Xijing Hospital
Xi'an, Shaanxi, 710032, China
NCT Number: NCT05544071
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.
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Notify Me13 year–18 year
All sexes
Interventional
Not applicable
Xi'an, Shaanxi, 710032, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Compare active coil with sham coil.
Other names: TMS, Sertraline
Time frame: Pre-treatment and 8-weeks post treatment
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.
Time frame: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)
A provider administered questionnaire used to assess remission and recovery from depression. Scale range - 0 to 52 with higher score indicative of greater depressive symptomology. Additional collection time points were prespecified; only those time points for which data were collected are reported.
Time frame: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)
A diagnostic questionnaire used to measure the severity of depressive symptoms. Scale range - 0 to 60 with higher score indicative of greater depressive symptomology.
Time frame: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)
A 20 item self-assessment questionnaire, eleven items used to measure anticipatory anhedonia, and nine items used to evaluate consummatory anhedonia. Scale range - 0 to 140 with lower score indicative of greater anhedonia symptomology.
Time frame: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)
A 19 item questionnaire used to evaluate the severity of suicidal ideation. The scale includes two subscales of suicidal ideation (Current suicidal ideation, BSI-C) and suicidal ideation (Suicidal ideation at one's worst point, BSI-W) in the last week. Scale range - 0 to 38, the higher the score of the subscale, the higher the level of suicidal ideation in the last week or the most serious.
Time frame: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)
The questionnaire consists of seven items: the severity of insomnia symptoms, the satisfaction of sleep patterns, the effects of insomnia on daytime function, the effects of insomnia on subjects' quality of life, and the degree of worry or depression caused by insomnia. Scale range - 0 to 28 with higher score indicative of greater Insomnia symptomology.
Time frame: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)
The questionnaire used to evaluate the clinical efficacy, it includes three parts: severity of illness (SI), global improvement (GI) and effect index (EI). With higher score indicative of more serious disease and worse effect.
Time frame: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)
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.
Time frame: Time Frame: Pre-treatment, immediately post-treatment (on day 15)
We will assess change in resting state fMRI functional connectivity of the nucleus accumbens to the Dorsolateral Prefrontal Cortex and within the reward-related circuits
Time frame: Time Frame: Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment
THINC-it® is a screening tool designed to measure cognition, is based on a combination of specific (traditional) neuropsychological tests assessing cognitive functioning, in conjunction with a patient-reported questionnaire.
Xijing Hospital
Other
Safety and Efficacy of rTMS on Individualized dlPFC-NAcc Functional Connectivity in Adolescents With Depression and Anhedonia: a Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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