- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01415154
Maintenance NeuroStar Transcranial Magnetic Stimulation (TMS) in Patients With Major Depressive Disorder
September 30, 2021 updated by: Neuronetics
A 12-Month Prospective Randomized Dual-Arm Pilot Study of Maintenance NeuroStar Transcranial Magnetic Stimulation (TMS) in Patients With Major Depressive Disorder
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.
Study Overview
Status
Completed
Conditions
Intervention / 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.
Study Type
Interventional
Enrollment (Actual)
67
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Rush University Medical Center
-
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Maryland
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Baltimore, Maryland, United States, 21285
- Sheppard Pratt Health System
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Nebraska
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Lincoln, Nebraska, United States, 68526
- Premier Psychiatric Group, L.L.C.
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Rhode Island
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Providence, Rhode Island, United States, 02906
- Butler Hospital
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Washington
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Mercer Island, Washington, United States, 98040
- Center For Anxiety and Depression
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Examining the proportion of patients maintaining a sustained response throughout a 12 month maintenance treatment phase.
Time Frame: 12 month evaluation
|
Sustained response is defined as not requiring TMS reintroduction at every observation point during the maintenance phase.
|
12 month evaluation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare the average time to first reintroduction of TMS between the two maintenance treatment arms.
Time Frame: 12 Month evaluation
|
Change in depressive symptomatology will be assessed across the duration of maintenance treatment using observer and self-administered efficacy measures.
|
12 Month evaluation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: David G. Brock, MD, Neuronetics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
August 10, 2011
First Submitted That Met QC Criteria
August 10, 2011
First Posted (Estimate)
August 11, 2011
Study Record Updates
Last Update Posted (Actual)
October 8, 2021
Last Update Submitted That Met QC Criteria
September 30, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 44-03001-000
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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