ipRGC as a Potential Biomarker for Predicting Transcranial Magnetic Stimulation Treatment Response in Major Depressive Disorder
Recruiting · NCT07474974 · Interventional (participants receive a specific treatment) · Lead sponsor: Polytechnic Institute of Porto
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This research explores the potential of retinal ganglion cells (RGCs), particularly intrinsically photosensitive RGCs (ipRGCs), as biomarkers for predicting response to transcranial magnetic stimulation (TMS) in treatment-resistant depression (TRD). We also aim to assess the impact of TMS treatment on RGCs and ipRGCs in TRD patients, investigating associations with clinical improvements and cognitive status. A clinical trial involving 44 patients with treatment-resistant depression (TRD) will be conducted. All participants will receive rTMS targeting the dorsolateral prefrontal cortex (DLPFC). Data will be collected pre- and post-intervention, as well as at a 2-month follow-up, using multiple outcome measures, including the post-illumination pupil response (PIPR). The project seeks to confirm the effectiveness of TMS and the potential of RGCs/ipRGCs as predictors of treatment response, thereby facilitating the development of personalized treatment strategies for TRD patients undergoing rTMS therapy.
Who can take part
Inclusion criteria
- Diagnosis of MDD, confirmed via the structured clinical interview;
- TRD type;
- Age between 18-65 years;
- Visual acuity of 20/32 or better.
Exclusion criteria
- Prior rTMS treatment;
- Contraindications for TMS;
- Psychiatric disorders other than MDD;
- Systemic diseases affecting the eyes (e.g., diabetes mellitus);
- Ocular conditions;
- Head injuries causing loss of consciousness;
- Current or past alcohol/substance dependence within 6 months;
- Neurodegenerative diseases;
- Major neurological illnesses;
- Use of medications affecting iris mechanics or the autonomic nervous system.
Where it is running
1 location listed.
- RISE-Health, Center for Translational Health and Medical Biotechnology Research (TBIO), School of Health, Polytechnic of Porto - Porto, Porto District, Portugal