A new procedure for the treatment of depression is currently being studied at 16 clinical sites nationwide.
A large, multi-center clinical trial is currently being conducted to study the effectiveness of Transcranial Magnetic Stimulation (TMS) as a treatment for depression.
Q: What is a clinical trial?
A: A clinical trial is a research study in human volunteers to answer specific health questions.
Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective for patients who have a particular illness. This interventional trial will study a TMS device to evaluate its safety and its ability to improve mood and other symptoms in patients with major depression.
Q: Why do people participate in clinical trials?
A: Volunteers participate in clinical trials because they want to:
- Play a more active role in their own health care
- Gain access to new treatments for their particular illness that are not otherwise available
- Help others by contributing to medical research
Q: What is the purpose of this trial?
A: The trial will test a transcranial magnetic stimulation (TMS) device to evaluate its safety and ability to improve mood and other symptoms in patients with major depression. Information from this trial will be submitted to the U.S. Food and Drug Administration (FDA) to support clearance that would allow U.S. physicians to use TMS Therapy to treat patients with symptoms of depression.
Q: Can anyone participate in a clinical trial?
A: All clinical trials have guidelines, called inclusion/exclusion criteria, that determine who can participate. To join a clinical trial, a patient must qualify for the study according to that study’s criteria. Medical personnel at participating clinical trial sites are responsible for determining if a patient meets the inclusion/exclusion criteria.
Q: What are the inclusion criteria for this trial?
A: To be considered for the trial, patients must have been diagnosed with a major depressive disorder, be able to provide written documentation that they have not received benefit from antidepressant medication use, and be 18 to 70 years old.
Q: What are the exclusion criteria?
A: If any of the following conditions exist, the patient will be excluded from the trial:
- Have received prior treatment with TMS Therapy
- Have a metal object in the head
- Be pregnant or possibly pregnant
- Have been diagnosed with bipolar illness (manic depression) or obsessive-compulsive disorder
- Have been treated with ECT and not responded
- Have increased intracranial pressure for any reason (e.g., head injury or brain tumor)
- Have intracardiac lines of any type (e.g., pacemaker lead or blood pressure monitoring line)
- Have a significant neurologic disorder (e.g., Parkinson's disease)
Q: What will patients have to do?
A: Patients inquiring about the trial will be asked to answer a few questions intended to see if they meet the basic inclusion criteria. Patients who pass this preliminary qualification will be asked if they consent to participate in the study. The study investigator will explain the study and answer any questions the patient may have. Once the patient indicates in writing that he or she consents to the study, the patient will meet with one of the study investigators for a more thorough interview and a brief medical exam.
- Qualified patients will be randomly assigned to one of two possible treatment groups. One group of patients will receive the active TMS treatment; the other will receive an inactive, or "placebo," treatment.
- Patients will receive a 45-minute TMS session, five days per week, over a period of six weeks.
- A trained clinician will perform every treatment.
- Patients will be fully awake and seated in a chair, and all treatments will be conducted on an outpatient basis.
- Patients will be able to go about their normal daily activities after a TMS session.
- All trial-related medical care will be provided at no cost to the patients.
Q: What happens after the study is over?
A: Patients who complete the first study may be eligible to enroll in another TMS study. One follow-up study will enroll eligible patients who did not respond to the initial treatment and offers them unblinded treatment with active TMS for six weeks. A second follow-up study will enroll eligible patients who experienced an improvement in their symptoms in order to follow the progress of their response to treatment and offer retreatment with TMS if symptoms return.
Q: What are the risks?
A: There are risks associated with all investigational trials. Patients who qualify will meet with a physician who will explain the risks, possible side effects, and other details associated with the trial.
More information about clinical trials is available at http://clinicaltrials.gov.
For more information about the clinical trials testing the effectiveness of TMS as a treatment for depression, contact trialinfo@neuronetics.com.
This trial is sponsored by Neuronetics, Inc., a medical device company that is focused on developing therapeutic products for psychiatric and neurological disorders by using the energy in magnetic fields. For more information about Neuronetics: www.neuronetics.com; info@neuronetics.com; 610-640-4202.
