Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

TDCS in Pediatric and Teenage Patients With Major Depressive Disorder During COVID-19 Pandemic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04780152
Recruitment Status : Recruiting
First Posted : March 3, 2021
Last Update Posted : March 8, 2021
Sponsor:
Collaborator:
Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico
Information provided by (Responsible Party):
DANIEL SAN JUAN ORTA, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Brief 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: Transcranial Direct Current Stimulation Device: Placebo-simulation of transcranial direct current stimulation Drug: Fluoxetine Tablets Phase 2 Phase 3

Detailed Description:
After being widely informed about the study and potential risks, all the patients giving voluntary informed consent will be randomized in a 1:1 ratio to a tDCS group (a-tDCS+ standard treatment) or control group (placebo-simulations a-tDCS+ standard treatment).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A multicentric, randomized, clinical trial, phase 2/3 of superiority, with two parallel arms, comparative, controlled with placebo, in which changes in a major depressive disorder scale will be assessed (change in CDI score measured at week 10 compared with initial score) comparing with basal score and between the two groups (>40% measured at 2 weeks, 1,2, 3 months of treatment).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: In addition some of the personnel (evaluators, data analyst, result analyst) will be blinded in order to increase the internal validity of our study. A blind person is considered by the person that apply the intervention.
Primary Purpose: Treatment
Official Title: Assessment of Efficacy and Safety of Anodal Transcranial Direct Current Stimulation (TDCS) in Pediatric and Teenage Patients With Major Depressive Disorder During COVID-19 Pandemics
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

Arm Intervention/treatment
Experimental: tDCS arm
Participants receive 10 consecutive sessions followed by 1 session per week 10 weeks of tDCS (30 minutes and 2 mA) + fluoxetine (10 mg daily 2 weeks followed by 20 mg daily).
Device: Transcranial Direct Current Stimulation
Participants receive 10 consecutive sessions followed by 1 session per week 10 weeks of tDCS (30 minutes and 2 mA). Anodal stimulation will be applied on F3 according to the intentional 10/20 system, and the cathode will be applied on the contra lateral position (F4).
Other Names:
  • TDCS
  • Anodal electric transcranial direct current stimulation

Drug: Fluoxetine Tablets
Every patient will receive 10 mg of fluoxetine daily the first 2 two weeks, followed by 20 mg daily.
Other Name: Antidepressants

Placebo Comparator: Control arm
Participant receive 10 consecutive sessions followed by 1 session per week 10 weeks of placebo (30 minutes of placebo-simulation tDCS) + fluoxetine (10 mg daily 2 weeks followed by 20 mg daily).
Device: Placebo-simulation of transcranial direct current stimulation
Participants receive 10 consecutive sessions followed by 1 session per week 10 weeks of placebo (30 minutes of placebo-simulation tDCS). Placebo will be administered using the same stimulation parameters and the active treatment position of the electrodes, but current wil be aborted 30 seconds after the ascending slope has begun.

Drug: Fluoxetine Tablets
Every patient will receive 10 mg of fluoxetine daily the first 2 two weeks, followed by 20 mg daily.
Other Name: Antidepressants




Primary Outcome Measures :
  1. Change of Children Depression Inventory score from the beginning to the end of the study [ Time Frame: At the beginning of the study and at the end of weeks 2, 4, 8, and 12 ]
    It is one of the most widely used self-applied scales to assess depressive symptoms in children and teenagers. The scale consists of 27 items, each item with 3 response options, where 0= absence of symptoms, 1= moderate symptoms, and 2= severe symptoms. The total score ranges from 0-54. The scale manual contains the psychometric properties reported by the author. It is recommended for use in children from 7-17 years old. a SCORE OF 20 was established as a cut-off point for indicating depression problems


Secondary Outcome Measures :
  1. Change of Columbia-Suicide Severity Rating Scale score from the beginning to the end of the study [ Time Frame: At the beginning of the study and at the end of weeks 2, 4, 8, and 12 ]
    The C-SSRS is a semi-structured interview which collects the onset, severity and frequency of behavior and thoughts related to suicide during the assessement period. Therefore, 4 constructs are measured.

