Maintenance NeuroStar Transcranial Magnetic Stimulation (TMS) in Patients With Major Depressive Disorder

Sponsor

Neuronetics (Other)

Overall Status

Completed

CT.gov ID

NCT01415154

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

11.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Device: NeuroStar TMS	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

67 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A 12-Month Prospective Randomized Dual-Arm Pilot Study of Maintenance NeuroStar Transcranial Magnetic Stimulation (TMS) in Patients With Major Depressive Disorder

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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.
Experimental: 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.	Device: 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.

Arm

Intervention/Treatment

Experimental: 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.

Device: 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.

Experimental: 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.

Device: NeuroStar TMS

Outcome Measures

Primary Outcome Measures

Examining the proportion 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 Outcome Measures

Compare the 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rush University Medical Center	Chicago	Illinois	United States	60612
2	Sheppard Pratt Health System	Baltimore	Maryland	United States	21285
3	Premier Psychiatric Group, L.L.C.	Lincoln	Nebraska	United States	68526
4	Butler Hospital	Providence	Rhode Island	United States	02906
5	Medical University of South Carolina	Charleston	South Carolina	United States	29425
6	Center for Anxiety and Depression	Mercer Island	Washington	United States	98040