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Finding a Biomarker for Acute Neuromodulation Effects in Adolescent Depression

NCT05832294 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-04-27

No results posted yet for this 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).

Conditions

  • Recruitment

Interventions

DEVICE

Treatment rTMS

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.

DEVICE

Sham rTMS

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.

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-20
Primary Completion
2025-01-01
Completion
2025-01-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05832294 on ClinicalTrials.gov