Efficacy and Mechanism of rTMS on the Symptoms of Pleasure Deficit in Adolescent Depression

NCT ID: NCT06580249

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-05
• Study Completion Date: 2025-12-31

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Repetitive transcranial magnetic stimulation true stimulation and sertraline treatment

The rTMS was administered once a day, implementing approximately 10-20 minutes of physical therapy, with stimulation parameters of 10 Hz frequency, 120% MT intensity, and 50 treatment sequences of 60 stimulations each, with 30-second intervals between the sequences, for a total of 3000 stimulations. For medication: If the depressive episode is only monophasic, give sertraline hydrochloride tablets 1-2 tablets/day for treatment； if the patient has bipolar disorder-depressive episode, give the emotion stabilizer lithium carbonate tablets 0.5-1.0 g/day (adjust the dose according to the blood concentration) for treatment.

Group Type: EXPERIMENTAL

Repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

The true stimulus group acted directly, whereas the pseudo stimulus group reversed the head to produce no effect. Both groups were treated with sertraline medication。

Sham Repetitive transcranial magnetic stimulation stimulation + sertraline treatment group

Pseudo stimulation mimicked the tactile and acoustic sensations of rTMS by flipping the head, at 90 degrees to the scalp, with other intervention parameters remaining consistent with the study group. For medication: If the depressive episode is only monophasic, give sertraline hydrochloride tablets 1-2 tablets/day for treatment； if the patient has bipolar disorder-depressive episode, give the emotion stabilizer lithium carbonate tablets 0.5-1.0 g/day (adjust the dose according to the blood concentration) for treatment.

Group Type: SHAM_COMPARATOR

Repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

The true stimulus group acted directly, whereas the pseudo stimulus group reversed the head to produce no effect. Both groups were treated with sertraline medication。

Interventions

Repetitive transcranial magnetic stimulation

The true stimulus group acted directly, whereas the pseudo stimulus group reversed the head to produce no effect. Both groups were treated with sertraline medication。

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

XijingH

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Siheng Ma

Role: CONTACT

matthewsiheng@outlook.com

+8613571652479

Facility Contacts

Huaning Wang, PhD

Role: primary

xskzhu@fmmu.edu.cn

Other Identifiers

KY20242219-C-1

Identifier Type: -

Identifier Source: org_study_id