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

Completed · Not applicable

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

In brief

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).

Key facts

Study ID

NCT01361815

Run by

Brainsway

People needed

75

Starts

2011-07-01

Expected to finish

2014-12-01

Last updated by the study team

2020-07-15

Who can join

Age: 22 and older, up to 68. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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.

Where it is running

• UC Davis Center for Mind & Brain — Davis, California, United States
• University of California (UCLA) — Los Angeles, California, United States
• Smart Brain and Health — Santa Monica, California, United States
• Advanced Mental Health Care Inc. - Juno Beach — Juno Beach, Florida, United States
• Advanced Mental Health Care Inc. - Royal Palm Beach — Royal Palm Beach, Florida, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• McLean Hospital - TMS Services — Belmont, Massachusetts, United States
• Greater Nashua Mental Health Center — Nashua, New Hampshire, United States
• Neuropharmacology Services — New York, New York, United States
• Columbia University / New York State Psychiatric Institute — New York, New York, United States
• Medical Uni. Of South Carolina (MUSC) — Charleston, South Carolina, United States
• Senior Adults Specialty Research — Austin, Texas, United States
• UT Southwestern Medical Center at Dallas — Dallas, Texas, United States
• Center for Addiction and Mental Health (CAMH) — Toronto, Ontario, Canada
• Universitätsklinikum Bonn, Klinik und Poliklinik für Psychiatrie und Psychotherapie — Bonn, Germany
• Klinik für Psychiatrie und Psychotherapie, Ludwig-Maximilians-Universität — Munich, Germany
• Beer Yaacov Mental Health Center — Be’er Ya‘aqov, Israel
• Shalvata Mental Health Center — Hod HaSharon, Israel
• Hadasah Ein-Karem Medical Center — Jerusalem, Israel

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.