rTMS and Cognitive Training in Youth Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

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
    

Intervention name(s): Repetitive Transcranial Magnetic Stimulation; Cognitive Training; sham Cognitive Training
Intervention type(s): Device; Other; Other
Intervention description(s): 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; Computer-based inactive sham training
Other intervention name(s): MagPro rTMS Device (Magventure A/S, Farum, Denmark)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rTMS; Depression; Youth; TBS; Brain Stimulation; Electrophysiology; Imaging