Clinical trial NCT01361815: Prospective Multicenter Trial to Explore the Tolerability and Safety of the H-Coil Deep TMS in Combination With Serotonin Selective Reuptake Inhibitor(SSRI)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder, Recurrent, Unspecified
Major Depressive Disorder, Single Episode, Unspecified
Keywords: Depression
MDD
SSRIs
TMS
Lead sponsor: Brainsway
Sponsor class: INDUSTRY
First posted: 2011-05-27
Enrollment: 75
Sex: ALL
Minimum age (years): 22
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: The tolerability and safety of H-coil deep rTMS treatment in combination with SSRI medications
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Davis
country: United States
facility: UC Davis Center for Mind & Brain
state: California
city: Los Angeles
country: United States
facility: University of California (UCLA)
state: California
city: Santa Monica
country: United States
facility: Smart Brain and Health
state: California
city: Juno Beach
country: United States
facility: Advanced Mental Health Care Inc. - Juno Beach
state: Florida
city: Royal Palm Beach
country: United States
facility: Advanced Mental Health Care Inc. - Royal Palm Beach
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Belmont
country: United States
facility: McLean Hospital - TMS Services
state: Massachusetts
city: Nashua
country: United States
facility: Greater Nashua Mental Health Center
state: New Hampshire
city: New York
country: United States
facility: Neuropharmacology Services
state: New York
city: New York
country: United States
facility: Columbia University / New York State Psychiatric Institute
state: New York
city: Charleston
country: United States
facility: Medical Uni. Of South Carolina (MUSC)
state: South Carolina
city: Austin
country: United States
facility: Senior Adults Specialty Research
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
city: Toronto
country: Canada
facility: Center for Addiction and Mental Health (CAMH)
state: Ontario
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn, Klinik und Poliklinik für Psychiatrie und Psychotherapie
city: Munich
country: Germany
facility: Klinik für Psychiatrie und Psychotherapie, Ludwig-Maximilians-Universität
city: Be'er Ya'aqov
country: Israel
facility: Beer Yaacov Mental Health Center
city: Hod Hasharon
country: Israel
facility: Shalvata Mental Health Center
city: Jerusalem
country: Israel
facility: Hadasah Ein-Karem Medical Center
Study officials:
affiliation: Weizmann Institute of Science
name: Abraham Zangan, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Shalvata Mental Health Center
name: Yechiel Levkovitz, Prof.
role: PRINCIPAL_INVESTIGATOR
References: