Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05832294
Other study ID # 5439
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 20, 2023
Est. completion date January 1, 2025

Study information

Verified date April 2023
Source Sunnybrook Health Sciences Centre
Contact Enoch Ng
Phone 416-480-6100
Email enoch.ng@sunnybrook.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date January 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 14 Years to 21 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Canada Sunnybrook Health Sciences Centre Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 estimating the magnitude of difference detectable in cortico-limbic activity between groups How many sessions of rTMS is sufficient to produce changes in emotional processing and associated cortico-limbic activity. 2 years
See also
  Status Clinical Trial Phase
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT03036696 - The BEACH Interview Study- Pregnant and Breastfeeding Mothers
Completed NCT04082377 - Effects of Two Different Stepwise Lung Recruitment Maneuvers on Patient Hemodynamics During Laproscopic Surgery N/A
Terminated NCT00674037 - Efficacy of Monetary Incentives for Primary Care Physicians on Patients N/A
Not yet recruiting NCT03682341 - Oxidative Stress Gene Polymorphism and Ovarian Reserve Functione
Completed NCT06049056 - Which Automated Methodology?
Withdrawn NCT05631418 - Chinese Regional Spinal Muscular Atrophy Patient Registration Study
Completed NCT04650906 - A Feasibility Study for Evaluating the Effectiveness of Mindhelper - a National Youth Mental Health Promotion Website N/A
Recruiting NCT06347484 - Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT) N/A
Recruiting NCT03069586 - Effect Low Pressure Pneumoperitoneum and Pulmonary Recruitment on Postoperative Pain N/A
Recruiting NCT05248243 - Recruitment Assessment in Patients With Acute Respiratory Distress Syndrome and Covid-19
Not yet recruiting NCT04264429 - Effect of the Infrapatellar Strap and Elastic Band Iin Athletes With Patellofemoral Pain Syndrome N/A
Completed NCT01457651 - Comparison of Four Different Recruitment Maneuvers in Patients After Coronary Surgery N/A
Completed NCT04258202 - Ventilator-driven Alveolar Recruitment Maneuver N/A
Completed NCT01626326 - San Francisco Stop Smoking App - Pilot Study
Completed NCT04914819 - Postpartum Weight Loss for Women at Elevated Cardiovascular Risk N/A
Not yet recruiting NCT03431636 - Effect of Different Techniques of Recovery in Para-athletes N/A
Recruiting NCT05780164 - Improving Access to Lung Cancer Clinical Trials
Not yet recruiting NCT03029065 - Detection of CSF Next Generation Sequencing in the Application of Brain Metastases From Lung Adenocarcinoma or Meningeal Metastasis N/A
Recruiting NCT01294813 - Bronchoscopy and Electric Impedance Tomography (EIT) Pilot Study N/A