Temporal interference stimulation to improve social reward function in depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants aged 16–60 who meet DSM-5 criteria for major depressive disorder and have moderate-to-severe symptoms will receive temporal interference stimulation (TIS) at Shanghai Mental Health Center. The intervention uses noninvasive, patterned electromagnetic fields intended to modulate deep brain networks involved in social reward, with clinical and neural/behavioral outcomes measured before and after treatment. Key inclusion criteria include HAMD-24 ≥20, HAMA and HCL-32 <14, and at least two atypical depressive symptoms; exclusions include prior mania/hypomania, severe medical or neurological conditions, pregnancy, or active suicidality. The protocol aims to link changes in neural activity produced by TIS to measurable improvements in social functioning.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 16-60 years old;
* Meeting with the criteria of major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5;
* Scored 20 or higher on the Hamilton's Depression Scale with 24 items (HAMD-24);
* With enough audio-visual ability and comprehensive ability to accomplish the visits;
* Be necessary and suitable to accept the treatment of antidepressants;
* Scored less than 14 on Hamilton's Anxiety Scale (HAMA) and scored less than 14 on the Hypomania Symptom Checklist-32 (HCL-32);
* With 2 or more atypical symptoms including significant weight gain or increase in appetite, hypersomnia, leaden paralysis, and a long-standing pattern of interpersonal rejection sensitivity that results in significant social or occupational impairment.

Exclusion Criteria:

* Severe medical or neurological problems;
* Previous mania or hypomania episodes;
* Female patients who are pregnant, planning to be pregnant or breastfeeding;
* Actively suicide ascertained by research psychiatrist or 3rd item of HAMD scored≥3(suicidality);
* Had ECT, MECT or rTMS in the past 6 months;
* Experienced severe personality disorder, mental retardation, anorexia/ bulimia nervosa.

Where it's running

• Shanghai Mental Health Center
  Shanghai, China, China Recruiting

Study contacts

• Study coordinator: daihui Peng, MD. PhD.
• Email: pdhsh@126.com
• Phone: 18017311136

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.