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

NCT ID: NCT04780152

Last Updated: 2021-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-31
• Study Completion Date: 2022-09-30

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.

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).

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type: DEVICE

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).

Fluoxetine Tablets

Intervention Type: DRUG

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

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).

Group Type: PLACEBO_COMPARATOR

Placebo-simulation of transcranial direct current stimulation

Intervention Type: DEVICE

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 Tablets

Intervention Type: DRUG

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

Interventions

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).

Intervention Type: 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.

Intervention Type: DEVICE

Fluoxetine Tablets

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

Intervention Type: DRUG

Other Intervention Names

TDCS; Anodal electric transcranial direct current stimulation; Antidepressants

Eligibility 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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico

OTHER_GOV

Sponsor Role: collaborator

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

OTHER

Sponsor Role: lead

Responsible Party

DANIEL SAN JUAN ORTA

Master in Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Instituto Nacional de Neurología y Neurocirugía

Mexico City, Mexico City, Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Daniel San Juan, M.D.

Role: CONTACT

pegaso31@yahoo.com

(55)56063822 ext. 2527

Angel R Chow, M.D

Role: CONTACT

aaruizchow@gmail.com

(55)56063822 ext. 1033

Facility Contacts

Daniel San-Juan, MD

Role: primary

pegaso31@yahoo.com

525556063822 ext. 2527

Angel R. Chow, MD

Role: backup

aaruizchow@gmail.com

525556063822 ext. 1033

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Other Identifiers

54/20

Identifier Type: -

Identifier Source: org_study_id