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Major Depressive DisorderPhase 2/3NCT04780152

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

A Phase 2/3 study testing Transcranial Direct Current Stimulation and Fluoxetine Tablets in people with Major Depressive Disorder, run by El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 17 years
Conditions the study is for
Major Depressive Disorder
What is being tested?
Transcranial Direct Current Stimulation and Fluoxetine Tablets
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
172 participants
Where
1 siteMexico
Study dates
Oct 2021to Sep 2022
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 25Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Daniel San Juan, M.D. contact

(55)56063822 ext. 2527

pegaso31@yahoo.com

Angel R Chow, M.D contact

(55)56063822 ext. 1033

aaruizchow@gmail.com

Mexico1 site, 1 recruiting

  • Instituto Nacional de Neurología y Neurocirugía

    Mexico City, Mexico City, 14269

    Daniel San-Juan, MD, 525556063822 ext. 2527, pegaso31@yahoo.com

    Angel R. Chow, MD, 525556063822 ext. 1033, aaruizchow@gmail.com

    Recruiting

Other trials in Mexico

About this study

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

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.

Read the 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).

Being tested
Transcranial Direct Current Stimulation, Placebo-simulation of transcranial direct current stimulation, Fluoxetine Tablets
Keywords
TDCS, Pediatrics, COVID-19, Adolescents
Medical subject headings
Depressive Disorder, Major, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial Direct Current StimulationDevice

    Also called TDCS, Anodal electric 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).

  • Placebo-simulation of transcranial direct current stimulationDevice

    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.

  • Fluoxetine TabletsDrug

    Also called Antidepressants

    Every patient will receive 10 mg of fluoxetine daily the first 2 two weeks, followed by 20 mg daily.

Study groups in NCT04780152
Study groupRoleWhat they receive
tDCS armExperimentalParticipants 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).
Receives: Device: Transcranial Direct Current Stimulation; Drug: Fluoxetine Tablets
Control armPlacebo comparatorParticipant 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).
Receives: Device: Placebo-simulation of transcranial direct current stimulation; Drug: Fluoxetine Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Children Depression Inventory score from the beginning to the end of the study

    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

    Measured: At the beginning of the study and at the end of weeks 2, 4, 8, and 12

Secondary outcomes (2)

  1. Change of Columbia-Suicide Severity Rating Scale score from the beginning to the end of the study

    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.

    Measured: At the beginning of the study and at the end of weeks 2, 4, 8, and 12

  2. Change of Young Mania Rating Scale score from the begining to the end of the study

    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.

    Measured: At the beginning of the study and at the end of weeks 2, 4, 8, and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2021
  2. Study startOct 2021 (estimated)
  3. Primary completionAug 2022 (estimated)
  4. Study completionSep 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
172 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04780152
Sponsor's protocol ID
54/20
Status last verified
Jun 2021
First submitted
2 Mar 2021
Last updated
4 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

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).

  • Abdallah CG, Sanacora G, Duman RS, Krystal JH. The neurobiology of depression, ketamine and rapid-acting antidepressants: Is it glutamate inhibition or activation? Pharmacol Ther. 2018 Oct;190:148-158. doi: 10.1016/j.pharmthera.2018.05.010. Epub 2018 May 25.

    PubMed 29803629

  • 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.

  • 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.

    PubMed 27158026

  • 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

  • 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.

    PubMed 31005790

  • 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.

    PubMed 16037080

  • 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.

    PubMed 26879095

  • 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.

    PubMed 23339180

  • Belleau EL, Treadway MT, Pizzagalli DA. The Impact of Stress and Major Depressive Disorder on Hippocampal and Medial Prefrontal Cortex Morphology. Biol Psychiatry. 2019 Mar 15;85(6):443-453. doi: 10.1016/j.biopsych.2018.09.031. Epub 2018 Oct 10.

    PubMed 30470559

  • Bernaras E, Jaureguizar J, Garaigordobil M. Child and Adolescent Depression: A Review of Theories, Evaluation Instruments, Prevention Programs, and Treatments. Front Psychol. 2019 Mar 20;10:543. doi: 10.3389/fpsyg.2019.00543. eCollection 2019.

    PubMed 30949092

  • Bikson M, Esmaeilpour Z, Adair D, Kronberg G, Tyler WJ, Antal A, Datta A, Sabel BA, Nitsche MA, Loo C, Edwards D, Ekhtiari H, Knotkova H, Woods AJ, Hampstead BM, Badran BW, Peterchev AV. Transcranial electrical stimulation nomenclature. Brain Stimul. 2019 Nov-Dec;12(6):1349-1366. doi: 10.1016/j.brs.2019.07.010. Epub 2019 Jul 17.

    PubMed 31358456

  • Birmaher B, Ryan ND, Williamson DE, Brent DA, Kaufman J, Dahl RE, Perel J, Nelson B. Childhood and adolescent depression: a review of the past 10 years. Part I. J Am Acad Child Adolesc Psychiatry. 1996 Nov;35(11):1427-39. doi: 10.1097/00004583-199611000-00011.

    PubMed 8936909

  • Bobo WV, Shelton RC. Fluoxetine and olanzapine combination therapy in treatment-resistant major depression: review of efficacy and safety data. Expert Opin Pharmacother. 2009 Sep;10(13):2145-59. doi: 10.1517/14656560903130609.

    PubMed 19640209

  • Bora E, Fornito A, Pantelis C, Yucel M. Gray matter abnormalities in Major Depressive Disorder: a meta-analysis of voxel based morphometry studies. J Affect Disord. 2012 Apr;138(1-2):9-18. doi: 10.1016/j.jad.2011.03.049. Epub 2011 Apr 20.

    PubMed 21511342

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Transcranial Direct Current Stimulation and Fluoxetine Tablets in people with Major Depressive Disorder, run by El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Daniel San Juan, M.D. ((55)56063822 ext. 2527, pegaso31@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04780152, which also lists 142 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021.

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