Major Depressive Disorder
Conditions
Keywords
TMS, Major Depressive Disorder, NeuroStar TMS
Brief summary
The purpose of this study is to evaluate the efficacy of scheduled maintenance Transcranial Magnetic Stimulation (TMS) treatment compared to on-demand TMS treatment for symptomatic worsening in patients who have shown a clinical response to acute TMS treatment.
Detailed description
This is a 12-month maintenance treatment study for patients who have responded to a 6 week course of acute TMS treatment for major depressive disorder (MDD). The study will seek to assess the change in depressive symptomatology across the duration of maintenance treatment using observer and self-administered efficacy measures. Describe the efficacy of TMS re-introduction in patients not receiving maintenance pharmacotherapy who show a recurrence of depressive symptoms. Assess the safety and durability of acute TMS therapy followed by maintenance TMS treatment for up to 12 months.
Interventions
DEVICENeuroStar TMS
NeuroStar TMS treatmant - 120% of Observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/sessions for 6 days. 3 treatments in taper week 1, 2 treatments in taper week 2 and 1 treatment in taper week 3.
Sponsors
Neuronetics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Primary diagnosis by DSM-IV criteria for Major Depressive Episode, single episode or recurrent course of illness, with the additional stipulation of a duration for this episode of ≥ 4 weeks and CGI-S ≥ 4. * Duration of current episode of depression ≤ 3 years (the definition of an episode is demarcated by a period of ≥ 2 months when the patient did not meet full criteria for the DSM-IV definition of Major Depressive Episode. * Capable and willing to provide informed consent. * Signed HIPAA authorization. * Able to adhere with the treatment schedule, and withdrawal of ongoing pharmacotherapy. * If currently taking antidepressant pharmacotherapy, must be clinically appropriate to discontinue treatment with those agents.
Exclusion criteria
* Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption). * Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated): * Depression secondary to a general medical condition, or substance- induced; * Seasonal pattern of depression as defined by DSM-IV; * History of substance abuse or dependence within the past year except nicotine and caffeine); * Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features in this or previous episodes; * Bipolar disorder; * Eating disorder (current or within the past year); * Obsessive compulsive disorder (lifetime); or * Post-traumatic stress disorder (current or within the past year). * An Axis II Personality Disorder, which in the judgment of the Investigator may hinder the patient in completing the procedures required by the study protocol. * Individuals with a clinically defined neurological disorder or insult including, but not limited to: * Any condition likely to be associated with increased intracranial pressure; * Space occupying brain lesion; * History of cerebrovascular accident; * Transient ischemic attack within two years; * Cerebral aneurysm; * Dementia; * Parkinson's disease; * Huntington's chorea; * Multiple sclerosis. * Increased risk of seizure for any reason, including but not limited to prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for ≥ 5 minutes. * History of treatment with Vagus Nerve Stimulation. * Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Maintaining a Sustained Response Throughout a 12 Month Maintenance Treatment Phase. | 12 month evaluation | Sustained response is defined as not requiring TMS reintroduction at every observation point during the maintenance phase. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Time to First Reintroduction of TMS Between the Two Maintenance Treatment Arms. | 12 Month evaluation | Change in depressive symptomatology will be assessed across the duration of maintenance treatment using observer and self-administered efficacy measures. |
Countries
United States
Participant flow
Pre-assignment details
18 patients did not continue to randomization A) 12 failed randomization criteria: Acute phase endpoint HAMD17 total score \<15 and had more than 25% improvement in total score HAMD17 compared with baseline B) 2 Patients moved C) 2 patients had inadequate response during Acute Phase D) 1 patient refused to return E) 1 patient had an unrelated panic attack
Participants by arm
| Arm | Count |
|---|---|
| Scheduled Treatment Arm 3 Week TMS taper, clinical assessments and one NeuroStar TMS session every 4th week of block and TMS reintroduction as needed for clinical deterioration.
NeuroStar TMS: NeuroStar TMS treatmant - 120% of Observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/sessions for 6 days. 3 treatments in taper week 1, 2 treatments in taper week 2 and 1 treatment in taper week 3. | 23 |
| Monthly Observational Follow up Arm 3 Week TMS Taper, clinical assessments and office follow up every 4th week of block and NeuroStar TMS reintroduction as needed for clinical deterioration.
NeuroStar TMS: NeuroStar TMS treatmant - 120% of Observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/sessions for 6 days. 3 treatments in taper week 1, 2 treatments in taper week 2 and 1 treatment in taper week 3. | 26 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lack of Efficacy | 4 | 5 |
| Overall Study | Lost to Follow-up | 1 | 4 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Satisfactory Response | 0 | 1 |
| Overall Study | Withdrawal by Subject | 7 | 8 |
Baseline characteristics
| Characteristic | Scheduled Treatment Arm | Monthly Observational Follow up Arm | Total |
|---|---|---|---|
| Age, Continuous | 48.2 years STANDARD_DEVIATION 13.3 | 49.0 years STANDARD_DEVIATION 9.8 | 48.6 years STANDARD_DEVIATION 10.2 |
| Sex: Female, Male Female | 12 Participants | 18 Participants | 30 Participants |
| Sex: Female, Male Male | 11 Participants | 8 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 23 | 0 / 26 |
| serious Total, serious adverse events | 0 / 23 | 0 / 26 |
Outcome results
Primary
Number of Patients Maintaining a Sustained Response Throughout a 12 Month Maintenance Treatment Phase.
Sustained response is defined as not requiring TMS reintroduction at every observation point during the maintenance phase.
Time frame: 12 month evaluation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Scheduled Treatment Arm | Number of Patients Maintaining a Sustained Response Throughout a 12 Month Maintenance Treatment Phase. | 5 Participants |
| Monthly Observational Follow up Arm | Number of Patients Maintaining a Sustained Response Throughout a 12 Month Maintenance Treatment Phase. | 4 Participants |
Secondary
Average Time to First Reintroduction of TMS Between the Two Maintenance Treatment Arms.
Change in depressive symptomatology will be assessed across the duration of maintenance treatment using observer and self-administered efficacy measures.
Time frame: 12 Month evaluation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Scheduled Treatment Arm | Average Time to First Reintroduction of TMS Between the Two Maintenance Treatment Arms. | 103.5 days | Standard Deviation 61.3 |
| Monthly Observational Follow up Arm | Average Time to First Reintroduction of TMS Between the Two Maintenance Treatment Arms. | 97.8 days | Standard Deviation 59.1 |