NCT02472470

Brief Summary

Youth depression is a debilitating disorder that exacts enormous social, economic and personal cost. Unfortunately, treatments which are conventionally used to treat adult depression have often modest to no efficacy in youth and have side effects. Thus, there is a tremendous imperative to develop new treatments for youth depression. Investigators propose to examine the efficacy of a short form of repetitive transcranial magnetic stimulation (rTMS) for youth depression and examine its biological targets. This will be the first study examining the efficacy of a short rTMS protocol in youth diagnosed with depression who fail responding to or are intolerable to antidepressants. If the results are positive, investigators will have identified a novel treatment that may be both more efficacious, better tolerated and more acceptable treatment for youth depression. Finally, identifying the biological mechanisms leading to treatment efficacy will lead to more personalized treatments for youth depression and will be groundbreaking vis à vis understanding the mechanisms involved in this illness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

October 24, 2017

Status Verified

October 1, 2017

Enrollment Period

1.9 years

First QC Date

June 10, 2015

Last Update Submit

October 22, 2017

Conditions

Depressive Symptoms

Keywords

rTMSDepressionYouthTBSBrain StimulationElectrophysiologyImaging

Outcome Measures

Primary Outcomes (1)

  • Depressive Symptoms as Measured by HRSD-17

    Outcome measure is measured by a change in the HRSD-17 score from baseline to week 1 and week 3. A 50% improvement in the score is considered response to rTMS

    Baseline (before treatment trial starts), week 1 (after 5 days of treatment), and week 3 (within a week after the end of the 2-week treatment trial)

Secondary Outcomes (2)

  • Beck Depression Inventory-II (BDI-II)

    Baseline (before treatment trial starts), week 1 (after 5 days of treatment), and week 3 (within a week after the end of the 2-week treatment trial)

  • Children's Depression Rating Scale, revised-version (CDRS-R)

    Baseline (before treatment trial starts), week 1 (after 5 days of treatment), and week 3 (within a week after the end of the 2-week treatment trial)

Study Arms (1)

Treatment

EXPERIMENTAL

intermitten TBS (iTBS) rTMS applied to the left Dorsolateral Prefrontal Cortex (DLPFC) + continuous TBS (cTBS) rTMS applied to the right DLPFC. The order will be counterbalanced. Administration of this treatment takes roughly 10 minutes. This treatment will be applied daily, 5 days/week, for 2 weeks.

Device: rTMS

Interventions

rTMSDEVICE

Participants will receive 10 active TBS rTMS sessions once daily on weekdays for 2 weeks.

Also known as: TBS
Treatment

Eligibility Criteria

Age16 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • outpatients
  • between the ages of 16 and 24
  • competent to consent to study participation
  • Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of MDD single or recurrent
  • no change in treatment (psychotherapy or medication) for at least four weeks prior to participation in the study
  • HRSD-17 score of 20 and higher
  • at least one failed/refused/intolerant to antidepressant trial in the current episode as determined by Antidepressant Treatment History Form (ATHF)
  • No safety concerns endorsed on TMS Screening and Information Form

You may not qualify if:

  • lifetime MINI diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, delusional disorder, current psychotic symptoms, post traumatic stress disorder, obsessive compulsive disorder, autism spectrum disorder, a history of epilepsy or any other major neurological disorder
  • history of substance use disorders (moderate to severe) within the last 3 months as determined by MINI
  • concomitant major unstable medical illness
  • acutely suicidal or high risk for suicide as assessed by a study psychiatrist
  • not eligible to receive TMS or MRI as indicated by TMS Screening and Information Form
  • a change in treatment status during the study trial that will be considered a confound to the study. This includes change in medication or Cognitive Behavioral Therapy, each reviewed case by case by the study psychiatrists.
  • medications that are considered a confound to the study including benzodiazepines, antipsychotics, mood stabilizers, stimulants and anticonvulsants.
  • missing more than 20% of the treatment sessions consecutively (i.e., 2 sessions in a row) or 40% (i.e., 4 sessions) within two weeks
  • have failed brain stimulation in the past

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

Related Publications (2)

  • Dhami P, Moreno S, Croarkin PE, Blumberger DM, Daskalakis ZJ, Farzan F. Baseline markers of cortical excitation and inhibition predict response to theta burst stimulation treatment for youth depression. Sci Rep. 2023 Nov 4;13(1):19115. doi: 10.1038/s41598-023-45107-1.

    PMID: 37925557DERIVED

  • Dhami P, Atluri S, Lee J, Knyahnytska Y, Croarkin PE, Blumberger DM, Daskalakis ZJ, Farzan F. Neurophysiological markers of response to theta burst stimulation in youth depression. Depress Anxiety. 2021 Feb;38(2):172-184. doi: 10.1002/da.23100. Epub 2020 Oct 1.

    PMID: 33001549DERIVED

Related Links

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Faranak Farzan

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Independent Scientist

Study Record Dates

First Submitted

June 10, 2015

First Posted

June 15, 2015

Study Start

June 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

October 24, 2017

Record last verified: 2017-10

Locations

CA(1)