NCT03708172

rTMS and Cognitive Training in Youth Depression

rTMS and Cognitive Training for Treating Youth Depression

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Centre for Addiction and Mental Health · Academic / Other
• Sex: All
• Age: 16 Years – 24 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Youth depression affects roughly 10% of the North American population, effecting high costs to both individuals and society at large. Unfortunately, few effective treatments exist. Antidepressant medications such as selective serotonergic reuptake inhibitors (SSRIs) are associated with side effects, and possess marginal efficacy in this age group. Black box warnings persist for antidepressants used in those under 24, owing to concerns that these medications enhance suicidal ideation in this population. While guidelines and randomized controlled trials support the use of cognitive behavior therapy (CBT) as a standalone or combination treatment for depressed youth, a large proportion of youth do not respond to either medication or psychotherapy. The study investigators propose to examine the efficacy of repetitive transcranial magnetic stimulation (rTMS) in conjunction with cognitive training (CT) for depressed youth. rTMS delivered to the dorsolateral prefrontal cortex (DLPFC) is a safe and FDA approved treatment for adults with treatment-resistant depression, and preliminary studies suggest its safety, acceptability, and efficacy in depressed youth. Theta-burst stimulation (TBS) is a new form of rTMS that can achieve antidepressant effects in a quarter of the time of conventional rTMS. TBS is also thought to enhance neural plasticity. In this study, all participants will receive daily (5x a week on weekdays) open-label TBS. In addition, half of the participants will receive computer-based CT designed to enhance executive function, while the other half will receive placebo CT. This approach may capitalize on rTMS-induced neural plasticity, while improving depression associated executive dysfunction. Aim: 1. to investigate the efficacy of combination cognitive training and rTMS applied to the DLPFC in youth depression, and 2. to identify biological targets and predictors of response to combined CT and rTMS intervention in youth depression

Conditions

• Depression

Interventions

Type	Name	Description
DEVICE	Repetitive Transcranial Magnetic Stimulation	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.
OTHER	Cognitive Training	Computer-based cognitive training designed to enhance executive function
OTHER	sham Cognitive Training	Computer-based inactive sham training

Timeline

• Start date: 2017-08-01
• Primary completion: 2019-05-31
• Completion: 2019-05-31
• First posted: 2018-10-17
• Last updated: 2019-10-25

Locations

1 site across 1 country: Canada