Prospective Multicenter Trial to Explore the Tolerability and Safety of the H-Coil Deep TMS in Combination With Serotonin Selective Reuptake Inhibitor(SSRI)
A Prospective Multicenter Trial to Explore the Tolerability and Safety of the H-Coil Deep TMS in Combination With Serotonin Selective Reuptake Inhibitor(SSRI) for Subjects With MDD Who Complete/ Discontinued the CTP-0001-00 Protocol
1 other identifier
interventional
75
4 countries
19
Brief Summary
The purpose of the study is to explore the Tolerability and Safety of the H-Coil deep Transcranial Magnetic Stimulation (TMS) in combination with Serotonin Selective Reuptake Inhibitor (SSRI) for Subjects with Major Depression Disorder (MDD) who Complete/ Discontinued the Deep TMS Multicenter study for Subjects with Major Depression Disorder (MDD) (Protocol# CTP-0001-00).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2011
Longer than P75 for not_applicable
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2011
CompletedFirst Posted
Study publicly available on registry
May 27, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJuly 15, 2020
February 1, 2015
3.4 years
May 26, 2011
July 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The tolerability and safety of H-coil deep rTMS treatment in combination with SSRI medications
Safety: AE incidence, Vital signs, Physical and neurological examination, Young Manic Rating Scale (YMRS), Suicide Ideation Scale (SSI) Tolerability: Number of subjects (%) who discontinue the study, Number of subjects (%) who discontinue the study due to AEs
4 weeks
Study Arms (1)
H-Coil Deep TMS Treatment
OTHERInterventions
The study group will receive DTMS treatment three times a week for four weeks in combination with SSRI medications.
Eligibility Criteria
You may qualify if:
- Outpatients
- 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.
You may not qualify if:
- Discontinued from CTP-0001-00 study protocol due to the following reasons: Tolerability and safety reason, Non-compliant with the study protocol, Developed documented suicidal ideation as assessed by the investigator or significant suicide risk based on HDRS-21 item 3 score of 3 or 4 or suicidal attempt
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brainswaylead
Study Sites (19)
UC Davis Center for Mind & Brain
Davis, California, 95817, United States
University of California (UCLA)
Los Angeles, California, 90095, United States
Smart Brain and Health
Santa Monica, California, 90403, United States
Advanced Mental Health Care Inc. - Juno Beach
Juno Beach, Florida, 33408, United States
Advanced Mental Health Care Inc. - Royal Palm Beach
Royal Palm Beach, Florida, 33411, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
McLean Hospital - TMS Services
Belmont, Massachusetts, 02478, United States
Greater Nashua Mental Health Center
Nashua, New Hampshire, 03060, United States
Neuropharmacology Services
New York, New York, 10021, United States
Columbia University / New York State Psychiatric Institute
New York, New York, 10032, United States
Medical Uni. Of South Carolina (MUSC)
Charleston, South Carolina, 29425, United States
Senior Adults Specialty Research
Austin, Texas, 78757, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390-8898, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abraham Zangan, Prof.
Weizmann Institute of Science
- PRINCIPAL INVESTIGATOR
Yechiel Levkovitz, Prof.
Shalvata Mental Health Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2011
First Posted
May 27, 2011
Study Start
July 1, 2011
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
July 15, 2020
Record last verified: 2015-02