  2. Change of Young Mania Rating Scale score from the begining to the end of the study [ Time Frame: At the beginning of the study and at the end of weeks 2, 4, 8, and 12 ]

    It is an instrument for quantifying mania symptoms that consist of 11 items, each one with 5 response options, which reflect higher score if great intensity. It is applied by the clinician and is based on the subjective report of the patient during 48 hrs prior to the evaluation, as well as on the observation of the patient's behavior during the interview. The patient selects the intensity level of the symptom for each item with an option from 0 to 4.

    The total range of the scale from 0-60 points where higher scores indicate a greater degree of manic characteristics; the minimum score to define new-onset mania or hypomania is 8 points at the end of the weeks 2, 4, 8 and 12 to assess mania or hypomania during the clinical trial.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major Depressive Disorder (MDD) diagnosed through the clinical interview based on the Affective Disorders and Schizophrenia Agenda for schoolchildren-current version and for life K- SADS-PL for its acronym in English, with a single or recurrent episode lasting ≥4 weeks.
  • The current depressive episode must have a duration of less than 5 years and be at least greater than 2 months in which the patient meets the operational definition of MDD from the DSM-V.
  • CID scale with values equal to 17 or higher in the clinical evaluation.
  • No use of another medication during the intervention days.
  • They should not be taking antidepressants at the beginning of the study (last 4 weeks) or it must have passed the adequate time of "washing"/ clearance of antidepressant drugs established as 5 or more biological half-lifes or 5 days before the randomization.
  • To be able and willing to give their informed consent, both, the parent or tutor and the participant who is between the ages of 14-17 years. In the age group of 10-13 years the assent of the patient and the consent of the parent or tutor.
  • Use of benzodiazepines (eg lorazepam) equivalent to 20 mg of diazepam and which remains stable during the study.
  • Patients with an unchanged drug treatment for MDD in the last 4 weeks and who agree to switch the fluoxetine at the time of randomization, meeting the previously described antidepressant criteria.

Exclusion Criteria:

  • Previous skull surgery.
  • Recent skull injury (6 months).
  • Use of central nervous system stimulants.
  • Respiratory System infections.
  • Does NOT sign or is unable to sign informed consent or legal tutors/parents do not consent.
  • Clinical condition or anomaly, which in the researcher's opinion, compromises patient´s safety or data quality.
  • Uncontrolled co-existent medical condition, progressive cerebral disorder, severe systemic diseases, symptomatic disease, cardiac disease, skin chronic diseases or damaged scalp which could interfere with tDCS stimulation.
  • Any skull metal implant (excluding dental filling or titanium plates) or medical devices (cardiac pacemaker, deep cerebral stimulator, drug infusion pump, cochlear implant, vagus nerve stimulator).
  • Direct researcher relatives or personnel directly involved in the study.
  • Acute suicide risk measured through the Montgomery Asberg depression rating scale (MADRS) >4 points or positivity of the 4th or 5th item of The Columbia Suicide Severity Rating Scale (C-SSRS).
  • Depression resistant to treatment with >4 well indicated drugs during the current episode.
  • Bipolar disorder history or current mania symptoms.
  • Treatment with electroshock therapy concomitantly and during the last 12 months.
  • Other relevant psychiatric disorders according to the DSM 5 (except generalized anxiety disorder, specific phobia or separation anxiety disorder).
  • Previous treatment with tDCS for a different disease to the major depressive disorder.
  • Intellectual development disorder previously documented or clinical evaluation fulfilling the CIE-F79 criteria.
  • Due to the fact that treatment with tDCS has counter-indications, will be excluded: those with history of non provoked seizures, convulsive disorders, history of febrile seizure, family history of epilepsy or brain tumor, pregnancy.
  • Counter-indication or history of adverse reactions from mild to severe to fluoxetine.

