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

Brainsway

Status: Completed

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

Treatments: Device: H-Coil Deep TMS in combination with SSRIs

Study type: Interventional

Funder types: Industry

Identifiers

NCT01361815

CTP-0002-00

Details and patient eligibility

About

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).

Enrollment: 75 patients

Sex: All

Ages: 22 to 68 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

H-Coil Deep TMS Treatment

Other group

Treatment:

Device: H-Coil Deep TMS in combination with SSRIs