Werkzaamheid en veiligheid van beeldvorming met magnetische resonantie-geleide repetitieve transcraniële magnetische stimulatie (RTMS) bij adolescenten met depressie: een gerandomiseerde, dubbelblinde, gecontroleerde pilotstudie
Studie Overzicht
Toestand
Gedetailleerde beschrijving
Deze studie is een gerandomiseerde, dubbelblinde, gecontroleerde pilotstudie gericht op het evalueren van de haalbaarheid, veiligheid, aanvaardbaarheid en voorlopige werkzaamheidstrends van beeldvorming van magnetische resonantie-geleide repetitieve transcraniële magnetische stimulatie (RTMS) voor de behandeling van adolescente depressie.
Adolescenten gediagnosticeerd met een ernstige depressieve stoornis (MDD) worden willekeurig toegewezen in een 1: 1: 1 -verhouding tot een van de drie groepen: de experimentele Target RTMS -behandelingsgroep, de conventionele doel RTMS -behandelingsgroep en de Sham -stimulatiegroep. Alle drie de groepen ontvangen 4 weken RTMS-stimulatie (10 Hz, 120% RMT) of schijnstimulatie-interventie, met behulp van de Blackdolphin TMS-robot (SLD-YXRJ) door Xi'an Solide Brain Modulation Ltd. Co., met 20 sessies (op weekdagen toegediend) in totaal. De interventiefrequentie en -procedure blijven consistent in alle groepen.
In de experimentele doelgroep RTMS zullen deelnemers MRI-geleide identificatie ondergaan van de linker dorsolaterale prefrontale cortex (DLPFC) -regio (DLPFC), waar de voxel het meest negatief gecorreleerd is met de functionele connectiviteit van de subgenuele anterior cingulate cortex (SGACC) als het stimulatie doelwit. In de conventionele Target RTMS -behandelingsgroep hebben deelnemers het standaard F3 -doel in de DLPFC geïdentificeerd via MRI -begeleiding als stimulatieplaats. Deelnemers aan de schijnstimulatiegroep krijgen een placebo -behandeling, die de RTMS -procedure simuleren zonder een effectieve magnetische velduitgang te genereren.
De primaire uitkomst van de behandelingsfase is de werkzaamheidssnelheid of de remissiepercentage van depressieve symptomen. Secundaire resultaten omvatten symptoomschalen, angstsymptomen, zelfmoordrisico, kwaliteit van leven, slaap, herkauwen en cognitie. Veiligheid zal worden gevolgd door bijwerkingen, vitale tekenen, laboratoriumtests en verdraagbaarheidsbeoordelingen.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Xinyu Zhou
- Telefoonnummer: 15823996993
- E-mail: zhouxinyu@cqmu.edu.cn
Studie Locaties
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Chongqing, China
- Werving
- The First Affiliated Hospital of Chongqing Medical University
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Contact:
- Xinyu Zhou
- Telefoonnummer: 15823996993
- E-mail: zhouxinyu@cqmu.edu.cn
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
Inclusiecriteria:
- Leeftijd 12 - 18
- Diagnose van de belangrijkste depressieve stoornis (MDD) volgens de diagnostische en statistische handleiding voor psychische stoornissen, vijfde editie (DSM-5), bevestigd door het kinderschema voor affectieve stoornissen en schizofrenie-aanwezig en levenslange versie (K-SADS-PL), momenteel in een depressieve aflevering
- Score ≥40 op de CDRS-R
- Stabiele farmacologische behandeling: ten minste 4 weken stabiel psychiatrisch medicijngebruik voorafgaand aan de inschrijving, met voortzetting van hetzelfde psychiatrische medicatieregime tijdens de studie.
