Efficacy and Mechanism of rTMS on the Symptoms of Pleasure Deficit in Adolescent Depression
NCT Number: NCT06580249
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression
Interventions: DEVICE: Repetitive transcranial magnetic stimulation
Sponsor: Xijing Hospital
Sex: ALL
Age: CHILD, ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-12-31
Locations: XijingH, Xi'an, Shaanxi, 710032, China

Summary:
(1) Primary objective: to collect data on the score of pleasure deficit scale before and after repetitive transcranial magnetic stimulation treatment in adolescent depressed patients, and to verify its efficacy and safety in adolescent depressed patients in combination with the changes of clinical symptoms; (2) Secondary objective: to explore the relevant hemodynamic mechanisms in adolescent depressed patients before and after repetitive transcranial magnetic stimulation treatment.

Primary Outcome Measures: Change in Difference in Scores on the Dimensional Anhedonia Rating Scale (DARS) in Patients from Baseline to 8 Weeks Post-Treatment, The Dimensional Anhedonia Rating Scale, a relatively new tool for assessing symptoms of pleasure deficit, is a self-rating scale. It consists of four sections and 17 questions that focus on the patient's experience of pleasure in the present moment. Each question is rated on a 5-point scale of 1 (never), 2 (occasionally), 3 (sometimes), 4 (often), and 5 (always).The lower the DARS score, the greater the degree of pleasure deficit., at baseline, at the end of treatment on day 7, at the end of treatment on day 14, 4 weeks after treatment, and 8 weeks after treatment
Secondary Outcome Measures: Change in Difference in Scores of Patients' HAMD-17 Scores from Baseline to 8 Weeks Post-Treatment, The Hamilton Depression Scale has 17 entries, each of which is categorized into either 5 levels or 3 levels. The higher the patient's score, the more severe the depression., at baseline, at the end of treatment on day 7, at the end of treatment on day 14, 4 weeks after treatment, and 8 weeks after treatment|Change in Difference in Scores on the Snaith-Hamilton Pleasure Scale (SHAPS) in Patients from Baseline to 8 Weeks Post-Treatment, The Snaith-Hamilton Pleasure Scale has 14 entries, each of which is categorized into 4 levels. The higher the patient's score, the more severe the pleasure deficit., at baseline, at the end of treatment on day 7, at the end of treatment on day 14, 4 weeks after treatment, and 8 weeks after treatment|Change in Difference in Patient Temporal Experience of Pleasure Scale (TEPS) Scores from Baseline to 8 Weeks Post-Treatment, The Temporal Experience of Pleasure Scale has 20 entries, each of which is categorized into 6 levels. The lower the patient's score, the more severe the pleasure deficit., at baseline, at the end of treatment on day 7, at the end of treatment on day 14, 4 weeks after treatment, and 8 weeks after treatment|functional near-infrared spectroscopy tests were performed from baseline to the end of week 2 of treatment., Before and after treatment, near-infrared functional brain imaging was performed on each patient to monitor blood oxygen levels in each brain region and ultimately to compare hemodynamic changes before and after treatment., at baseline, at the end of treatment on day 14