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

Use our guide to learn which trials are right for you!

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).


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
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Austin, Texas 78757
?
mi
from
Austin, TX
Click here to add this to my saved trials
Belmont, Massachusetts 02478
?
mi
from
Belmont, MA
Click here to add this to my saved trials
Charleston, South Carolina 29425
?
mi
from
Charleston, SC
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
267 Cousteau Place
Davis, California 95817
?
mi
from
Davis, CA
Click here to add this to my saved trials
?
mi
from
Juno Beach, FL
Click here to add this to my saved trials
Los Angeles, California 90095
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Nashua, New Hampshire 03060
?
mi
from
Nashua, NH
Click here to add this to my saved trials
901 5th Avenue
New York, New York 10021
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
Royal Palm Beach, Florida 33411
?
mi
from
Royal Palm Beach, FL
Click here to add this to my saved trials
Santa Monica, California 90403
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
?
mi
from
Toronto,
Click here to add this to my saved trials