Synchronized Transcranial Magnetic Stimulation (sTMS) in Major Depressive Disorder

Completed · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

This study is designed to evaluate the safety and efficacy of synchronized transcranial magnetic stimulation (sTMS) using the NeoSync EEG Synchronized TMS device (NEST) in subjects with Major Depressive Disorder. This is a multicenter study in which subjects will be randomized to receive treatment 5 days per week for 6 weeks. Subjects who complete 6 weeks of double-blind treatment may be eligible to receive up to four weeks of open label sTMS therapy or antidepressant medications during the follow-up phase of the study. Follow-up evaluation visits will be conducted during those four weeks, with the frequency of the visits determined by the treatment choice during that timeframe.

Key facts

Study ID

NCT01370733

Run by

Wave Neuroscience

People needed

202

Starts

2012-05-01

Expected to finish

2013-09-01

Last updated by the study team

2015-10-26

Who can join

Age: 22 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects will meet the DSM-IV-TR primary diagnosis of initial or recurrent Major Depressive Disorder by DSM-IV-TR criteria rendered by structured interview using the Mini International Neuropsychiatric Interview (MINI).
• HAM-D17 score >= 17 and Item 1 score greater than or equal to 2.
• Duration of current episode >=8 weeks. The definition of an episode is demarcated by a period of >=2 months when the subject did not meet full criteria for the DSM-IV-TR definition of Major Depressive Episode. Maximum duration of current episode cannot exceed 2 years.
• The baseline EEG is of sufficient duration and quality that it can be processed for quantitative analysis.
• Subjects are willing and able to adhere to the intensive treatment schedule and all required study visits.

You may not qualify if…

• Subjects are unable or unwilling to give informed consent.
• Diagnosed with the following conditions (current unless otherwise stated):
• Any other current primary Axis I mood, anxiety, or psychotic disorder, including bipolar disorder.
• Depression secondary to a general medical condition, or substance-induced.
• History of substance abuse or dependence within the past 6 months (except nicotine and caffeine).
• Any bipolar disorder or psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features in this or previous episodes.
• Eating disorder (current or within the past year).
• Obsessive compulsive disorder (lifetime).
• Post-traumatic stress disorder (current or within the past year).
• ADHD (currently being treated).
• Subjects meeting criteria for Axis II cluster A or B diagnosis based upon DSM-IV TR criteria, which in the judgment of the Investigator may hinder the subjects in completing the procedures required by the study protocol.
• Subjects with a clinically defined neurological disorder 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 (childhood febrile seizures are acceptable and these subjects may be included in the study).
• History of stroke.
• Transient ischemic attack within two years.
• Cerebral aneurysm.
• Dementia.
• Mini Mental Status Exam (MMSE-2) score of =<24.
• Parkinson's disease.
• Huntington's disease.
• Multiple sclerosis.
• Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold. Medications that lower the seizure threshold are included in the Prohibited Concomitant Medication (Section 5.7).
• Subjects who are currently hospitalized due to severity of depression symptoms.

Where it is running

• UCLA Depression Research & Clinic Program — Los Angeles, California, United States
• UCSD Medical Center — San Diego, California, United States
• UCLA-Harbor — Torrance, California, United States
• Hartford Hospital Institute of Living — Hartford, Connecticut, United States
• TMS Specialists Chicago — Chicago, Illinois, United States
• Sheppard Pratt Health System — Baltimore, Maryland, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Center for Mood Disorders and Neuromodulation Therapies, UMDNJ-SOM — Cherry Hill, New Jersey, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Duke University Brain Stimulation and Neurophysiology Center — Durham, North Carolina, United States
• Wake Forest University Medical Center — Winston-Salem, North Carolina, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Mood Disorders Treatment Research Program University of Pittsburgh-Western Psychiatric Institute and Clinic — Pittsburgh, Pennsylvania, United States
• Butler Hospital Mood Disorders Research Program, Brown Department of Psychiatry and Human Behavior — Providence, Rhode Island, United States
• MUSC Institute of Psychiatry, Brain Stimulation Lab — Charleston, South Carolina, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• R/D Clinical Research — Lake Jackson, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.