Major Depressive Disorder, Recurrent, UnspecifiedNCT01361815
Prospective Multicenter Trial to Explore the Tolerability and Safety of the H-Coil Deep TMS in Combination With Serotonin Selective Reuptake Inhibitor(SSRI)
A study testing H-Coil Deep TMS in combination with SSRIs in people with Major Depressive Disorder, Recurrent, Unspecified and Major Depressive Disorder, Single Episode, Unspecified, run by Brainsway at 19 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 68 years
- Conditions the study is for
- Major Depressive Disorder, Recurrent, Unspecified, Major Depressive Disorder, Single Episode, Unspecified
- What is being tested?
- H-Coil Deep TMS in combination with SSRIs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 19 sitesin 4 countries
- Study dates
- Jul 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
19 sites in 4 countries.
19 sites in 4 countries
United States13 sites
Senior Adults Specialty Research
Austin, Texas, 78757
Johns Hopkins University
Baltimore, Maryland, 21205
McLean Hospital - TMS Services
Belmont, Massachusetts, 02478
Medical Uni. Of South Carolina (MUSC)
Charleston, South Carolina, 29425
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390-8898
UC Davis Center for Mind & Brain
Davis, California, 95817
Advanced Mental Health Care Inc. - Juno Beach
Juno Beach, Florida, 33408
University of California (UCLA)
Los Angeles, California, 90095
Greater Nashua Mental Health Center
Nashua, New Hampshire, 03060
Neuropharmacology Services
New York, New York, 10021
Columbia University / New York State Psychiatric Institute
New York, New York, 10032
Advanced Mental Health Care Inc. - Royal Palm Beach
Royal Palm Beach, Florida, 33411
Smart Brain and Health
Santa Monica, California, 90403
Israel3 sites
Beer Yaacov Mental Health Center
Be’er Ya‘aqov
Shalvata Mental Health Center
Hod HaSharon
Hadasah Ein-Karem Medical Center
Jerusalem
Germany2 sites
Universitätsklinikum Bonn, Klinik und Poliklinik für Psychiatrie und Psychotherapie
Bonn
Klinik für Psychiatrie und Psychotherapie, Ludwig-Maximilians-Universität
Munich
About this study
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
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).
- Conditions
- Major Depressive Disorder, Recurrent, Unspecified, Major Depressive Disorder, Single Episode, Unspecified
- Being tested
- H-Coil Deep TMS in combination with SSRIs
- Keywords
- Depression, MDD, SSRIs, TMS
- Medical subject headings
- Depressive Disorder, Major, Recurrence, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H-Coil Deep TMS in combination with SSRIsDevice
Also called H-Coil Deep TMS Treatment
The study group will receive DTMS treatment three times a week for four weeks in combination with SSRI medications.
| Study group | Role | What they receive |
|---|---|---|
| H-Coil Deep TMS Treatment | Other | Not described Receives: Device: H-Coil Deep TMS in combination with SSRIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
The tolerability and safety of H-coil deep rTMS treatment in combination with SSRI medications
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder, Recurrent, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brainsway
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abraham Zangan, Prof., Principal investigator, Weizmann Institute of ScienceYechiel Levkovitz, Prof., Principal investigator, Shalvata Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361815
- Sponsor's protocol ID
- CTP-0002-00
- Status last verified
- Feb 2015
- First submitted
- 26 May 2011
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01361815
- Acronym / sponsor ID
- CTP-0002-00
- Conditions
- Major Depressive Disorder, Recurrent, Unspecified, Major Depressive Disorder, Single Episode, Unspecified
- Keywords
- Depression, MDD, SSRIs, TMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- BrainswayIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H-Coil Deep TMS Treatment | Other | Device: H-Coil Deep TMS in combination with SSRIs |
Who may qualify
- Ages
- 22 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H-Coil Deep TMS in combination with SSRIsAlso: H-Coil Deep TMS TreatmentThe study group will receive DTMS treatment three times a week for four weeks in combination with SSRI medications. | Device | H-Coil Deep TMS Treatment |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abraham Zangan, Prof. principal investigator
Weizmann Institute of Science
Yechiel Levkovitz, Prof. principal investigator
Shalvata Mental Health Center
19 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H-Coil Deep TMS in combination with SSRIs in people with Major Depressive Disorder, Recurrent, Unspecified and Major Depressive Disorder, Single Episode, Unspecified, run by Brainsway at 19 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Israel, Germany, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The tolerability and safety of H-coil deep rTMS treatment in combination with SSRI medications (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.