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Prospective Multicenter Trial to Explore the Tolerability and Safety of the H-Coil Deep TMS in Combination With Serotonin Selective Reuptake Inhibitor(SSRI)

This study has been completed.
Information provided by (Responsible Party):
Brainsway Identifier:
First received: May 26, 2011
Last updated: February 1, 2015
Last verified: February 2015
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).

Condition Intervention Phase
Major Depressive Disorder, Recurrent, Unspecified Major Depressive Disorder, Single Episode, Unspecified Device: H-Coil Deep TMS in combination with SSRIs Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Brainsway:

Primary Outcome Measures:
  • The tolerability and safety of H-coil deep rTMS treatment in combination with SSRI medications [ Time Frame: 4 weeks ]


    AE incidence, Vital signs, Physical and neurological examination, Young Manic Rating Scale (YMRS), Suicide Ideation Scale (SSI)


    Number of subjects (%) who discontinue the study, Number of subjects (%) who discontinue the study due to AEs

Enrollment: 75
Study Start Date: July 2011
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
H-Coil Deep TMS Treatment Device: 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 Name: H-Coil Deep TMS Treatment


Ages Eligible for Study:   22 Years to 68 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01361815

United States, California
University of California (UCLA)
Los Angeles, California, United States, 90095
UC Davis Center for Mind & Brain
Sacramento and Davis, California, United States, 95817
Smart Brain and Health
Santa Monica, California, United States, 90403
United States, Florida
Advanced Mental Health Care Inc. - Juno Beach
Juno Beach, Florida, United States, 33408
Advanced Mental Health Care Inc. - Royal Palm Beach
Royal Palm Beach, Florida, United States, 33411
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Massachusetts
McLean Hospital - TMS Services
Belmont, Massachusetts, United States, 02478
United States, New Hampshire
Greater Nashua Mental Health Center
Nashua, New Hampshire, United States, 03060
United States, New York
Neuropharmacology Services
New-York, New York, United States, 10021
Columbia University / New York State Psychiatric Institute
New-York, New York, United States, 10032
United States, South Carolina
Medical Uni. Of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
United States, Texas
Senior Adults Specialty Research
Ausitn, Texas, United States, 78757
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-8898
Canada, Ontario
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
Beer Yaacov, Israel
Shalvata Mental Health Center
Hod Hasharon, Israel
Hadasah Ein-Karem Medical Center
Jerusalem, Israel
Sponsors and Collaborators
Principal Investigator: Abraham Zangan, Prof. Weizmann Institute of Science
Principal Investigator: Yechiel Levkovitz, Prof. Shalvata Mental Health Center
  More Information

Responsible Party: Brainsway Identifier: NCT01361815     History of Changes
Other Study ID Numbers: CTP-0002-00
Study First Received: May 26, 2011
Last Updated: February 1, 2015

Keywords provided by Brainsway:

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Disease Attributes
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on September 21, 2017