Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-005219
NCT ID: NCT02586688
Sponsor Protocol Number: 44-02219-000
About this study
To evaluate the safety and efficacy of daily, active Neurostar® TMS (when compared with sham treatment) in adolescents meeting criteria for Major Depressive Disorder (MDD).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Primary diagnosis of unipolar major depressive disorder, in a current major depressive episode, without psychotic features
- Duration of current episode of depression ≥4 weeks and ≤3 years
- Clinical Global Impression - Severity of Illness ≥ 4
- Resistance to antidepressant treatment in a discrete illness episode
- HAMD24 Item 1 ≥ 2 and total score ≥ 20
- Subjects able to commit to protocol visit schedule
- At the end of the baseline visit, subject must have a HAMD24 score of ≥ 18 and change in score may not be ≥ 25% decrease from that seen at the screening visit
Exclusion Criteria:
- Prior TMS, vagus nerve stimulation (VNS), or electroconvulsive therapy (ECT)
- Contraindication to TMS
- Cardiac pacemakers, implanted medication pumps, intracardiac lines
- History of neurological disorder
- Unstable medical conditions
- Any psychiatric disorder, which in the judgement of the Investigator may hinder the subject in completing the procedures required by the study protocol.
- Significant acute suicide risk
- Inability to locate and quantify a motor threshold
- If sexually active female, not on an accepted method of birth control.
- Diagnoses of the following conditions (current unless otherwise stated):
- Depression secondary to a general medical condition, or substance induced:
- Seasonal pattern of depression as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
- Any psychotic disorder (lifetime), including history of schizophrenia, schizoaffective disorder, other psychosis, psychotic features in this or previous episodes, amnestic disorder,
- Intellectually disabled,
- Substance dependence or abuse within the past year (except nicotine or caffeine),
- Bipolar disorder,
- Obsessive compulsive disorder (lifetime),
- Post-traumatic stress disorder (lifetime),
- Eating disorder (lifetime).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Paul Croarkin, D.O., M.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available