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

Major Depressive Disorder, Recurrent, Unspecified Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01361815
• Other study ID #: CTP-0002-00
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Brainsway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 68 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder, Recurrent, Unspecified
• Major Depressive Disorder, Single Episode, Unspecified

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Brainsway

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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