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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Depressive Disorder, Recurrent, Unspecified Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Disease Attributes Major Depressive Disorder, Single Episode, Unspecified Mental Disorders Mood Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

22 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Addiction and Mental Health (CAMH), Toronto, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

H-Coil Deep TMS in combination with SSRIs

Device

The study group will receive DTMS treatment three times a week for four weeks in combination with SSRI medications.

Other names: H-Coil Deep TMS Treatment

Primary outcomes

The tolerability and safety of H-coil deep rTMS treatment in combination with SSRI medications

Time frame: 4 weeks

Safety:

AE incidence, Vital signs, Physical and neurological examination, Young Manic Rating Scale (YMRS), Suicide Ideation Scale (SSI)

Tolerability:

Number of subjects (%) who discontinue the study, Number of subjects (%) who discontinue the study due to AEs

Sponsors and collaborators

Lead sponsor

Brainsway

Industry

Registry information

Official study 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

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: May 27, 2011
Registry last updated: Jul 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed