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

NCT06580249 | Recruiting DMC

• 1 other identifier: KY20242219-C-1
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

pleasure deficit; repetitive transcranial magnetic stimulation; adolescent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Difference in Scores of Patients' HAMD-17 Scores from Baseline to 8 Weeks Post-Treatment

  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

  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

  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.

  at baseline, at the end of treatment on day 14

Study Arms (2)

Repetitive transcranial magnetic stimulation true stimulation and sertraline treatment

EXPERIMENTAL

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.

Device: Repetitive transcranial magnetic stimulation

Sham Repetitive transcranial magnetic stimulation stimulation + sertraline treatment group

SHAM COMPARATOR

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.

Device: Repetitive transcranial magnetic stimulation

Interventions

Repetitive transcranial magnetic stimulation 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。

Repetitive transcranial magnetic stimulation true stimulation and sertraline treatment; Sham Repetitive transcranial magnetic stimulation stimulation + sertraline treatment group

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

XijingH

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Siheng Ma

CONTACT

+8613571652479; matthewsiheng@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: August 30, 2024
• Study Start: September 5, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

CN (1)