Last updated: January 30, 2024
Sponsor: Mayo Clinic
Overall Status: Completed
Phase
N/A
Condition
Affective Disorders
Depression (Major/severe)
Mood Disorders
Treatment
NeuroStar XPLOR®
NeuroStar TMS Therapy® System
Clinical Study ID
NCT03363919
17-004958
1R01MH113700-01
Ages 12-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Depressed adolescent participants will have a primary diagnoses of MDD based on aclinical and structured interview with the MINI
- Depression symptoms severity of a 40 or greater based on evaluation with theChildren's Depression Rating Scale Revised (CDRS-R) at screening and baseline visits.Further, the total score of the baseline CDRS-R score must not have had a 25% orgreater decrease from the screening CDRS-R score
- The duration of the current episode of depression must be 4 weeks or more but 3 yearsor less.
- For any participant currently receiving antidepressant medication, the referringclinician must determine that insufficient benefit is being received from thistreatment and it is clinically appropriate to discontinue the existing antidepressant.
- Participants in psychotherapy are eligible provided that this was initiated 4 weeksprior to enrollment and that the frequency of visits will be maintained during studyparticipation.
Exclusion
Exclusion criteria:
- The following psychiatric comorbidities are exclusionary: psychotic disorders, bipolardisorders, anorexia nervosa, bulimia nervosa, and substance use disorders within thepast year (with the exception of caffeine and tobacco)
- A positive urine drug screen at baseline
- Seizure history
- Family history of epilepsy in a first degree relative
- Head trauma with loss of consciousness for greater than 5 minutes
- Any true positive findings on the rTMS safety screening form.
- Any concurrent psychotropic medications (for potential participants receivingantidepressants or psychotropic medications, the referring clinician must determinethat insufficient benefit is being received from the treatment and if clinicallyappropriate, discontinue existing antidepressants and other psychotropic medications)
- Prohibited concomitant medications (See Appendix A)
- Pregnancy or suspected pregnancy in female Participants (assessed with urine pregnancytest)
- Conductive, ferromagnetic, or other magnetic-sensitive metals implanted in thesubject's head within 30 cm of the treatment coil excluding the mouth that cannotsafely be removed. Examples include cochlear implants, implantedelectrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry andhair barrettes.
- Prior brain surgery
- Risk for increased intracranial pressure such as a brain tumor
- Any unstable medical condition
- History of treatment with ECT or TMS Therapy for any disorder
- Use of any investigational drug within 4 weeks of the baseline visit
- Initiation of a new psychotherapeutic treatment within the past 4 weeks
- Suicide attempt within the previous 6 months that required medical treatment or ≥ 2attempts in the past 12 months, or has a clear cut plan for suicide and states thathe/she cannot guarantee that he/she will inform a family member or call his/herpsychiatrist or the investigator if the impulse to implement the plan becomessubstantial during the study; or, in the investigator's opinion, is likely to attemptsuicide within the next 6 months.
Study Design
Total Participants: 47
Treatment Group(s): 2
Primary Treatment: NeuroStar XPLOR®
Phase:
Study Start date:
September 24, 2018
Estimated Completion Date:
March 03, 2023
Study Description
Connect with a study center
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.