Finding a Biomarker for Acute Neuromodulation Effects in Adolescent Depression

April 14, 2023 updated by: Dr. Peter Giacobbe, Sunnybrook Health Sciences Centre

Finding a Biomarker for Acute Neuromodulation Effects in Adolescent Depression: A Pilot Study

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Sham Stimulation
15 Depressed adolescents will undergo emotional processing tasks (within and outside the fMRI scanner) after one session of sham 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.
Active Comparator: Active Stimulation
15 Depressed adolescents will undergo emotional processing tasks (within and outside the fMRI scanner) after one session of active rTMS
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment rates
Time Frame: 2 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
estimating the magnitude of difference detectable in cortico-limbic activity between groups
Time Frame: 2 years
How many sessions of rTMS is sufficient to produce changes in emotional processing and associated cortico-limbic activity.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunnybrook Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5439

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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