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

Not Applicable

Completed

• Conditions: Major Depressive Disorder, Recurrent, Unspecified; Major Depressive Disorder, Single Episode, Unspecified
• Interventions: Device: H-Coil Deep TMS in combination with SSRIs

• Registration Number: NCT01361815
• Lead Sponsor: Brainsway

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-26
• Study First Submitted QC: 2011-05-26
• Study First Posted: 2011-05-27
• Study Start: 2011-07
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-02
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
H-Coil Deep TMS Treatment	H-Coil Deep TMS in combination with SSRIs	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (19)

Smart Brain and Health; 🇺🇸 Santa Monica, California, United States

UT Southwestern Medical Center at Dallas; 🇺🇸 Dallas, Texas, United States

Center for Addiction and Mental Health (CAMH); 🇨🇦 Toronto, Ontario, Canada

UC Davis Center for Mind & Brain; 🇺🇸 Davis, California, United States

Greater Nashua Mental Health Center; 🇺🇸 Nashua, New Hampshire, United States

Hadasah Ein-Karem Medical Center; 🇮🇱 Jerusalem, Israel

Columbia University / New York State Psychiatric Institute; 🇺🇸 New York, New York, United States

Beer Yaacov Mental Health Center; 🇮🇱 Be'er Ya'aqov, Israel

Neuropharmacology Services; 🇺🇸 New York, New York, United States

Klinik für Psychiatrie und Psychotherapie, Ludwig-Maximilians-Universität; 🇩🇪 Munich, Germany

Medical Uni. Of South Carolina (MUSC); 🇺🇸 Charleston, South Carolina, United States

Shalvata Mental Health Center; 🇮🇱 Hod Hasharon, Israel

University of California (UCLA); 🇺🇸 Los Angeles, California, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Advanced Mental Health Care Inc. - Juno Beach; 🇺🇸 Juno Beach, Florida, United States

McLean Hospital - TMS Services; 🇺🇸 Belmont, Massachusetts, United States

Senior Adults Specialty Research; 🇺🇸 Austin, Texas, United States

Advanced Mental Health Care Inc. - Royal Palm Beach; 🇺🇸 Royal Palm Beach, Florida, United States

Universitätsklinikum Bonn, Klinik und Poliklinik für Psychiatrie und Psychotherapie; 🇩🇪 Bonn, Germany