DepressionrTMSECTNCT02080507
rTMS in Treatment Resistant Depression
A study testing Active Neuronetics rTMS stimulator and Inactive Neuronetics rTMS stimulator in people with Depression, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of rTMS as an alternative treatment to ECT. The study will also provide data for a power analysis to support a larger clinical trial if there is evidence of a clinically relevant treatment effect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Active Neuronetics rTMS stimulator and Inactive Neuronetics rTMS stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of unipolar major depressive disorder or bipolar disorder, depressed phase and on medication to prevent a manic episode
- Pretreatment Montgomery Åsberg Depression Rating Scale (MADRS) score ≥ 20
- Over age 18 years
- Meeting criteria for ECT according to standards outlined in American Psychiatric Association Task Force on Electroconvulsive Therapy (2001) (American Psychiatric Association Task Force on Electroconvulsive Therapy: The Practice of Electroconvulsive Therapy: Recommendations for Treatment, Training and Privileging, Task Force Report on ECT, 2nd Edition. Washington, DC, American Psychiatric Association, 2001) and qualifying for ECT in the opinion of the study physician and the subject's psychiatric provider.
- Subjects may be on psychotropic medications including antidepressants, antipsychotics, benzodiazepines and anticonvulsants but the dosage of the medication must be stable for at least 6 weeks
- Able and willing to provide informed consent
Who cannot join
- Be pregnant or lactating, planning to become pregnant within the next three months or sexually active and not using birth control.
- 2. Diagnosis with the following conditions (current unless otherwise stated):
- Have a neurological disorder, including a history of seizures, cerebrovascular disease, primary or secondary tumors in central nervous system, stroke, cerebral aneurysm or movement disorder or any lifetime history of loss of consciousness due to head injury.
- Any current Axis 1 psychotic disorder (including substance-induced psychosis, psychotic disorder due to a medical condition, or major depression with psychotic features), as defined by the MINI ( Mini International Neuropsychiatric Interview; English Version 7.0.0 for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); Copyright 1992---2014 Sheehan DV) at the screening visit;
- Any lifetime Axis 1 psychotic disorder (excluding substance-induced psychosis, or psychotic disorder due to a medical condition), or as defined by the MINI at the screening visit;
- Any current Axis II personality disorder that would interfere in the participation of the study as determined through medical history or in the opinion of the investigator;
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- Have a current amnestic disorder, dementia, or delirium as defined by Montreal Cognitive Assessment of less than or equal to 16;
- Any illicit substance use as determined by positive toxicology screen for drugs of abuse; or alcohol and/or substance abuse or dependence within the past 3 months (90 days) as determined by the MINI at the screening visit
- Treatment histories including:
- Failure to clinically remit to an adequate trial of electroconvulsive therapy (ECT), defined as 8 bilateral or 10 unilateral treatments, in the current episode;
- Have failed prior treatment with vagal nerve stimulation (VNS);
- Prior treatment with TMS.
- Have active suicidal intent or plan as defined by a positive answer to questions 4 and/or 5 on the Columbia-Suicide Severity Rating Scale (CSSRS): Screening version; or more than one suicide attempt in lifetime; or a suicide attempt in the past twelve months; or in the Investigator's opinion, is likely to attempt suicide within the next six months.
- Participation in any drug or device clinical trial in the six weeks (42 days) prior to the screening visit and/or participation in another clinical trial for the duration of the study.
- Presence of any other condition or circumstance that, in the opinion of the investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University at Wesley Woods Hospital
Atlanta, Georgia, 30329
About this study
The purpose of this study is to determine the safety and efficacy of rTMS as an alternative treatment to ECT. The study will also provide data for a power analysis to support a larger clinical trial if there is evidence of a clinically relevant treatment effect.
Read the detailed description
rTMS as an alternative to ECT
Background Electroconvulsive therapy (ECT) is highly effective in the treatment of severe depression (UK ECT Review Group, 2003). During the past decade, transcranial magnetic stimulation has emerged as a new anti-depressant treatment (e.g. Berman et al, 2000). Some randomized trials suggest that repetitive transcranial magnetic stimulation (rTMS) might be as effective as ECT in the treatment of non-psychotic depression (Grunhaus et al, 2000, 2003; Janicak et al, 2002; Rosa et all, 2003; Pridmore et al, 2000; Pridmore, 2000 ). Even at 3 and 6 month follow up, patients treated with rTMS continue to do as well as those treated with ECT (Dannon et al, 2002). A recent review also supported the efficacy of rTMS in treatment resistant depression (Lee et al, 2012). However, other reviews and meta-analyses show only moderate enthusiasm for transcranial magnetic stimulation as an alternative to ECT (e.g. Martin et al, 2003; Schlaepfer et al, 2003) and emphasize the need for further studies.
Given the small number of side effects and comparable efficacy to ECT, we would like to continue investigating rTMS as an alternative to ECT. The study will aim to compare the efficacy of sham vs. active rTMS in patients meeting standard criteria for ECT. In addition, the study will also determine the safety and efficacy of this trial and provide data for a power analysis to support a larger clinical trial if there is evidence of a clinically relevant treatment effect.
Our sample population will include 40 adult patients from the Emory University Outpatient Psychiatry Department and Atlanta community. Potential subjects may be identified by their treating physicians as potential subjects for the study and after obtaining permission from the patient, the physician will refer the patient to the research coordinator.
