatment ArmTreatment being tested

  This arm includes participants diagnosed with treatment-resistant depression (TRD) who will receive transcranial magnetic stimulation (TMS) therapy. TMS will be delivered using the MagVenture™ X100™ device. The treatment protocol consists of 20 sessions over a 4-week period (5 sessions per week). Stimulation will target the left dorsolateral prefrontal cortex (DLPFC) using intermittent theta burst stimulation (iTBS). Motor threshold will be determined at baseline and reassessed weekly to calibrate stimulation intensity at 90% of the resting motor threshold. Blood samples will be collected from participants at two time points: prior to the first TMS session (pre-treatment) and following the final (20th) session (post-treatment). Proteomic and metabolomic analyses will be performed using high-resolution liquid chromatography-mass spectrometry (LC-MS). The goal is to identify differentially expressed proteins and metabolites associated with clinical response to TMS.

  Treatment: TMS