CompletedPhase 2

Neuronavigation Guided iTBS With Personalized Target for Depression

China68 participantsStarted 2023-07-10

Plain-language summary

The study will compare the efficacy of intermittent Theta Burst Stimulation (iTBS) with DLPFC-pgACC personalized target for major depressive disorder (MDD) and explore possible brain network mechanisms. The stimulated targets will be located by magnetic resonance imaging (MRI) based on functional MRI based on functional connectivity respectively. This study aims to identify that functional connectivity targeted iTBS protocols on DLPFC-pgACC personalized target have a better antidepressant efficacy compared the sham group and certify that pgACC is an effective potential effector target.

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion Criteria: * 18 to 60 years old * Meet the criteria of the Diagnostic and Statistical Manual of Mental Disorder- V of MDD, single or recurrent * Meet the threshold on the total HAMD17 score of \>17 at both screening and baseline visits * Able to provide informed consent Exclusion Criteria: * any other current or past psychiatric axis-I or axis-II disorders * severe physical illnesses * psychotic symptoms, alcohol or drug abuse * A history of neurological disorders including seizure, cerebral trauma * MRI evidence of structural brain abnormalities * Contraindications to MRI and rTMS * Acute suicide * Female that is pregnant or breastfeeding

What they're measuring

Change in the 17-Item Hamilton Rating Scale for Depression (HAMD-17) Score from Baseline to 4 weeks post treatment

Timeframe: baseline and 4-week post treatment

Trial details

NCT IDNCT05577481

SponsorXijing Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-30

View on ClinicalTrials.gov More Depression trials