Clinical trial NCT05544071: the Safety and Effectiveness of Precise rTMS Based on Neuroimaging in the Treatment of Adolescent Depression With Anhedoniadepression With Anhedonia
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Repetitive Transcranial Magnetic Stimulation
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 88
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Percent Change in the Snaith-Hamilton Pleasure Scale (SHAPS)Score From Pre-treatment to 8-weeks
timeFrame: Pre-treatment and 8-weeks post treatment
Secondary outcomes:
measure: Percent Change in the Hamilton Rating Scale for Depression (HAM-17)
timeFrame: Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment
measure: Percent Change in the Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: Time Frame: Pre-treatment to 1 week and15days, 4 weeks, 6 weeks and 8 weeks post-treatment
measure: Percent Change in the Chinese version of Temporal Experience of Pleasure Scale(CV-TEPS)
timeFrame: Time Frame: Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment
measure: Percent Change in the Chinese version of Beck Scale for Suicide Ideation（BSI-CV）
timeFrame: Time Frame: Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment
measure: Percent Change in the Insomnia Severity Index Scale （ISI）
timeFrame: Time Frame: Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment
measure: Percent Change in the Clinical Global Impression (CGI)
timeFrame: Time Frame: Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment
measure: Percent Change in the Snaith-Hamilton Pleasure Scale (SHAPS)
timeFrame: Time Frame: Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment
measure: Change From Baseline Functional Connectivity to 15-days Post-treatment
timeFrame: Time Frame: Pre-treatment, immediately post-treatment (on day 15)
Other outcomes:
measure: A digital tool named THINC-it® to help assess cognitive functioning
timeFrame: Time Frame: Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
References: