A Prospective Multicenter Double Blind Randomized Controlled Trial to Explore the Tolerability, Safety and Efficacy of the H-Coil Deep Transcranial Magnetic Stimulation (TMS) in Subjects With Major Depression Disorder (MDD)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Major Depressive Disorder
- Sponsor
- Brainsway
- Enrollment
- 233
- Locations
- 22
- Primary Endpoint
- HDRS-21
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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 Depressive Disorder that have been previously unsuccessfully treated with antidepressant medications.
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 major depressive disorder who have been previously unsuccessfully treated with antidepressant medications. Studies of repetitive transcranial magnetic stimulation (rTMS), typically using a figure-8 coil, have shown that stimulating superficial brain regions can be beneficial in treating major depression. Differing from traditional figure-8 coil, the H-coil is designed to stimulate deep brain regions related to motivation, reward, and pleasure. Preliminary studies have been conducted and seem to indicate that through stimulating certain brain areas with the H-coil, dTMS may have an antidepressant effect. The study population will consist of patients with major depressive disorder who have failed adequate medication treatment or shown significant intolerance to medications. The study duration is 18 weeks, with a 2 week period of weaning the patient off medication, followed by 4 weeks of 5 daily treatments and 12 weeks of biweekly treatments. Mood and mental state will be carefully monitored through standard psychological scales and rating during the drug taper-down and throughout treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
HDRS-21
Time Frame: 5 weeks
Secondary Outcomes
- Response rate(5 weeks)
- Remission rates(5 weeks)
- Quality of Life(5 weeks)