Major Depressive Disorder Clinical Trial
Official title:
A 12-Month Prospective Randomized Dual-Arm Pilot Study of Maintenance NeuroStar Transcranial Magnetic Stimulation (TMS) in Patients With Major Depressive Disorder
NCT number | NCT01415154 |
Other study ID # | 44-03001-000 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2011 |
Est. completion date | July 2014 |
Verified date | September 2021 |
Source | Neuronetics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 67 |
Est. completion date | July 2014 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Sheppard Pratt Health System | Baltimore | Maryland |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Rush University Medical Center | Chicago | Illinois |
United States | Premier Psychiatric Group, L.L.C. | Lincoln | Nebraska |
United States | Center for Anxiety and Depression | Mercer Island | Washington |
United States | Butler Hospital | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Neuronetics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Examining the proportion 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. | 12 month evaluation | |
Secondary | Compare the 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. | 12 Month evaluation |
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