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

Sponsor

Brainsway (Industry)

Overall Status

Completed

CT.gov ID

NCT01361815

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

3.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder, Recurrent, Unspecified Major Depressive Disorder, Single Episode, Unspecified	Device: H-Coil Deep TMS in combination with SSRIs	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

N/A

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

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

The tolerability and safety of H-coil deep rTMS treatment in combination with SSRI medications [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 68 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

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