Uitsluitingscriteria:
- Psychiatrische comorbiditeiten anders dan angststoornissen
- Depressie met psychotische symptomen
- Young Mania Rating Scale (YMRS) score> 13
- Een geschiedenis van neurologische aandoeningen (bijv. Epilepsie, hersenletsel) of ernstige somatische ziekten (bijv. Schildklieraandoeningen, lupus, diabetes, long-, lever-, of nierstoornissen, groot trauma)
- Patiënten die momenteel anticonvulsiva of hoge dosis benzodiazepines gebruiken
- Een geschiedenis van elektroconvulsietherapie (ECT), transcraniële magnetische stimulatie (TMS), transcraniële directe stroomstimulatie (TDC's), transcraniële wisselstroomstimulatie (TAC's) of andere neuromodulatiebehandelingen
- Een geschiedenis van alcohol- of middelenmisbruik of afhankelijkheid
- Vrouwen die zwanger zijn of borstvoeding geven
- Huidig hoog zelfmoordrisico
- Potentiële complicerende factoren gerelateerd aan transcraniële magnetische stimulatie, zoals hoofdhuidomstandigheden of perforaties die de magnetische veldafgifte kunnen beïnvloeden
- Contra -indicaties voor MRI
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Experimentele doel RTMS -behandelingsgroep
Deelnemers zullen MRI-geleide identificatie van de voxel ondergaan in de linker dorsolaterale prefrontale cortex (DLPFC) die het meest negatief is gecorreleerd met de functionele connectiviteit van de subgenual anterior cingulate cortex (SGACC) als de stimulatieplaats.
Repetitieve transcraniële magnetische stimulatie (RTMS) (10 Hz, 120% RMT) wordt toegediend met behulp van het Blackdolphin TMS-robotapparaat (model SLD-YXRJ) door Xi'an Solide Brain Modulation Ltd.
Co., met 20 sessies gedurende 4 weken (behandeling toegediend op weekdagen).
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Deelnemers zullen MRI-geleide identificatie van de voxel ondergaan in de linker dorsolaterale prefrontale cortex (DLPFC) die het meest negatief is gecorreleerd met de functionele connectiviteit van de subgenual anterior cingulate cortex (SGACC) als de stimulatieplaats.
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Sham-vergelijker: Schijnstimulatiebehandelingsgroep
Deelnemers krijgen een schijnstimulatiebehandeling die is ontworpen om de RTMS -procedure te simuleren zonder een effectieve magnetische velduitgang te genereren.
De interventie zal een speciale schijnstimulatiespoel gebruiken, die identiek is in uiterlijk, werking en stimulatieprotocol voor de experimentele groep.
Deze spoel is ontworpen om dezelfde auditieve en tactiele sensaties te behouden als de actieve stimulatie, maar is uitgerust met een elektromagnetische afschermingsstructuur of een interne omgekeerde spoelopstelling om te voorkomen dat magnetische flux de schedel doordringt, waardoor geen werkelijke neuromodulerende effecten worden gewaarborgd.
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Deelnemers krijgen een schijnstimulatiebehandeling die is ontworpen om de RTMS -procedure te simuleren zonder een effectieve magnetische velduitgang te genereren.
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Experimenteel: Conventionele doelgroep rTMS-behandelingsgroep
Deelnemers zullen MRI-gestuurde stimulatie ontvangen op de linker DLPFC-locatie.
Repetitieve transcraniële magnetische stimulatie (rTMS) (10 Hz, 120% RMT) wordt toegediend met behulp van het Blackdolphin TMS Robot-apparaat (model SLD-YXRJ) van Xi'an Solide Brain Modulation Ltd.
Co., met 20 sessies over 4 weken (behandeling toegediend op werkdagen).
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deelnemers zullen MRI-gestuurde stimulatie ontvangen op de linker DLPFC-locatie.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Recruitment Feasibility (Number of Participants Enrolled)
Tijdsspanne: 2 years
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The total number of participants successfully enrolled in this study will be recorded to assess recruitment feasibility.
The goal is to recruit 45 participants (15 in each of the three groups) over a 2-year period.
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2 years
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Intervention adherence (number of participants who completed the full 20 treatment sessions)
Tijdsspanne: Throughout the entire course of treatment (up to 1 month)
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This outcome measure will assess participants' adherence to the 20 sessions of transcranial magnetic stimulation.
Adherence is defined as completing all 20 sessions.
Adherence is calculated by dividing the number of participants who met this criterion by the total number of participants.
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Throughout the entire course of treatment (up to 1 month)
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Retention Rate (Number of Participants Remaining at 6-Month Follow-up)
Tijdsspanne: Throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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This outcome measure will assess the proportion of participants still enrolled in the study at the 6-month follow-up assessment.
Retention rate is calculated as the number of participants who completed the 6-month assessment divided by the number of participants enrolled at baseline.
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Throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Response rate and remission rate of depressive symptoms
Tijdsspanne: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Preliminary clinical efficacy will be assessed by change in the Children's Depression Rating Scale-Revised (CDRS-R) total score from baseline.
