Clinical trial NCT00927173: Evaluation of the Brainsway Deep Transcranial Magnetic Stimulation (TMS) H-Coil in the Treatment of Major Depression Disorder
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: TMS
Transcranial Magnetic Stimulation
MDD
Major Depressive Disorder
Lead sponsor: Brainsway
Sponsor class: INDUSTRY
First posted: 2009-06-24
Enrollment: 233
Sex: ALL
Minimum age (years): 22
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
  * 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.

Primary outcomes:
measure: HDRS-21
timeFrame: 5 weeks
Secondary outcomes:
measure: Response rate
timeFrame: 5 weeks
measure: Remission rates
timeFrame: 5 weeks
measure: Quality of Life
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California (UCLA)
state: California
city: Sacramento And Davis
country: United States
facility: UC Davis Center for Mind & Brain
state: California
city: Santa Monica
country: United States
facility: Smart Brain and Health
state: California
city: Juno Beach
country: United States
facility: Advanced Mental Health Care Inc. - Juno Beach
state: Florida
city: Royal Palm Beach
country: United States
facility: Advanced Mental Health Care Inc. - Royal Palm Beach
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Belmont
country: United States
facility: McLean Hospital - TMS Services
state: Massachusetts
city: Nashua
country: United States
facility: Greater Nashua Mental Health Center
state: New Hampshire
city: New York
country: United States
facility: Neuropharmacology Services
state: New York
city: New York
country: United States
facility: Columbia University / New York State Psychiatric Institute
state: New York
city: Durham
country: United States
facility: Duke Medical Center Department of Psychiatry & Behavioral Sciences
state: North Carolina
city: Charleston
country: United States
facility: Medical Uni. Of South Carolina (MUSC)
state: South Carolina
city: Austin
country: United States
facility: Senior Adults Specialty Research
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
city: Toronto
country: Canada
facility: Center for Addiction and Mental Health (CAMH)
state: Ontario
city: Neuilly Sur Marne
country: France
facility: EPS Ville-Evrard
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn, Klinik und Poliklinik für Psychiatrie und Psychotherapie
city: Munich
country: Germany
facility: Klinik für Psychiatrie und Psychotherapie, Ludwig-Maximilians-Universität
city: Beer Yaacov
country: Israel
facility: Beer Yaacov Mental Health Center
city: Hod Hasharon
country: Israel
facility: Shalvata Mental Health Center
city: Jerusalem
country: Israel
facility: Hadasah Ein-Karem Medical Center
city: Jerusalem
country: Israel
facility: Kfar Shaul Mental Health Center
Study officials:
affiliation: Shalvat Mental Health Center
name: Yechiel Levkovitz, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Weizmann Institute of Science
name: Abraham Zangen, Dr.
role: PRINCIPAL_INVESTIGATOR
References: