Major Depressive Disorder
Conditions
Keywords
child depression, depression, Transcranial Magnetic Stimulation, Adolescent Major Depressive Disorder, TMS, adolescent depression
Brief 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).
Detailed description
To evaluate the antidepressant effects of daily, active TMS (when compared with sham treatment) in adolescents meeting criteria for Major Depressive Disorder, single or recurrent episode. Secondary: To evaluate the acute and long term safety of TMS treatment in adolescent MDD subjects. To evaluate the durability of benefit of TMS treatment over the course of 6 months in subjects who received clinical benefit from acute treatment course(s) . To evaluate the benefit of daily, active, open-label TMS in Phase I subjects who did not receive protocol-defined clinical benefit; as new acute treatment (sham to active) or as extended treatment course (blinded active to open label active) .
Interventions
DEVICEActive NeuroStar® Transcranial Magnetic Stimulation (TMS)
Compare active NeuroStar® coil with sham NeuroStar® coil.
DEVICESham NeuroStar® Transcranial Magnetic Stimulation (TMS)
Compare active NeuroStar® coil with sham NeuroStar® coil.
Sponsors
Neuronetics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 21 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale-24(HAMD24) Total Score Change From Baseline Value. | 6 weeks | The Hamilton Rating Scale for Depression (HRSD), also called the Hamilton Depression Rating Scale (HDRS), sometimes also abbreviated as HAM-D, is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.HAM-D-24 24-item Hamilton Depression Rating Scale; Lower score is better (76 to 0) |
Countries
United States
Participant flow
Pre-assignment details
Data regarding Phase 2 and phase 3 of the study is not available. Primary analyses for the phase 1 data showed the study didnt meet its primary end point and hence no further analyses was done.
Participants by arm
| Arm | Count |
|---|---|
| TMS Active Arm Blinded Active TMS coil Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
Active NeuroStar® Transcranial Magnetic Stimulation (TMS): Compare active NeuroStar® coil with sham NeuroStar® coil. | 48 |
| TMS Sham Arm Blinded Sham TMS coil Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
Sham NeuroStar® Transcranial Magnetic Stimulation (TMS): Compare active NeuroStar® coil with sham NeuroStar® coil. | 55 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Total | TMS Active Arm | TMS Sham Arm |
|---|---|---|---|
| Age, Categorical <=18 years | 62 Participants | 27 Participants | 35 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 21 Participants | 20 Participants |
| Age, Continuous | 17.4 years STANDARD_DEVIATION 2.25 | 17.6 years STANDARD_DEVIATION 2.28 | 17.2 years STANDARD_DEVIATION 2.22 |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment United States | 103 participants | 48 participants | 55 participants |
| Sex: Female, Male Female | 67 Participants | 30 Participants | 37 Participants |
| Sex: Female, Male Male | 36 Participants | 18 Participants | 18 Participants |
| The Hamilton Rating Scale for Depression (HRSD) | 29.15 units on a scale STANDARD_DEVIATION 6.22 | 28.8 units on a scale STANDARD_DEVIATION 5.75 | 29.5 units on a scale STANDARD_DEVIATION 6.69 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 58 |
| other Total, other adverse events | 31 / 54 | 19 / 58 |
| serious Total, serious adverse events | 3 / 54 | 1 / 58 |
Outcome results
Primary
Hamilton Depression Rating Scale-24(HAMD24) Total Score Change From Baseline Value.
The Hamilton Rating Scale for Depression (HRSD), also called the Hamilton Depression Rating Scale (HDRS), sometimes also abbreviated as HAM-D, is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.HAM-D-24 24-item Hamilton Depression Rating Scale; Lower score is better (76 to 0)
Time frame: 6 weeks
Population: Open Label population not analyzed for primary treatment effect. Continued treatment for maintenance
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Phase I TMS Active | Hamilton Depression Rating Scale-24(HAMD24) Total Score Change From Baseline Value. | -11.1 score on a scale | Standard Error 2.03 |
| Phase I TMS Sham | Hamilton Depression Rating Scale-24(HAMD24) Total Score Change From Baseline Value. | -10.6 score on a scale | Standard Error 2 |