rTMS and Cognitive Training in Youth Depression
rTMS and Cognitive Training for Treating Youth Depression
1 other identifier
interventional
30
1 country
1
Brief Summary
Youth depression is a highly prevalent disorder with tremendous personal and societal costs. Guideline supported treatments are limited in efficacy and associated with side effects. Novel, safe, and effective treatments are sorely needed. This study will examine the biological targets, and efficacy, of cognitive training in combination with repetitive transcranial magnetic stimulation (rTMS) in non-medicated, depressed youth. If positive, the investigators will have identified an effective, safe, and acceptable alternative treatment for a population with few treatment options. Identifying biological mechanisms of response will ultimately enable clinicians to tailor individual interventions for depressed youth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable depression
Started Aug 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
October 12, 2018
CompletedFirst Posted
Study publicly available on registry
October 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedOctober 25, 2019
October 1, 2019
1.8 years
October 12, 2018
October 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in symptom severity of depression as measured by the Hamilton Rating Scale for Depression - 17
Hamilton Rating Scale for Depression (17-item version) * This scale is used to quantify the severity of symptoms of depression * Scale range: 0-52 (total score) * Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) * Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
5 weeks
Secondary Outcomes (2)
Improvement in self-reported symptom severity of depression as measured by the Beck Depression Inventory-II (BDI-II)
5 weeks
Improvement in symptom severity of depression as measured by the Children's Depression Rating Scale, revised-version (CDRS-R) in youth under 18 years of age
5 weeks
Study Arms (2)
rTMS + Cognitive Training
ACTIVE COMPARATORParticipants will receive repetitive transcranial magnetic stimulation (rTMS) in an open label fashion. In addition, participants will receive active cognitive training (CT) which consists of completing computer-based tasks designed to enhance executive function.
rTMS + Sham Cognitive Training
SHAM COMPARATORParticipants will receive repetitive transcranial magnetic stimulation (rTMS) in an open label fashion. In addition, participants will receive sham cognitive training (CT) which consists of completing computer-based tasks.
Interventions
Intermittent 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 4 weeks.
Computer-based cognitive training designed to enhance executive function
Eligibility Criteria
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
- not taking any oral medication for depression or another psychiatric indication 1-week prior to screening visit
- HRSD-17 score of 20 and higher, to be reviewed on a case by case basis by the study psychiatrists
- at least one failed/refused/intolerant to antidepressant trial in the current episode as determined by 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, obsessive compulsive disorder, autism spectrum disorder, a history of epilepsy or any other major neurological disorder
- diagnosis of borderline personality disorder, assessed on a case by case basis
- at least 6 answers coded "yes" in both substance abuse and dependence sections combined, 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
- medications are considered a confound including selective serotonin reuptake inhibitors, benzodiazepines, antipsychotics, mood stabilizers, stimulants and anticonvulsants, all to be reviewed on a case by case basis
- have failed brain stimulation in the past
- cannot be an expert musician
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H4, Canada
Related Publications (1)
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Z. Jeffrey Daskalakis, MD, PhD
Centre for Addiction and Mental Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Open Label for rTMS, Double-Blinded for Cognitive Training
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair, Temerty Centre for Therapeutic Brain Intervention
Study Record Dates
First Submitted
October 12, 2018
First Posted
October 17, 2018
Study Start
August 1, 2017
Primary Completion
May 31, 2019
Study Completion
May 31, 2019
Last Updated
October 25, 2019
Record last verified: 2019-10