Status:
COMPLETED
Evaluation of the Brainsway Deep Transcranial Magnetic Stimulation (TMS) H-Coil in the Treatment of Major Depression Disorder
Lead Sponsor:
Brainsway
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
22-68 years
Phase:
NA
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of deep brain rTMS, (Transcranial Magnetic Stimulation), a new experimental procedure using the H-Coil, in subjects with Major Depressiv...
Detailed Description
This study is a multicenter, randomized double blind, sham controlled study to evaluate the safety and efficacy of H-coil deep transcranial magnetic stimulation (dTMS) as a treatment for patients with...
Eligibility Criteria
Inclusion
- Outpatients.
- Men and women 22-68 years of age.
- Primary DSM-IV diagnosis of Major Depression, single or recurrent episode.
- Current depressive episode is less than 5 years duration.
- The patient did not respond to at least one but not more than four antidepressant treatments in the current episode.
- Patients who have not completed antidepressant trials due to intolerance to therapy of 2 or more anti-depressant medications in the current episode.
- Satisfactory safety screening questionnaire for transcranial magnetic stimulation.
- Patients not suffering from hypo or hyper-thyroidism based on pre-study TSH level or medically stabilized.
- Patients able to tolerate psychotropic medication washout and no psychotropics during the treatment, other than benzodiazepine at equivalent daily dose of up to 3 mg lorazepam.
Exclusion
- A history of schizophrenia, any psychotic disorder, PTSD, bipolar disorder, OCD, eating disorders (e.g., anorexia nervosa, bulimia) or substance abuse
- A history of panic disorder, social anxiety disorder or personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic) as assessed by the investigator to be primary, causing a higher degree of distress or impairment than MDD.
- A history of any significant medical disease (i.e., cardiovascular, gastrointestinal, etc.)
- A history of seizures, at risk for seizure (e.g., history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes or familial or personal history of epilepsy) or have been diagnosed with a seizure disorder.
- Undergone rTMS treatment, Vagus Nerve Stimulation, or Deep Brain Stimulation.
- Received ECT within the last 3 months or failed to respond to ECT treatment.
- Individuals with a significant neurological disorder or insult including:
- 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
- Parkinson's disease
- Huntington's chorea
- Multiple sclerosis
- Individuals with hearing loss.
- Any intracranial implant such as 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.
- A cardiac pacemaker, implanted medication pump, intracardiac line, or acute, unstable cardiac disease.
- Use of fluoxetine within 6 weeks of the randomization visit.
- Use of a Monoamine Oxidase Inhibitor (MAOI) within 2 weeks of the randomization visit.
- Present suicidal risk as assessed by the investigator.
- Implanted neurostimulators.
- History of abnormal MRI.
- 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.
- Clinically significant laboratory abnormality, in the opinion of the Investigator based on CBC and biochemistry.
- Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.
- Women: if pregnant, planning on becoming pregnant, or currently nursing.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT00927173
Start Date
September 1 2009
End Date
June 1 2012
Last Update
July 15 2020
Active Locations (22)
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1
University of California (UCLA)
Los Angeles, California, United States, 90095
2
UC Davis Center for Mind & Brain
Sacramento and Davis, California, United States, 95817
3
Smart Brain and Health
Santa Monica, California, United States, 90403
4
Advanced Mental Health Care Inc. - Juno Beach
Juno Beach, Florida, United States, 33408