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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Major Depressive Disorder, Recurrent, Unspecified, Major Depressive Disorder, Single Episode, Unspecified

Intervention / Treatment
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* Device: H-Coil Deep TMS in combination with SSRIs


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: H-Coil Deep TMS Treatment<br> | Device: H-Coil Deep TMS in combination with SSRIs<br>* The study group will receive DTMS treatment three times a week for four weeks in combination with SSRI medications.<br>* Other names: H-Coil Deep TMS Treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, MDD, SSRIs, TMS