Clareo Health | Prospective Multicenter Trial to Explore the Tolerability and Safety of the H-Coil Deep TMS in Combination With Serotonin Selective Reuptake Inhibitor(SSRI)
Prospective Multicenter Trial to Explore the Tolerability and Safety of the H-Coil Deep TMS in Combination With Serotonin Selective Reuptake Inhibitor(SSRI)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Brainsway
Age
22–68
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
