Finding a Biomarker for Acute Neuromodulation Effects in Adolescent Depression

Phase

N/A

Condition

Depression

Treatment

N/A

Clinical Study ID

NCT05832294

5439

Ages 14-21
All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

Female or male patients between ages 14-21
Diagnosis of major depressive disorder as defined by the Diagnostic and StatisticalManual 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 cancontinue during treatment and agreement to not make changes or additions topsychotropic medications during the course of their participation in the study
Ability to provide informed consent and comply with all testing, follow-ups and studyappointments and protocols

Exclusion

Exclusion Criteria:

Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffectivedisorder, delusional disorder, post-traumatic stress disorder, obsessive compulsivedisorder, autism spectrum disorder
Active neurologic disease
Any lifetime history of seizures
Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine andnicotine
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

Study Design

April 20, 2023

January 01, 2025

Study Description

Repetitive transcranial magnetic stimulation (rTMS) is a promising treatment for adolescent depression but clinical trials have been hampered by a lack of dose optimization studies and high placebo rates. While rTMS does not produce mood changes until after weeks of treatment, unconscious changes in emotional processing have been found even after one session of stimulation. It is unknown whether one session of rTMS produces changes in neural activity to emotional stimuli in depressed adolescents. If acute rTMS can reliably produce changes in neural activity associated with emotional processing it could be a biomarker to aid future dose-finding studies. A one-session protocol allows experimenters to truthfully reduce expectancy of mood change and reduce placebo effects. This study will examine the feasibility of recruitment and using a one-session protocol to find a biomarker for acute rTMS effects. A single-blinded sham-controlled design will be used. Depressed adolescents will undergo: 1) sham stimulation (n=15) or 2) active stimulation with intermittent theta burst stimulation (iTBS) (n=15) for one session prior to assessment of brain activity in response to emotional stimuli in a fMRI and other emotional processing tasks. This one day randomized controlled phase can then lead into an open-label treatment phase active rTMS for 4 weeks. The primary outcome will be recruitment rates with a secondary outcome of estimating the magnitude of difference detectable in cortico-limbic activity between groups. This study assesses the feasibility of a novel paradigm to help improve clinical trials for neuromodulation in depressed adolescents.

Connect with a study center

Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5
Canada
Active - Recruiting

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