Elimination criteria:

  • Patients that do not complete the neuropsychological assessment tests.
  • Interruption of the intervention of less than 50% of what was scheduled.
  • Onset of active suicidal ideation.
  • Active psychosis.
  • Start of emerging mania treatment.
  • Pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780152


Contacts
Layout table for location contacts
Contact: Daniel San Juan, M.D. (55)56063822 ext 2527 pegaso31@yahoo.com
Contact: Angel R Chow, M.D (55)56063822 ext 1033 aaruizchow@gmail.com

Locations
Layout table for location information
Mexico
Instituto Nacional de Neurología y Neurocirugía Recruiting
Mexico City, Ciudad De México, Mexico, 14269
Contact: Daniel San-Juan, MD    525556063822 ext 2527    pegaso31@yahoo.com   
Contact: Angel R. Chow, MD    525556063822 ext 1033    aaruizchow@gmail.com   
Principal Investigator: Daniel San-Juan, MD         
Sponsors and Collaborators
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico
Publications of Results:

Other Publications:
(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: nfo@cempro.org.mx (reproducci? prohibida) (Accessed: 11 May 2020).
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.
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
CDC COVID-19 Response Team (2020) 'Morbidity and mortality weekly report (mmwr) - Coronavirus Disease 2019 in Children - United States, February 12-April 2, 2020', Morbidity and Mortality Weekly Report, 69, pp. 2-6. Available at: https://www.cdc.gov/coronavirus/2019-ncov/downloads/pui-form.pdf.
CDI. Inventario de Depresión Infantil (no date). Available at: http://web.teaediciones.com/CDI--INVENTARIO-DE-DEPRESION-INFANTIL.aspx (Accessed: 13 September 2020).
Cofré, F. et al. (2017) 'Guía Clínica', Rev Chil Obstet Ginecol, 82(2), pp. 83-123. Available at: http://www.revistasochog.cl/files/pdf/GC_010.pdf (Accessed: 24 April 2020).
Depression and Other Common Mental Disorders: Global Health Estimates. Geneva: World Health Organization; 2017. Licence: CC BY-NC-SA 3.0 IGO (2017).
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).
'ESTADÍSTICAS A PROPÓSITO DEL DÍA MUNDIAL PARA LA PREVENCIÓN DEL SUICIDIO (10 DE SEPTIEMBRE)' DATOS NACIONALES (no date). Available at: http://www.who.int/mediacentre/news/releases/2004/pr61/es/, (Accessed: 20 June 2020).
Fang, Y. (2019) Depressive Disorders: Mechanisms, Measurement and Management, Depressive Disorders: Mechanisms, Measurement and Management. doi: 10.1007/978-981-32-9271-0.
FDA greenlights Neuroelectrics to help patients with Major Depression at home amidst Covid-19 restrictions - Neuroelectrics Blog - Latest news about EEG & Brain Stimulation (no date). Available at:https://www.neuroelectrics.com/blog/2020/05/15/fda-greenlights-neuroelectrics-to-treat-patients-with-major-depression-at-home/ (Accessed: 8 July 2020).
Hedden, S. L. et al. (no date) Key Substance Use and Mental Health Indicators in the United States: Results from the 2015 National Survey on Drug Use and Health. Available at: http://www.samhsa.gov/data/ (Accessed: 26 April 2020).
Hidalgo Vicario, M. H. and Rodríguez Hernández, P. R. (2013) DSM-5. manual diagnóstico y estadístico de los trastornos mentales. últimas novedades, Pediatria Integral.
Horvath, J. C., Najib, U. and Press, D. (2014) 'Transcranial magnetic stimulation (TMS) clinical applications: Therapeutics', Neuromethods. Humana Press Inc., 89, pp. 235-257. doi: 10.1007/978-1-4939-0879-0_12.
INEGI COMUNICADO DE PRENSA NUM. 455/19 10 DE SEPTIEMBRE DE 2019 PÁGINA 1/9 - Buscar con Google (no date). Available at: https://www.google.com/search?sxsrf=ALeKk01JBW760RYZRSJRSP54SHpa-UGe8Q%3A1592707941359&ei=ZcvuXp63FdiFtQbCzo_oAg&q=INEGI+COMUNICADO+DE+PRENSA+NUM.+455%2F19+10+DE+SEPTIEMBRE+DE+2019+PÁGINA+1%2F9&oq=INEGI+COMUNICADO+DE+PRENSA+NUM.+455%2F19+10+DE+SEPTIEMBRE+DE+2019+PÁGINA+1%2F9&gs_lcp=CgZwc3ktYWIQAzIECAAQRzIECAAQRzIECAAQRzIECAAQRzIECAAQRzIECAAQRzIECAAQRzIECAAQR1AAWABgnBhoAHABeACAAQCIAQCSAQCYAQCqAQdnd3Mtd2l6&sclient=psy-ab&ved=0ahUKEwje_cy485HqAhXYQs0KHULnAy0Q4dUDCAw&uact=5 (Accessed: 20 June 2020).
