iTBS for Adolescent Depression: An Open Label Study Evaluating Safety and Efficacy of Treatment
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This is an open label, pilot, feasibility study evaluating effects of Intermittent Theta
      Burst Transcranial Magnetic Stimulation (iTBS) on 5 eligible adolescents for the treatment of
      depression. Safety and tolerability will be evaluated with changes in depression scores, and
      suicidality and non-suicidal self injurious behavior will also be monitored for exploratory
      and safety measures.
    

Detailed description: 
      This study will investigate the efficacy and durability of the effects of Intermittent Theta
      Burst Stimulation (iTBS) in adolescent depression by measuring changes in clinical ratings
      before, during, and after 4 weeks of treatment, up to 12 weeks following treatment. The
      investigators expect that subjects will show: improvement in symptoms over 20 iTBS sessions
      as measured by the Children's Depression Rating Scale Revised (CDRS-R), Hamilton Depression
      Rating Scale (HAM-D) and Non-suicidal Self Injurious Behavior (NSSIB) measures, and
      persistence of this reduction of depressive symptoms through the 12 weeks follow up period of
      the study. In this study, the investigators will investigate the safety of the effects of
      iTBS in adolescent depression. The investigators will investigate safety of the treatment
      regimen by assessing suicidality. The investigators expect suicidal thoughts and behavior
      will reduce with iTBS treatment as measured by the Columbia Suicide Severity Rating Scale
      (C-SSRS) and a psychiatrist's clinical assessment. The investigators also expect that those
      with NSSIB at the start of the trial will have less after iTBS treatments. The investigators
      do not expect any change in cognition measured with the Mini Mental Status Exam (MMSE),
      Trails B, and List Generation. The investigators will investigate treatment feasibility by
      assessing treatment completion and withdrawal. The investigators define the feasibility of
      iTBS will be defined as feasible by as completion of 15/20 (75%) iTBS treatment sessions by
      all subjects and withdrawal from treatment of no more than one of five subjects (20%) due to
      intolerable side effects or persistent symptoms of MDD. Investigation of efficacy,
      durability, safety as well as feasibility simultaneously is essential in this preliminary
      study of the use of iTBS in adolescents in order to justify a larger future study. This study
      will include a screening visit, 20 iTBS treatments, and 3 planned follow up visits.
    

Intervention name(s): iTBS Device/Motor Threshold Coil; iTBS Device/Treatment Coil
Intervention type(s): Device; Device
Intervention description(s): Motor Threshold determination, done prior to starting treatments, determines the location and the intensity for the iTBS treatments. A magnetic field is applied with increasing intensity stimulating the motor region of the brain until there is thumb movement; this indicates the intensity of the treatments; the location for treatment is in the sensory area parallel to this location.; iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes, and sessions are provided 20 times (Monday-Friday for 4 consecutive weeks).
Other intervention name(s): MagProX100 with MagOption Stimulator and Magpro Coil C-B60 or C-B70; MagPro, Models R30 with MagOption, X100 WITH MagOption, Coil Cool-B65
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescent Depression; Teen Depression