Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depress… (NCT02586688) | Clinical Trial Compass
CompletedNot Applicable
Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents
United States112 participantsStarted 2015-10
Plain-language summary
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).
Who can participate
Age range12 Years – 21 Years
SexALL
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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 schizo…
What they're measuring
1
Hamilton Depression Rating Scale-24(HAMD24) Total Score Change From Baseline Value.