Finding a Biomarker for Acute Neuromodulation Effects in Adolescent Depression

NCT05832294 | Unknown

• 1 other identifier: 5439
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study aims to examine the feasibility of recruiting depressed adolescents to examine changes in emotional processing and in neural responses to emotional stimuli after one session of rTMS (which is followed by an open-label phase of 4 weeks active rTMS).

Conditions

Recruitment

Outcome Measures

Primary Outcomes (1)

• Recruitment rates

  What is the sufficient time to recruit depressed adolescents from Sunnybrook Health Sciences Centre who provide informed consent for a study examining the effects of one-session rTMS on brain function as measured by fMRI

  2 years

Secondary Outcomes (1)

• estimating the magnitude of difference detectable in cortico-limbic activity between groups

  2 years

Study Arms (2)

Sham Stimulation

SHAM COMPARATOR

15 Depressed adolescents will undergo emotional processing tasks (within and outside the fMRI scanner) after one session of sham rTMS

Device: Sham rTMS

Active Stimulation

ACTIVE COMPARATOR

15 Depressed adolescents will undergo emotional processing tasks (within and outside the fMRI scanner) after one session of active rTMS

Device: Treatment rTMS

Interventions

Treatment rTMS DEVICE

Depressed adolescents will undergo emotional processing tasks (within and outside the fMRI scanner) after one session of 1) sham rTMS (n = 15) or 2) active rTMS (n = 15). Prior to stimulation, expectancy for symptomatic benefit will be assessed with a standardized scale and a semi-structured interview conducted regarding their perception of rTMS. After the one-day randomized controlled phase, participants can then enter an open-label active rTMS treatment phase for 4 weeks. Eligible patients who decline the study and open-label treatment phase will be invited to participate in a semi-structured interview to explore their perceptions toward rTMS.

Active Stimulation

Sham rTMS DEVICE

Depressed adolescents will undergo emotional processing tasks (within and outside the fMRI scanner) after one session of 1) sham rTMS (n = 15) or 2) active rTMS (n = 15). Prior to stimulation, expectancy for symptomatic benefit will be assessed with a standardized scale and a semi-structured interview conducted regarding their perception of rTMS. After the one-day randomized controlled phase, participants can then enter an open-label active rTMS treatment phase for 4 weeks. Eligible patients who decline the study and open-label treatment phase will be invited to participate in a semi-structured interview to explore their perceptions toward rTMS.

Sham Stimulation

Eligibility Criteria

• Age: 14 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female or male patients between ages 14-21
• Diagnosis of major depressive disorder as defined by the Diagnostic and Statistical Manual fifth edition (DSM-5)
• Hamilton Rating Scale for Depression (17-item) score of at least 20
• At least one failed adequate antidepressant trial
• On a stable antidepressant regimen for at least 4 weeks before treatment which can continue during treatment and agreement to not make changes or additions to psychotropic medications during the course of their participation in the study
• Ability to provide informed consent and comply with all testing, follow-ups and study appointments and protocols

You may not qualify if:

• Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, delusional disorder, post-traumatic stress disorder, obsessive compulsive disorder, autism spectrum disorder
• Active neurologic disease
• Any lifetime history of seizures
• Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine
• Current active suicidal ideation
• Personality disorder deemed to be the primary pathology
• Taking more than 2 mg lorazepam (or an equivalent) or any anticonvulsant
• Previous rTMS treatment

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Central Study Contacts

Enoch Ng

CONTACT

416-480-6100; enoch.ng@sunnybrook.ca

Anusha Baskaran

CONTACT

416-480-6100; anusha.baskaran@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blinded sham-controlled between-subjects design with two arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Head, Associate Scientist

Model Details: Single-blinded sham-controlled between-subjects design with two arms.

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: April 27, 2023
• Study Start: April 20, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)