the Safety and Effectiveness of Precise rTMS Based on Neuroimaging in the Treatment of Adolescent Depression With Anhedoniadepression With Anhedonia

NCT05544071 | Unknown DMC

• 1 other identifier: KY20222165-F-1
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates a schedule of precise repetitive transcranial magnetic stimulation for depressive adolescent with anhedonia. In this randomized controlled trial, half of the participants will receive repetitive transcranial magnetic stimulation, and the other will receive sham stimulation.

Conditions

Major Depressive Disorder; Repetitive Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• Percent Change in the Snaith-Hamilton Pleasure Scale (SHAPS)Score From Pre-treatment to 8-weeks

  A 14 item self-assessment questionnaire used to measure the severity of anhedonia symptom in patients with mood disorders. Scale range - 14 to 56 with higher score indicative of greater anhedonia symptomology.

  Pre-treatment and 8-weeks post treatment

Secondary Outcomes (8)

• Percent Change in the Hamilton Rating Scale for Depression (HAM-17)

  Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment

• Percent Change in the Montgomery Asberg Depression Rating Scale (MADRS)

  Time Frame: Pre-treatment to 1 week and15days, 4 weeks, 6 weeks and 8 weeks post-treatment

• Percent Change in the Chinese version of Temporal Experience of Pleasure Scale(CV-TEPS)

  Time Frame: Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment

• Percent Change in the Chinese version of Beck Scale for Suicide Ideation（BSI-CV）

  Time Frame: Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment

• Percent Change in the Insomnia Severity Index Scale （ISI）

  Time Frame: Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment

Other Outcomes (1)

• A digital tool named THINC-it® to help assess cognitive functioning

  Time Frame: Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment

Study Arms (2)

rTMS Active

ACTIVE COMPARATOR

Blinded Active TMS coil. Active repetitive Transcranial Magnetic Stimulation (rTMS) and Sertraline (dosage form: pill, dosage: 50mg, frequency and duration: At the beginning of the treatment, the dose of 25mg/ was taken for 1-3 days and adjusted to 50mg/ days for 4-7 days. If there were no dose-limiting adverse events, the dose could be titrated to 100mg/ days in the second week. The dose could be flexibly adjusted within the range of 100\~150mg/ days until a satisfactory clinical response was achieved. After that, the drug dose was kept unchanged as far as possible. Take it once a day, after a meal at a relatively fixed time in the morning.)

Device: Transcranial Magnetic Stimulation (TMS)

rTMS Sham

SHAM COMPARATOR

Blinded Sham TMS coil. Sham Transcranial Magnetic Stimulation (TMS) and Sertraline (dosage form: pill, dosage: 50mg, frequency and duration: At the beginning of the treatment, the dose of 25mg/ was taken for 1-3 days and adjusted to 50mg/ days for 4-7 days. If there were no dose-limiting adverse events, the dose could be titrated to 100mg/ days in the second week. The dose could be flexibly adjusted within the range of 100\~150mg/ days until a satisfactory clinical response was achieved. After that, the drug dose was kept unchanged as far as possible. Take it once a day, after a meal at a relatively fixed time in the morning.)

Device: Transcranial Magnetic Stimulation (TMS)

Interventions

Transcranial Magnetic Stimulation (TMS) DEVICE

Compare active coil with sham coil.

Also known as: TMS, Sertraline

rTMS Active; rTMS Sham

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female, 13 to 18 years of age.
• According to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Diagnosed with Major Depressive Disorder (MDD) and currently experiencing a Major Depressive Episode (MDE).
• Meet the threshold on the total HAMD17 score of \>/=17 at both screening and baseline visits (Day -7 and Day 0).
• Meet the threshold on the total SHAPS score of \>/=20 at both screening and baseline visits (Day -7 and Day 0).
• Not take any antidepressants for two or more weeks before screening.
• In good general health, as ascertained by medical history.
• After fully understanding the treatment of transcranial magnetic stimulation, willing to cooperate with the treatment actively and able to provide informed consent.

You may not qualify if:

• Current diagnosis of a Substance Use Disorder, with the exception of nicotine and caffeine dependence.
• Current diagnosis of mental disorders other than Dysthymic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, or Specific Phobia (unless one of these is clinically unstable, and/or the focus of the participant's treatment for the past six months or more).
• History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes.
• Any other Mental Disorders, Personality Disorders, Intellectual Disability, which at screening is clinically predominant to their MDD.
• Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results.
• Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.
• Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation.
• History of electronic instrument or metal in the head or skull.
• History of epilepsy.
• History of cardiovascular disease or cardiac event.
• History of OCD.
• History of autism spectrum disorder.
• History of rTMS exposure.
• Other situations judged by the researchers to be unsuitable for the study.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Related Publications (2)

• Zheng K, Chen L, Wang H; DIRECT consortium; Li B, Chen B. Beyond depression symptoms: the default mode network as a predictor of antidepressant response. Npj Ment Health Res. 2026 Jan 16;5(1):2. doi: 10.1038/s44184-025-00182-2.

  PMID: 41545765 DERIVED

• Lv R, Cai M, Tang N, Shi Y, Zhang Y, Liu N, Han T, Zhang Y, Wang H. Active versus sham DLPFC-NAc rTMS for depressed adolescents with anhedonia using resting-state functional magnetic resonance imaging (fMRI): a study protocol for a randomized placebo-controlled trial. Trials. 2024 Jan 13;25(1):44. doi: 10.1186/s13063-023-07814-y.

  PMID: 38218932 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Huaning Wang, doctor

CONTACT

13609161341; xskzhu@fmmu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 16, 2022
• Study Start: February 12, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-10

Locations

CN (1)