Marcela Cárdenas Miriam Feria Lino Palacios Francisco de la Peña GUÍAS, E. et al. (2010) CLÍNICAS PARA LA ATENCIÓN DE TRASTORNOS MENTALES Guía clínica para los trastornos de ansiedad en niños y adolescentes, Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz. Available at: https://s3.amazonaws.com/academia.edu.documents/40579737/trastornos_de_ansiedad.pdf?AWSAc cessKeyId=AKIAIWOWYYGZ2Y53UL3A&Expires=1524569155&Signature=VyM4VFWuFjyCkOY4Ml 7rnE2WN10%3D&response-content-disposition=inline%3B filename%3DTrastornos_de_ansiedad. (Accessed: 14 April 2020).
Rey, Joseph M; Bella-Awusah, Tolulope T; Liu, J. (2017) 'Depresión E.1 Manual de Salud Mental Infantil y Adolescente de la IACAPAP de la Sociedad Asiática de Psiquiatría Infantil y Adolescente y Profesionales Afines Conflictos de interés: No se declaran', pp. 1-41.
Tamayo, J. M. et al. (2011) Definición e impacto de las depresiones resistentes/refractarias al tratamiento, Actualización por temas Salud Mental.
Tochoy, P. P. and Chaskel, R. (no date) 'Depresión en niños y adolescentes', pp. 30-38.
Ulloa-Flores, R. E. and De La Peña-Olvera, F. (2011) Tratamiento multimodal de niños y adolescentes con depresión, Artículo original Salud Mental.
World Health Organization (2020a) Situation Report-75 HIGHLIGHTS. Available at: https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200404-sitrep-75-covid- 19.pdf?sfvrsn=99251b2b_2 (Accessed: 4 April 2020).
World Health Organization (2020b) WHO Director-General ' s remarks at the media briefing on 2019-nCoV on 11 February. Available at: https://www.who.int/dg/speeches/detail/who-director-general- s-remarks-at-the-media-briefing-on-2019-ncov-on-11-february-2020 (Accessed: 2 April 2020).
World Health Organization, W. (2020a) Situation Report-83 HIGHLIGHTS. Available at: https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200412-sitrep-83-covid- 19.pdf?sfvrsn=697ce98d_4 (Accessed: 12 April 2020).
World Health Organization, W. (2020b) WHO Director-General's opening remarks at the media briefing on COVID-19 - 11 March 2020, WHO Director General's speeches. Available at: https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media- briefing-on-covid-19---3-march-2020 (Accessed: 2 April 2020).

Layout table for additonal information
Responsible Party: DANIEL SAN JUAN ORTA, Master in Clinical Research, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
ClinicalTrials.gov Identifier: NCT04780152    
Other Study ID Numbers: 54/20
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 8, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Personal data information will remain with strictly confidential character in the research center. However, personal data will be examined by all individuals related to the research project and/or those selected for its analysis, including representatives of Mexican health authorities and other regulatory agencies with inspection purposes.

If the data obtained through this study is published, the report will be written in a way no person could identify their personal data or identity, unless such information is officially required by any mexican or foreign authority.


Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by DANIEL SAN JUAN ORTA, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez:
TDCS
Pediatrics
COVID-19
Adolescents
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Fluoxetine
Antidepressive Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors