Prospective Multicenter Trial to Explore the Tolerability and Safety of the H-Coil Deep TMS in Combination With Serotonin Selective Reuptake Inhibitor(SSRI)
Status: | Completed |
---|---|
Conditions: | Depression, Major Depression Disorder (MDD) |
Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 22 - 68 |
Updated: | 1/27/2018 |
Start Date: | July 2011 |
End Date: | December 2014 |
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
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).
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).
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.
We found this trial at
14
sites
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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