CDRS-R is a clinician-rated scale used to assess the severity of depressive symptoms in children and adolescents.
It consists of 17 items, and the total score ranges from 17 to 113.
Higher scores indicate more severe depressive symptoms.
Changes in CDRS-R total score from baseline will be assessed at the end of treatment and at follow-up visits.
Response rate of depressive symptoms will be defined as a ≥50% reduction in CDRS-R total score from baseline, and remission rate of depressive symptoms will be defined as a CDRS-R total score ≤28.
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Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Incidence of Adverse Events and Serious Adverse Events
Tijdsspanne: Throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Adverse events, abbreviated as AEs, and serious adverse events, abbreviated as SAEs, will be assessed to evaluate the safety and tolerability of the intervention.
An AE is defined as any unfavorable medical occurrence in a participant during the study period, regardless of whether it is considered related to the intervention.
An SAE is defined as any adverse event that results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, or is otherwise considered medically significant.
The number and proportion of participants experiencing at least one AE or SAE will be recorded throughout the study period.
The severity, outcome, and relationship to the intervention will also be documented.
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Throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in BDI-II (Beck Depression Inventory-II) scores from baseline
Tijdsspanne: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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The Beck Depression Inventory-II, abbreviated as BDI-II, is a 21-item self-report scale used to measure the severity of depressive symptoms.
Each item is scored from 0 to 3, and the total score ranges from 0 to 63.
Higher scores indicate more severe depressive symptoms.
Changes in BDI-II total score from baseline will be assessed at the end of treatment and at follow-up visits.
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Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Change in HAMA score from baseline
Tijdsspanne: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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The Hamilton Anxiety Rating Scale, abbreviated as HAMA, is a clinician-rated scale used to assess the severity of anxiety symptoms.
It consists of 14 items covering both psychic anxiety and somatic anxiety symptoms.
Each item is scored from 0 to 4, and the total score ranges from 0 to 56.
Higher scores indicate more severe anxiety symptoms.
Changes in HAMA total score from baseline will be assessed at the end of treatment and at follow-up visits.
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Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) scores from baseline
Tijdsspanne: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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The Screen for Child Anxiety Related Emotional Disorders, abbreviated as SCARED, is a self-report scale used to assess anxiety symptoms in children and adolescents.
The total score ranges from 0 to 82, with higher scores indicating more severe anxiety symptoms.
The change in SCARED total score from baseline will be calculated at each post-baseline assessment time point.
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Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale)
Tijdsspanne: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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The Columbia-Suicide Severity Rating Scale, abbreviated as C-SSRS, is a clinician-administered scale used to assess suicidal ideation and suicidal behavior.
The C-SSRS Suicidal Ideation Severity Score ranges from 0 to 5, where 0 indicates no suicidal ideation and higher scores indicate more severe suicidal ideation.
The change in C-SSRS Suicidal Ideation Severity Score from baseline will be calculated at each post-baseline assessment time point.
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Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline
Tijdsspanne: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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The Pittsburgh Sleep Quality Index, abbreviated as PSQI, is a self-report questionnaire used to assess sleep quality and sleep disturbances over the past month.
The 19 self-rated items are used to generate seven component scores, including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Each component score ranges from 0 to 3, and the global PSQI score ranges from 0 to 21.
Higher scores indicate poorer sleep quality.
Changes in the global PSQI score from baseline will be assessed at the end of treatment and at follow-up visits.
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Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline
Tijdsspanne: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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The Clinical Global Impression-Severity scale, abbreviated as CGI-S, is a clinician-rated scale used to assess the overall severity of illness at the time of evaluation.
It is rated on a 7-point scale, ranging from 1 = normal, not at all ill to 7 = among the most extremely ill patients.
Higher scores indicate greater illness severity.
Changes in CGI-S score from baseline will be assessed at the end of treatment and at follow-up visits.
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Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Change in CGI-I (Clinical Global Impressions-Improvement Scales) scores from baseline
Tijdsspanne: Throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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The Clinical Global Impression-Improvement scale, abbreviated as CGI-I, is a clinician-rated scale used to assess the overall change in a participant's clinical condition compared with baseline.
It is rated on a 7-point scale, ranging from 1 = very much improved to 7 = very much worse.
Lower scores indicate greater clinical improvement.
CGI-I scores will be assessed at the end of treatment and at follow-up visits.
