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This study will be comprised of two Phases. Phase 1 is a randomized, double-blinded study testing repetitive Transcranial Magnetic Stimulation (rTMS) versus sham (20 treatments over 4 weeks) for adolescents with treatment-resistant depression (TRD). Phase 2, which is optional, consists of two arms of open-labeled active treatment, depending on responder status at the end of Phase 1: (1) bi-weekly maintenance active rTMS (for responders); or (2) a full course of 20 active rTMS treatments over 4 weeks (for non-responders.)
Adolescents and parents will undergo the consent process and initial clinical evaluation. This initial evaluation will be done using the Kiddie Schedule of Affective Disorders and Schizophrenia (K-SADS-PL 2009) and the Children's Depression Rating Scale-Revised (CDRS-R). Participants and their families will also be asked to complete the Antidepressant Treatment Report (ATR), Beck Depression Inventory (BDI-II), Columbia Suicide Severity Rating Scale (C-SSRS), Inventory of Depression and Anxiety Symptoms (IDAS), Temporal Experience of Pleasure Scale (TEPS), Snaith-Hamilton Pleasure Scale (SHAPS), Young Mania Rating Scale (YMRS), Edinburgh Handedness Scale, the Weschler Abbreviated Scale of Intelligence (WASI) and the Tanner Pubertal Staging Questionnaire. Participants will also be asked to complete the NIH Toolbox, Children's Auditory Verbal Learning Test (CAVLT), and the Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test.
Adolescents with TRD who fit inclusion/exclusion criteria (presence of major depression with CDRS-R raw score > 40; a history of at least one failed treatment trial with an antidepressant [as defined by the Antidepressant Treatment Report]; no history of seizure disorder; no presence of MRI contraindications [e.g. claustrophobia or metallic implants]) will be scheduled for:
A. A baseline MRI (described below)
B. 4 weeks of the series of rTMS visits described below
C. A post-treatment MRI
D. A post-treatment clinical assessment (blinded to treatment assignment)
E. 6 monthly follow up visits
Participants will also have the option of participating in an optional Phase 2 treatment before they begin their 6 month follow-up. In Phase 2, participants who responded to active treatment would receive an open-label maintenance dose of rTMS (2 sessions/week) for four weeks. Participants who did not respond to active or sham treatment will receive the open-label active rTMS treatment (5 sessions/week) for four weeks. At the completion of phase 2 treatment, the participants will be asked to repeat the NIH Toolbox, Children's Auditory Verbal Learning Test (CAVLT), and the Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test. Participants who responded to sham treatment will move directly to the follow up sessions. A positive treatment response will be defined as a reduction in CDRS-R score by 50%.
Randomization and rTMS/sham Treatment. Adolescents with TRD will be randomized to either active repetitive rTMS treatment or sham control (15 per group) using the Brainsway rTMS machine in the UMP MINCEP clinic. Participants and clinicians experience active and sham coils as identical; treatments are implemented using a magnetized card, ensuring the double blind.
In the first rTMS visit, the study physician will fit the cap, determine the ideal location for stimulation, and measure MT and MEPa. Adolescents will receive 4 weeks of sham or rTMS, 20 minutes/day, 5 days/week administered by a trained technician. Active treatment will be 43 trains of 20 Hz, stimulation intensity of 120% of the motor threshold, inter-train interval 20 seconds, 1680 pulses/session. A member of research staff will meet weekly with patients to complete the CDRS-R, monitor treatment tolerance using the Side Effects Form for Children and Adolescents, and measure the MT and MEPa. Adolescents will also complete the BDI-II, C-SSRS-SLV, IDAS, TEPS, YMRS, and SHAPS weekly. At week four, the participants will be asked to repeat the NIH Toolbox, Children's Auditory Verbal Learning Test (CAVLT), and the Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test.
Scanning will take place at the Center for Magnetic Resonance Research on a 3T Siemens Prisma scanner at baseline (after the clinical assessment, before the first treatment) and after the last rTMS treatment. Participants will complete MRI safety forms and provide a urine sample to rule out substance use (all participants) and pregnancy (females only). A high-resolution T1 image will be collected (voxel size=1mm isotropic; TR=2530ms; TE=3.65ms, T1=1100ms, flip angle=7°, 5 minutes). Functional data will be acquired using the Human Connectome Project (HCP)38 multiband echo planar imaging sequence (whole brain T2*-weighted functional volumes, 72 contiguous slices; TR=720ms; TE=34.2ms; flip angle=55o, FOV=212mm; voxel size=2mm isotropic; matrix=106x106; multiband factor=8; 12 minutes) during rest with eyes open while viewing a fixation cross.
Participants will be asked to complete a task fMRI in which they are presented with a series of visual stimuli, (human faces of varying emotion expressions with positive, negative or neutral words printed over the faces). During the task, participants will be asked to decide whether the words printed over the faces are positive or negative regardless of the emotion of the face shown. Each subject will complete four distinct blocks of the task.
After the completion of phase 1, all participants will undergo a final assessment during which they will be asked to meet with evaluators again to complete the CDRS-R. They will also be asked to complete the BDI-II, C-SSRS, TEPS, SHAPS, IDAS and NIH Toolbox. At that appointment, the blind will be broken and all participants will be informed of the group they were randomized into and their responder status.
After the completion of all rTMS sessions, participants will be asked to return to see researchers every month for 6 months to assess length of treatment response. Participants who responded to sham in phase 1 will be offered a full course of active open-label rTMS treatment if they relapse during the course of the follow-up sessions.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Treatment Resistant Depression
Active Repetitive Transcranial Magnetic Stimulation (rTMS), Sham Repetitive Transcranial Magnetic Stimulation (rTMS)
Ambulatory Research Center (ARC)
University of Minnesota - Clinical and Translational Science Institute
Published on BioPortfolio: 2015-11-22T22:05:21-0500
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