Back to resultsProspective Multicenter Trial to Explore the Tolerability and Safety of the H-Coil Deep TMS in Combination With Serotonin Selective Reuptake Inhibitor(SSRI)
Primary Purpose
Major Depressive Disorder, Recurrent, Unspecified, Major Depressive Disorder, Single Episode, Unspecified
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
H-Coil Deep TMS in combination with SSRIs
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder, Recurrent, Unspecified focused on measuring Depression, MDD, SSRIs, TMS
Eligibility Criteria
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.
Sites / Locations
- UC Davis Center for Mind & Brain
- University of California (UCLA)
- Smart Brain and Health
- Advanced Mental Health Care Inc. - Juno Beach
- Advanced Mental Health Care Inc. - Royal Palm Beach
- Johns Hopkins University
- McLean Hospital - TMS Services
- Greater Nashua Mental Health Center
- Neuropharmacology Services
- Columbia University / New York State Psychiatric Institute
- Medical Uni. Of South Carolina (MUSC)
- Senior Adults Specialty Research
- UT Southwestern Medical Center at Dallas
- Center for Addiction and Mental Health (CAMH)
- Universitätsklinikum Bonn, Klinik und Poliklinik für Psychiatrie und Psychotherapie
- Klinik für Psychiatrie und Psychotherapie, Ludwig-Maximilians-Universität
- Beer Yaacov Mental Health Center
- Shalvata Mental Health Center
- Hadasah Ein-Karem Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
H-Coil Deep TMS Treatment
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01361815
Brief Title
Prospective Multicenter Trial to Explore the Tolerability and Safety of the H-Coil Deep TMS in Combination With Serotonin Selective Reuptake Inhibitor(SSRI)
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brainsway
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Recurrent, Unspecified, Major Depressive Disorder, Single Episode, Unspecified
Keywords
Depression, MDD, SSRIs, TMS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
H-Coil Deep TMS Treatment
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
H-Coil Deep TMS in combination with SSRIs
Other Intervention Name(s)
H-Coil Deep TMS Treatment
Intervention Description
The study group will receive DTMS treatment three times a week for four weeks in combination with SSRI medications.
Primary Outcome Measure Information:
Title
The tolerability and safety of H-coil deep rTMS treatment in combination with SSRI medications
Description
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
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abraham Zangan, Prof.
Organizational Affiliation
Weizmann Institute of Science
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yechiel Levkovitz, Prof.
Organizational Affiliation
Shalvata Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Center for Mind & Brain
City
Davis
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California (UCLA)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Smart Brain and Health
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
Advanced Mental Health Care Inc. - Juno Beach
City
Juno Beach
State/Province
Florida
ZIP/Postal Code
33408
Country
United States
Facility Name
Advanced Mental Health Care Inc. - Royal Palm Beach
City
Royal Palm Beach
State/Province
Florida
ZIP/Postal Code
33411
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
McLean Hospital - TMS Services
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Facility Name
Greater Nashua Mental Health Center
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
Facility Name
Neuropharmacology Services
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia University / New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Medical Uni. Of South Carolina (MUSC)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Senior Adults Specialty Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
UT Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8898
Country
United States
Facility Name
Center for Addiction and Mental Health (CAMH)
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Universitätsklinikum Bonn, Klinik und Poliklinik für Psychiatrie und Psychotherapie
City
Bonn
Country
Germany
Facility Name
Klinik für Psychiatrie und Psychotherapie, Ludwig-Maximilians-Universität
City
Munich
Country
Germany
Facility Name
Beer Yaacov Mental Health Center
City
Be'er Ya'aqov
Country
Israel
Facility Name
Shalvata Mental Health Center
City
Hod Hasharon
Country
Israel
Facility Name
Hadasah Ein-Karem Medical Center
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Prospective Multicenter Trial to Explore the Tolerability and Safety of the H-Coil Deep TMS in Combination With Serotonin Selective Reuptake Inhibitor(SSRI)
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