Prospective Multicenter Trial to Explore the Tolerability and Safety of the H-Coil Deep TMS in Combination With Serotonin Selective Reuptake Inhibitor(SSRI)
NCT ID: NCT01361815
Last Updated: 2020-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
75 participants
INTERVENTIONAL
2011-07-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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H-Coil Deep TMS Treatment
H-Coil Deep TMS in combination with SSRIs
The study group will receive DTMS treatment three times a week for four weeks in combination with SSRI medications.
Interventions
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H-Coil Deep TMS in combination with SSRIs
The study group will receive DTMS treatment three times a week for four weeks in combination with SSRI medications.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Men and women 22-68 years of age
* Primary DSM-IV diagnosis of Major Depression, single or recurrent episode confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV).
* Completed the CTP-0001-00 study according to the protocol, i.e., either completed 16 weeks of treatment, or were discontinued from the CTP-0001-00 study protocol after 6 weeks or more from randomization.
* Capable and willing to provide informed consent.
* Able to adhere to the treatment schedule.
Exclusion Criteria
* Current psychotic disorder
* Sensitivity or allergic or other severe adverse event previously reported for Citalopram, Escitalopram, Fluoxetine, Paroxetine, or Sertraline.
* Known or suspected pregnancy
* Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.
* Minimal MT found for both hands is higher than 75% of stimulator power output.
22 Years
68 Years
ALL
No
Sponsors
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Brainsway
INDUSTRY
Responsible Party
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Principal Investigators
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Abraham Zangan, Prof.
Role: PRINCIPAL_INVESTIGATOR
Weizmann Institute of Science
Yechiel Levkovitz, Prof.
Role: PRINCIPAL_INVESTIGATOR
Shalvata Mental Health Center
Locations
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UC Davis Center for Mind & Brain
Davis, California, United States
University of California (UCLA)
Los Angeles, California, United States
Smart Brain and Health
Santa Monica, California, United States
Advanced Mental Health Care Inc. - Juno Beach
Juno Beach, Florida, United States
Advanced Mental Health Care Inc. - Royal Palm Beach
Royal Palm Beach, Florida, United States
Johns Hopkins University
Baltimore, Maryland, United States
McLean Hospital - TMS Services
Belmont, Massachusetts, United States
Greater Nashua Mental Health Center
Nashua, New Hampshire, United States
Neuropharmacology Services
New York, New York, United States
Columbia University / New York State Psychiatric Institute
New York, New York, United States
Medical Uni. Of South Carolina (MUSC)
Charleston, South Carolina, United States
Senior Adults Specialty Research
Austin, Texas, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States
Center for Addiction and Mental Health (CAMH)
Toronto, Ontario, Canada
Universitätsklinikum Bonn, Klinik und Poliklinik für Psychiatrie und Psychotherapie
Bonn, , Germany
Klinik für Psychiatrie und Psychotherapie, Ludwig-Maximilians-Universität
Munich, , Germany
Beer Yaacov Mental Health Center
Be’er Ya‘aqov, , Israel
Shalvata Mental Health Center
Hod HaSharon, , Israel
Hadasah Ein-Karem Medical Center
Jerusalem, , Israel
Countries
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Other Identifiers
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CTP-0002-00
Identifier Type: -
Identifier Source: org_study_id
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