Status:
COMPLETED
Study of a Repetitive Transcranial Magnetic Stimulation (rTMS) Device for the Treatment of Major Depressive Disorder
Lead Sponsor:
Neuronetics
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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, r...
Detailed Description
This trial will test the safety and efficacy of a rTMS device for the treatment of major depressive disorder. Major depression is one of the most prevalent and profoundly debilitating diseases worldw...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT00104611
Start Date
January 1 2004
End Date
November 1 2005
Last Update
September 20 2013
Active Locations (13)
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1
PsyCare
Poway, California, United States, 92064
2
Stanford University School of Medicine
Stanford, California, United States, 94305
3
Northwestern University School of Medicine
Chicago, Illinois, United States, 60611
4
Rush University Medical Center
Chicago, Illinois, United States, 60612