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Throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Change in RRS (Ruminative Responses Scale)
Tijdsspanne: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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The Ruminative Responses Scale, abbreviated as RRS, is a self-report scale used to assess the tendency to engage in ruminative thinking in response to depressed mood.
The full version consists of 22 items, and each item is rated on a 4-point scale, ranging from 1 to 4. The total score ranges from 22 to 88.
Higher scores indicate greater levels of rumination.
Changes in RRS total score from baseline will be assessed at the end of treatment and at follow-up visits.
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Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Change in PedsQL 4.0 score from baseline
Tijdsspanne: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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The Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales, abbreviated as PedsQL 4.0, is a standardized questionnaire used to assess health-related quality of life in children and adolescents.
It consists of 23 items covering four domains: physical functioning, emotional functioning, social functioning, and school functioning.
Raw item scores are reverse-scored and linearly transformed to a 0 to 100 scale, with 0=100, 1=75, 2=50, 3=25, and 4=0.
The total scale score is calculated as the mean of all answered items, with higher scores indicating better health-related quality of life.
Changes in PedsQL 4.0 total score from baseline will be assessed at the end of treatment and at follow-up visits.
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Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Medewerkers en onderzoekers
Publicaties en nuttige links
Algemene publicaties
- George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.
- March J, Silva S, Petrycki S, Curry J, Wells K, Fairbank J, Burns B, Domino M, McNulty S, Vitiello B, Severe J; Treatment for Adolescents With Depression Study (TADS) Team. Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents With Depression Study (TADS) randomized controlled trial. JAMA. 2004 Aug 18;292(7):807-20. doi: 10.1001/jama.292.7.807.
- O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007 Dec 1;62(11):1208-16. doi: 10.1016/j.biopsych.2007.01.018. Epub 2007 Jun 14.
- Allen CH, Kluger BM, Buard I. Safety of Transcranial Magnetic Stimulation in Children: A Systematic Review of the Literature. Pediatr Neurol. 2017 Mar;68:3-17. doi: 10.1016/j.pediatrneurol.2016.12.009. Epub 2017 Jan 4.
- Hetrick SE, McKenzie JE, Bailey AP, Sharma V, Moller CI, Badcock PB, Cox GR, Merry SN, Meader N. New generation antidepressants for depression in children and adolescents: a network meta-analysis. Cochrane Database Syst Rev. 2021 May 24;5(5):CD013674. doi: 10.1002/14651858.CD013674.pub2.
- Brent D, Emslie G, Clarke G, Wagner KD, Asarnow JR, Keller M, Vitiello B, Ritz L, Iyengar S, Abebe K, Birmaher B, Ryan N, Kennard B, Hughes C, DeBar L, McCracken J, Strober M, Suddath R, Spirito A, Leonard H, Melhem N, Porta G, Onorato M, Zelazny J. Switching to another SSRI or to venlafaxine with or without cognitive behavioral therapy for adolescents with SSRI-resistant depression: the TORDIA randomized controlled trial. JAMA. 2008 Feb 27;299(8):901-913. doi: 10.1001/jama.299.8.901.
- Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
- Croarkin PE, Elmaadawi AZ, Aaronson ST, Schrodt GR Jr, Holbert RC, Verdoliva S, Heart KL, Demitrack MA, Strawn JR. Left prefrontal transcranial magnetic stimulation for treatment-resistant depression in adolescents: a double-blind, randomized, sham-controlled trial. Neuropsychopharmacology. 2021 Jan;46(2):462-469. doi: 10.1038/s41386-020-00829-y. Epub 2020 Sep 12.
- Sigrist C, Vockel J, MacMaster FP, Farzan F, Croarkin PE, Galletly C, Kaess M, Bender S, Koenig J. Transcranial magnetic stimulation in the treatment of adolescent depression: a systematic review and meta-analysis of aggregated and individual-patient data from uncontrolled studies. Eur Child Adolesc Psychiatry. 2022 Oct;31(10):1501-1525. doi: 10.1007/s00787-022-02021-7. Epub 2022 Jun 24.
- Berlim MT, Van den Eynde F, Daskalakis ZJ. Efficacy and acceptability of high frequency repetitive transcranial magnetic stimulation (rTMS) versus electroconvulsive therapy (ECT) for major depression: a systematic review and meta-analysis of randomized trials. Depress Anxiety. 2013 Jul;30(7):614-23. doi: 10.1002/da.22060. Epub 2013 Jan 24.
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Andere studie-ID-nummers
- 1stChongqingCQMU___ZXY
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