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

July 13, 2020 updated by: Brainsway

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Center for Addiction and Mental Health (CAMH)
  • Germany
      • Bonn, Germany
        • Universitätsklinikum Bonn, Klinik und Poliklinik für Psychiatrie und Psychotherapie
      • Munich, Germany
        • Klinik für Psychiatrie und Psychotherapie, Ludwig-Maximilians-Universität
  • Israel
      • Be'er Ya'aqov, Israel
        • Beer Yaacov Mental Health Center
      • Hod Hasharon, Israel
        • Shalvata Mental health Center
      • Jerusalem, Israel
        • Hadasah Ein-Karem Medical Center
  • United States
    • California
      • Davis, California, United States, 95817
        • UC Davis Center for Mind & Brain
      • Los Angeles, California, United States, 90095
        • University of California (UCLA)
      • Santa Monica, California, United States, 90403
        • Smart Brain and Health
    • Florida
      • Juno Beach, Florida, United States, 33408
        • Advanced Mental Health Care Inc. - Juno Beach
      • Royal Palm Beach, Florida, United States, 33411
        • Advanced Mental Health Care Inc. - Royal Palm Beach
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • McLean Hospital - TMS Services
    • New Hampshire
      • Nashua, New Hampshire, United States, 03060
        • Greater Nashua Mental Health Center
    • New York
      • New York, New York, United States, 10021
        • Neuropharmacology Services
      • New York, New York, United States, 10032
        • Columbia University / New York State Psychiatric Institute
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical Uni. Of South Carolina (MUSC)
    • Texas
      • Austin, Texas, United States, 78757
        • Senior Adults Specialty Research
      • Dallas, Texas, United States, 75390-8898
        • UT Southwestern Medical Center at Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • H-Coil Deep TMS Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The tolerability and safety of H-coil deep rTMS treatment in combination with SSRI medications
Time Frame: 4 weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brainsway

Investigators

  • Principal Investigator: Abraham Zangan, Prof., Weizmann Institute of Science
  • Principal Investigator: Yechiel Levkovitz, Prof., Shalvata Mental health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

May 26, 2011

First Submitted That Met QC Criteria

May 26, 2011

First Posted (Estimate)

May 27, 2011

Study Record Updates

Last Update Posted (Actual)

July 15, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP-0002-00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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