Clinical trial NCT06580249: Efficacy and Mechanism of rTMS on the Symptoms of Pleasure Deficit in Adolescent Depression
Official title: Efficacy and Mechanism of Repetitive Transcranial Magnetic Stimulation on the Symptoms of Pleasure Deficit in Adolescent Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Keywords: pleasure deficit
repetitive transcranial magnetic stimulation
adolescent
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 44
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Depression is one of the most common mental disorders among adolescents and is characterized by persistent low mood. According to a global statistical report released by the World Health Organization, about 350 million people worldwide are affected by depression, with the adolescent population being particularly prominent. Epidemiologic surveys in the Chinese region show that the prevalence of depression in adolescents is about 3.0%. The study points out that age is one of the key factors affecting major depression. Pleasure deficit, a reduced capacity for the experience of pleasure or a lack of appropriate emotional responses to rewards and positive stimuli, is a core symptom of depression and is considered a key internal phenotype of the illness. Repetitive transcranial magnetic stimulation is a treatment for major depressive disorder that delivers a series of equally spaced pulses through repetitive TMS. Studies have shown that rTMS stimulation of the dorsolateral prefrontal cortex can significantly improve symptoms of pleasure deficit. Thus, rTMS may be an effective treatment option for depressed patients with pleasure deficit.

Eligibility criteria: Inclusion Criteria:

1. Age 10-19 years old (both 10 and 19), gender is not limited;
2. Meet the criteria for diagnosing MDD in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
3. First episode or relapse, monophasic or bipolar depressive disorder;
4. No history of any form of antidepressant treatment (including medication, physical and psychotherapy) within 2 weeks prior to enrollment;
5. Habitual right-handedness;
6. Deficit of pleasure scale (DARS) \<22 points;
7. Score \>17 on the 17-item version of the Hamilton Depression Scale (HAMD-17);
8. After fully understanding the safety of rTMS, they were willing to actively cooperate with the treatment and signed an informed consent form.

Exclusion Criteria:

1. Complicated with psychotic symptoms;
2. Comorbidity with major psychiatric disorders such as schizophrenia, delusional disorder, delirium, neurocognitive disorder, intellectual disability, and other mental disorders caused by other diseases;
3. History of primary neurologic disease or brain injury;
4. History of electroconvulsive therapy;
5. 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.

Primary outcomes:
measure: Change in Difference in Scores on the Dimensional Anhedonia Rating Scale (DARS) in Patients from Baseline to 8 Weeks Post-Treatment
timeFrame: 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 outcomes:
measure: Change in Difference in Scores of Patients' HAMD-17 Scores from Baseline to 8 Weeks Post-Treatment
timeFrame: 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
measure: Change in Difference in Scores on the Snaith-Hamilton Pleasure Scale (SHAPS) in Patients from Baseline to 8 Weeks Post-Treatment
timeFrame: 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
measure: Change in Difference in Patient Temporal Experience of Pleasure Scale (TEPS) Scores from Baseline to 8 Weeks Post-Treatment
timeFrame: 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
measure: functional near-infrared spectroscopy tests were performed from baseline to the end of week 2 of treatment.
timeFrame: at baseline, at the end of treatment on day 14
Other outcomes:
Locations:
city: Xi'an
country: China
facility: XijingH
state: Shaanxi
Study officials:
References: