Efficacy and Mechanism of rTMS on the Symptoms of Pleasure Deficit in Adolescent Depression
Recruiting · NCT06580249 · Interventional (participants receive a specific treatment) · Lead sponsor: Xijing Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Repetitive transcranial magnetic stimulation
What this trial is about
(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.
Who can take part
Age range
10 Years to 19 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age 10-19 years old (both 10 and 19), gender is not limited;
- Meet the criteria for diagnosing MDD in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
- First episode or relapse, monophasic or bipolar depressive disorder;
- No history of any form of antidepressant treatment (including medication, physical and psychotherapy) within 2 weeks prior to enrollment;
- Habitual right-handedness;
- Deficit of pleasure scale (DARS) \<22 points;
- Score \>17 on the 17-item version of the Hamilton Depression Scale (HAMD-17);
- After fully understanding the safety of rTMS, they were willing to actively cooperate with the treatment and signed an informed consent form.
Exclusion criteria
- Complicated with psychotic symptoms;
- Comorbidity with major psychiatric disorders such as schizophrenia, delusional disorder, delirium, neurocognitive disorder, intellectual disability, and other mental disorders caused by other diseases;
- History of primary neurologic disease or brain injury;
- History of electroconvulsive therapy;
- Contraindications to rTMS treatment, including cardiac pacemakers, neurostimulators, artificial metal heart valves, intracranial aneurysm clips, cochlear implants, and other types of metal implants (with the exception of oral supports);(6)History of epilepsy.
Where it is running
1 location listed.
- XijingH - Xi'an, Shaanxi, China