Recruiting

Biomarker for Neuromodulation

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT05832294

Conditions

Recruitment

Eligibility Criteria

Sex: All

Age: 14 - 21

Healthy Volunteers: Not accepted

Interventions

Treatment rTMS

Sham rTMS

Study Details

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

Study ID

NCT05832294

Start date

Apr 20, 2023

Status verified date

Apr, 2023

Completion date

Jan 1, 2025

Anticipated

Primary completion date

Jan 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Female or male patients between ages 14-21
2. Diagnosis of major depressive disorder as defined by the Diagnostic and Statistical Manual fifth edition (DSM-5)
3. Hamilton Rating Scale for Depression (17-item) score of at least 20
4. At least one failed adequate antidepressant trial
5. 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
6. Ability to provide informed consent and comply with all testing, follow-ups and study appointments and protocols

Exclusion Criteria:

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Sham Stimulation

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

active comparator: Active Stimulation

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

Interventions

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.

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.

Primary outcome measure

  • Recruitment rates [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Enoch Ng

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

Anusha Baskaran

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

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Enoch Ng, MD

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

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Apr 27, 2023

Last verified

Apr, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2023-04-27.