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

Air Force Military Medical University of People's Liberation Army

Status: Enrolling

Conditions: Major Depressive Disorder; Repetitive Transcranial Magnetic Stimulation

Treatments: Device: Transcranial Magnetic Stimulation (TMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05544071

KY20222165-F-1

Details and patient eligibility

About

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.

Full description

Repetitive transcranial magnetic stimulation (rTMS) is an established technology as therapy for treatment-resistant depression among adult. The approved method for treatment is 10Hz stimulation over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been successful for many people with treatment-resistant depression. However, a large percentage of adolescents suffering from major depressive disorder (MDD) do not adequately benefit from currently available treatments. One of the limitations is concerns about the safety and efficacy of antidepressant. Recently, researchers have aggressively pursued better treatment strategy such as rTMS to improve adolescent depression with some preliminary success. This study intends to further explore the safety and efficacy of rTMS in the treatment for adolescent major depressive disorder with anhedonia. This study will also look at the change in neuroimaging biomarkers associated with this treatment.

Enrollment: 88 estimated patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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88 participants in 2 patient groups

rTMS Active

Active Comparator group

Description:

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.)

Treatment:

Device: Transcranial Magnetic Stimulation (TMS)

rTMS Sham

Sham Comparator group

Description:

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.)

Treatment:

Device: Transcranial Magnetic Stimulation (TMS)