Using precise rTMS to treat adolescent depression with anhedonia
A Randomized, Sham-Controlled Trial Evaluating the Safety and Effectiveness of Precise Repetitive Transcranial Magnetic Stimulation (rTMS) Therapy Based on Neuroimaging in Depressed Adolescents With Anhedonia.
This study is testing if a new type of brain stimulation can help teenagers with depression who struggle to feel pleasure, to see if it works better than standard treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 13 Years to 18 Years |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT05544071 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of precise repetitive transcranial magnetic stimulation (rTMS) for adolescents suffering from major depressive disorder (MDD) with anhedonia. In a randomized controlled trial, participants will receive either active rTMS or sham stimulation to assess the treatment's impact on depressive symptoms and neuroimaging biomarkers. The study aims to address the limitations of current antidepressant therapies, particularly for adolescents who do not respond adequately to existing treatments. By focusing on neuroimaging changes, the research seeks to provide insights into the mechanisms of rTMS in this population.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 13 to 18 diagnosed with major depressive disorder currently experiencing a major depressive episode.
Not a fit: Patients with current substance use disorders or other significant mental health disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for adolescents suffering from depression and anhedonia who do not respond to traditional therapies.
How similar studies have performed: Preliminary studies have shown some success with rTMS in treating treatment-resistant depression in adults, but this approach in adolescents is still being explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Xi'an, Shaanxi
- Xijing Hospital — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Study coordinator: Huaning Wang, doctor
- Email: xskzhu@fmmu.edu.cn
- Phone: 13609161341
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.