Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ruijin Hospital
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age : 18 to 60 years (inclusive), any gender.
Diagnosis : Major depressive episode diagnosed by study physicians according to the Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5), with no restriction on first-onset or recurrent episodes.
Symptom Severity : 17-item Hamilton Depression Rating Scale (HAMD-17) score ≥ 17 at screening.
Treatment Stability : Antidepressant regimen must remain unchanged from 30 days prior to signing informed consent through the study duration. Patients using \>2 antidepressants or combinations of antidepressant(s) + augmenting agent(s) must be adjusted to ≤2 agents\* ≥1 week prior to enrollment.
Cognitive Capacity : Sufficient literacy and comprehension skills to complete study assessments.
Compliance : Investigator-confirmed understanding of study objectives/procedures, protocol compliance, and provision of written informed consent.
Medical Devices : Intracranial/cardiac metallic implants or electronic medical devices (e.g., pacemakers, deep brain stimulation systems)
Recent Interventions : Electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or other neuromodulation therapies within 30 days prior to enrollment
Clinical Instability : Acute suicidality (e.g., active suicidal ideation with intent) Inability to complete study follow-up per investigator judgment
Concurrent Trials : Participation in other interventional clinical studies during the trial period
Reproductive Status : Pregnancy, lactation, or plans for conception during the trial
Suicide Risk : Score ≥3 on Item 3 of the 17-item Hamilton Depression Rating Scale (HAMD-17)
Any condition deemed to compromise subject safety or study validity per clinical evaluation
Clareo Health | 6 Weeks Right-Amygdala TIS for Depression
