drugset / Trial / NCT04780152
TDCS in Pediatric and Teenage Patients With Major Depressive Disorder During COVID-19 Pandemic
Phase 2/3
Unknown
172 enrolled
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to assess safety and efficacy of nodal transcranial direct current stimulation in pediatric and teenager population with major depressive disorder in the COVID-19 pandemic.
Timeline
- Start
- 2021-10
- Primary completion
- 2022-08
- Completion
- 2022-09
Publications
- Background (Editors) Medina Mora, M.E. & Sarti Gutierrez, E.J. & Real Quintanar, T. (2015) 'La depresión y otros trastornos psiquiátricos. Documento de postura.', Colección, p. 410. Available at: [email protected] (reproducci? prohibida) (Accessed: 11 May 2020).
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- Background Acosta-Hernández, M. E. et al. (2011) 'Depresión en la infancia y adolescencia: Enfermedad de nuestro tiempo', Archivos de Neurociencias, 16(1), pp. 20-25.
- Background Al-Halabi S, Saiz PA, Buron P, Garrido M, Benabarre A, Jimenez E, Cervilla J, Navarrete MI, Diaz-Mesa EM, Garcia-Alvarez L, Muniz J, Posner K, Oquendo MA, Garcia-Portilla MP, Bobes J. Validation of a Spanish version of the Columbia-Suicide Severity Rating Scale (C-SSRS). Rev Psiquiatr Salud Ment. 2016 Jul-Sep;9(3):134-42. doi: 10.1016/j.rpsm.2016.02.002. Epub 2016 May 2. English, Spanish.
- Background Alon, G., Syron, S. C. and Smith, G. V. (1998) 'Is Transcranial Electrical Stimulation (TCES) a Safe Intervention for Children with Cerebral Palsy?', Neurorehabilitation and Neural Repair, 12(2), pp. 65-71. doi: 10.1177/154596839801200204
- Background Alonzo A, Fong J, Ball N, Martin D, Chand N, Loo C. Pilot trial of home-administered transcranial direct current stimulation for the treatment of depression. J Affect Disord. 2019 Jun 1;252:475-483. doi: 10.1016/j.jad.2019.04.041. Epub 2019 Apr 10.
- Background Ardolino G, Bossi B, Barbieri S, Priori A. Non-synaptic mechanisms underlie the after-effects of cathodal transcutaneous direct current stimulation of the human brain. J Physiol. 2005 Oct 15;568(Pt 2):653-63. doi: 10.1113/jphysiol.2005.088310. Epub 2005 Jul 21.
- Background Bandeira ID, Guimaraes RS, Jagersbacher JG, Barretto TL, de Jesus-Silva JR, Santos SN, Argollo N, Lucena R. Transcranial Direct Current Stimulation in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD): A Pilot Study. J Child Neurol. 2016 Jun;31(7):918-24. doi: 10.1177/0883073816630083. Epub 2016 Feb 15.
- Background Batsikadze G, Moliadze V, Paulus W, Kuo MF, Nitsche MA. Partially non-linear stimulation intensity-dependent effects of direct current stimulation on motor cortex excitability in humans. J Physiol. 2013 Apr 1;591(7):1987-2000. doi: 10.1113/jphysiol.2012.249730. Epub 2013 Jan 21.
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- Background Brunoni AR, Vanderhasselt MA, Boggio PS, Fregni F, Dantas EM, Mill JG, Lotufo PA, Bensenor IM. Polarity- and valence-dependent effects of prefrontal transcranial direct current stimulation on heart rate variability and salivary cortisol. Psychoneuroendocrinology. 2013 Jan;38(1):58-66. doi: 10.1016/j.psyneuen.2012.04.020. Epub 2012 May 22.
- Background Brunoni AR, Valiengo L, Baccaro A, Zanao TA, de Oliveira JF, Goulart A, Boggio PS, Lotufo PA, Bensenor IM, Fregni F. The sertraline vs. electrical current therapy for treating depression clinical study: results from a factorial, randomized, controlled trial. JAMA Psychiatry. 2013 Apr;70(4):383-91. doi: 10.1001/2013.jamapsychiatry.32.
- Background Brunoni AR, Moffa AH, Fregni F, Palm U, Padberg F, Blumberger DM, Daskalakis ZJ, Bennabi D, Haffen E, Alonzo A, Loo CK. Transcranial direct current stimulation for acute major depressive episodes: meta-analysis of individual patient data. Br J Psychiatry. 2016 Jun;208(6):522-31. doi: 10.1192/bjp.bp.115.164715. Epub 2016 Apr 7.
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- Background Chhatbar PY, Kautz SA, Takacs I, Rowland NC, Revuelta GJ, George MS, Bikson M, Feng W. Evidence of transcranial direct current stimulation-generated electric fields at subthalamic level in human brain in vivo. Brain Stimul. 2018 Jul-Aug;11(4):727-733. doi: 10.1016/j.brs.2018.03.006. Epub 2018 Mar 13.
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- Background Cosmo C, Baptista AF, de Araujo AN, do Rosario RS, Miranda JG, Montoya P, de Sena EP. A Randomized, Double-Blind, Sham-Controlled Trial of Transcranial Direct Current Stimulation in Attention-Deficit/Hyperactivity Disorder. PLoS One. 2015 Aug 12;10(8):e0135371. doi: 10.1371/journal.pone.0135371. eCollection 2015.
- Background Costanzo F, Menghini D, Casula L, Amendola A, Mazzone L, Valeri G, Vicari S. Transcranial Direct Current Stimulation Treatment in an Adolescent with Autism and Drug-Resistant Catatonia. Brain Stimul. 2015 Nov-Dec;8(6):1233-5. doi: 10.1016/j.brs.2015.08.009. Epub 2015 Aug 24. No abstract available.
- Background Costanzo F, Varuzza C, Rossi S, Sdoia S, Varvara P, Oliveri M, Giacomo K, Vicari S, Menghini D. Evidence for reading improvement following tDCS treatment in children and adolescents with Dyslexia. Restor Neurol Neurosci. 2016;34(2):215-26. doi: 10.3233/RNN-150561.
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- Background Dichter GS, Gibbs D, Smoski MJ. A systematic review of relations between resting-state functional-MRI and treatment response in major depressive disorder. J Affect Disord. 2015 Feb 1;172:8-17. doi: 10.1016/j.jad.2014.09.028. Epub 2014 Sep 26.
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- Background East, M. and Surveillance, G. (2020) 'Home care for patients with COVID-19 presenting with mild symptoms and management of their contacts', (March), pp. 17-20. Available at: https://www.who.int/publications-detail/home-care-for-patients-with-suspected-novel-coronavirus-(ncov)-infection-presenting-with-mild-symptoms-and-management-of-contacts (Accessed: 3 April 2020).
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- Results Jiang N, Wei J, Li G, Wei B, Zhu FF, Hu Y. Effect of dry-electrode-based transcranial direct current stimulation on chronic low back pain and low back muscle activities: A double-blind sham-controlled study. Restor Neurol Neurosci. 2020;38(1):41-54. doi: 10.3233/RNN-190922.
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Fluoxetine | Small molecule | 20 mg | — |