Major Depressive Disorder Clinical Trial
Official title:
A Randomized, Parallel-Group, Sham-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of the Neuronetics Model 2100 CRS Repetitive Transcranial Magnetic Stimulation (rTMS) System in Patients With Major Depression
Verified date | September 2013 |
Source | Neuronetics |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This trial will test the safety and efficacy of a rTMS device for the treatment of major
depressive disorder (MDD). It is hypothesized that rTMS will have an antidepressant effect.
It is a 10-week, randomized, sham-controlled, multicenter trial in outpatients recruited in
both academic and private research centers. It is comprised of three major phases: pre-study
screening, acute treatment, and post-treatment taper. Eligible patients will be randomized
to one of two rTMS treatment groups. One group will receive active rTMS treatment and one
will receive an inactive, or sham, treatment. Each treatment takes about 45 minutes and is
done on an outpatient basis. All trial related medical care is provided at no cost to the
participant.
Status | Completed |
Enrollment | 286 |
Est. completion date | November 2005 |
Est. primary completion date | November 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Primary diagnosis by DSM-IV criteria for Major Depressive Episode, single or recurrent episode as confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV), with the additional stipulation of a duration for this episode of greater than or equal to 4 weeks and CGI-S greater than or equal to 4 - Duration of current episode of depression less than 3 years (the definition of an episode is demarcated by a period of greater than or equal to 2 months when the patient did not meet full criteria for the DSM-IV definition of major depressive episode); - Total HAM-D17 score of greater than or equal to 20 and Item 1 score greater than or equal to 2 at screening visit; - Medication resistance to at least two different antidepressant treatments, defined as resistance to a minimum of 1 and a maximum of 4 antidepressant drug trials of adequate dose and duration in the current episode with adequate dose and duration defined as minimum level 3 on the Antidepressant Treatment History Form (ATHF); or, if patient has not received a sufficient number of antidepressant treatments to assess their medication resistance in the current episode, then the patient must meet level 3 medication resistance by ATHF criteria to at least 1 and no more than 4 drug trials in a previous episode. - Patients who have not completed antidepressant trials of adequate dose and duration due to intolerance to therapy may be included if they have demonstrated intolerance to greater than or equal to 4 anti-depressant medications in the current or a previous episode, and did not meet ATHF criteria for a single adequate treatment trial in the current 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) - 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 - Any history of seizure EXCEPT those therapeutically induced by ECT - History of cerebrovascular accident - Transient ischemic attack within two years - Cerebral aneurysm - Dementia - Mini Mental Status Exam score of less than or equal to 24 - Parkinson's disease - Huntington's chorea - Multiple sclerosis - Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes - A true positive response to any question on the Transcranial Magnetic Stimulation Adult Safety Screen questionnaire - Inability to locate and quantify a motor threshold as defined in the protocol - ECT treatment within 3 months prior to the screening visit - Failure to respond to ECT treatment (i.e., consistent with ATHF level 2 or higher) in this or any previous episode - History of treatment with rTMS therapy for any disorder - History of treatment with Vagus Nerve Stimulation - Use of any investigational drug within 4 weeks of the randomization visit - Use of fluoxetine within 6 weeks of the randomization visit - Use of an MAOI within 2 weeks of the randomization visit - Use of any medication(s) listed on the Excluded Medication List within 1 week of the randomization visit - Significant acute suicide risk, defined as follows: - Suicide attempt within the previous 6 months that required medical treatment; or - Greater than or equal to 2 suicide attempts in the past 12 months; or - Has a clear-cut plan for suicide and states that he/she cannot guarantee that he/she will call his/her regular psychiatrist or the Investigator if the impulse to implement the plan becomes substantial during the study; or - In the Investigator's opinion, is likely to attempt suicide within the next 6 months. - Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease; - Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed - Known or suspected pregnancy - If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the rTMS trial - Positive urine drug screen. (A positive urine drug screen at screening may be repeated once prior to randomization) - Clinically significant laboratory abnormality, in the opinion of the Investigator - Women who are breast-feeding - Women of child-bearing potential not using a medically accepted form of contraception when engaging in sexual intercourse. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Health System | Ann Arbor | Michigan |
United States | UVA Center for Psychiatric Clinical Research | Charlottesville | Virginia |
United States | Northwestern University School of Medicine | Chicago | Illinois |
United States | Rush University Medical Center | Chicago | Illinois |
United States | UT Southwestern Medical Center | Dallas | Texas |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Baylor College of Medicine | Houston | Texas |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | PsyCare | Poway | California |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Washington University School of Medicine | St. Louis | Missouri |
United States | Stanford University School of Medicine | Stanford | California |
United States | Wake Forest University School of Medicine | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Neuronetics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | • Evaluate the antidepressant effect of a specified treatment course of rTMS compared to sham treatment given under the same experimental conditions | 4 to 6 weeks | No | |
Secondary | Safety and tolerability of rTMS | screening through 30 days past last day of participation | Yes | |
Secondary | Change in depressive symptomatology with rTMS | acute phase | No | |
Secondary | Short term durability of rTMS efficacy | during 3 week taper | No |
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