Subjects will enter a 4-week fixed-treatment phase and a variable 2-week extension for clinical improvers (defined below). Subject will receive rTMS treatment according the FDA approved protocol with treatments given five times a week daily Monday through Friday at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
Patients who meet remission criteria (MADRS < 7 for one week, Riedel et al 2010) will be tapered from rTMS. Patients who do not show sufficient improvement at the end of the fixed 4-week period (defined as a < 30% drop from baseline in MADRS scores) will be discontinued. If patients improve sufficiently (i.e., > 30% reduction in MADRS score) but do not meet remission criteria, treatment will continue for up to 2 additional weeks (variable 2-week extension). In the variable phase, the MADRS assessments will be performed twice weekly and improvers, but nonremitters, will continue receiving treatment during the variable 2-week period if they show progressive improvement, defined as at least a 2-point MADRS score reduction at every other rating. The acute trial will be terminated when patients meet the stable remission criteria. The rTMS will then be tapered during a 3-week period.
Data Analysis Dichotomous outcomes (remission, response (defined as a 50% decrease in the baseline MADRS)) will be assessed using a logistic regression model (SAS Institute Inc., Cary, North Carolina) with independent variables of treatment (active vs. sham), medication resistance using the Antidepressant Treatment History Form (ATHF) (low vs. high), current depressive episode duration (log transformed) and age (continuous). The primary analysis will be conducted using the intention-to-treat (ITT) population, defined as all randomized patients who started at least 1 treatment session. All the statistical tests will be performed at the .05 significance level. Interactions were considered significant at the .15 significance level.
A primary purpose of the present study is to determine the safety and efficacy of this trial and provide data for a power analysis to support a larger clinical trial if there is evidence of a clinically relevant treatment effect.
- Conditions
- Depression
- Being tested
- Active Neuronetics rTMS stimulator, Inactive Neuronetics rTMS stimulator
- Keywords
- rTMS, depression, ECT
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Neuronetics rTMS stimulatorDevice
Also called Neuronetics
In the active group, magnetic power output will be delivered to the subject through the coils.
Inactive Neuronetics rTMS stimulatorDevice
Also called Neuronetics
In the inactive group, no magnetic power output will be delivered to the subject through the coils.
| Study group | Role | What they receive |
|---|---|---|
| Active Neuronetics rTMS stimulator | Active comparator | Device: Active Neuronetics Transcranial Magnetic Stimulator. The Neuronetics transcranial magnetic stimulator is an FDA approved device. In the active group, magnetic power output will be delivered to the subject through the coils. Receives: Device: Active Neuronetics rTMS stimulator |
| Inactive Neuronetics rTMS stimulator | Sham comparator | Device: Inactive Neuronetics Transcranial Magnetic Stimulator. The Neuronetics transcranial magnetic stimulator is an FDA approved device. In the inactive group, no magnetic power output will be delivered to the subject through the coils. Receives: Device: Inactive Neuronetics rTMS stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Severity as Assessed by the Montgomery Åsberg Depression Rating Scale (MADRS) Score
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. The MADRS-S instrument has nine questions, with an overall score ranging from 0 to 60 points. A higher score indicates greater depressive symptoms.
Measured: Baseline, Week 6
Secondary outcomes (1)
Quality of Life Assessed by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-Les-SF) Score
The Q-Les-SF assesses the degree of enjoyment and satisfaction experienced by individuals in various areas of daily functioning. The minimum raw score is 14, and the maximum score is 70. Higher scores indicate better satisfaction with life domains (physical health, feelings, work, household duties, school/course work, leisure time activities, and social relations).
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William McDonald MD, Emory University
- Investigators
- William M McDonald, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080507
- Sponsor's protocol ID
- IRB00068138
- Acronym
- rTMSECT
- Status last verified
- Apr 2017
- First submitted
- 4 Mar 2014
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: We had not planned on sharing individual data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- rTMS in Treatment Resistant Depression
- ClinicalTrials.gov ID
- NCT02080507
- Acronym / sponsor ID
- rTMSECT / IRB00068138
- Conditions
- Depression
- Keywords
- rTMS, depression, ECT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Posted 30 May 2017
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 this study is to determine the safety and efficacy of rTMS as an alternative treatment to ECT. The study will also provide data for a power analysis to support a larger clinical trial if there is evidence of a clinically relevant treatment effect.
Detailed description
rTMS as an alternative to ECT
Background Electroconvulsive therapy (ECT) is highly effective in the treatment of severe depression (UK ECT Review Group, 2003). During the past decade, transcranial magnetic stimulation has emerged as a new anti-depressant treatment (e.g. Berman et al, 2000). Some randomized trials suggest that repetitive transcranial magnetic stimulation (rTMS) might be as effective as ECT in the treatment of non-psychotic depression (Grunhaus et al, 2000, 2003; Janicak et al, 2002; Rosa et all, 2003; Pridmore et al, 2000; Pridmore, 2000 ). Even at 3 and 6 month follow up, patients treated with rTMS continue to do as well as those treated with ECT (Dannon et al, 2002). A recent review also supported the efficacy of rTMS in treatment resistant depression (Lee et al, 2012). However, other reviews and meta-analyses show only moderate enthusiasm for transcranial magnetic stimulation as an alternative to ECT (e.g. Martin et al, 2003; Schlaepfer et al, 2003) and emphasize the need for further studies.
Given the small number of side effects and comparable efficacy to ECT, we would like to continue investigating rTMS as an alternative to ECT. The study will aim to compare the efficacy of sham vs. active rTMS in patients meeting standard criteria for ECT. In addition, the study will also determine the safety and efficacy of this trial and provide data for a power analysis to support a larger clinical trial if there is evidence of a clinically relevant treatment effect.
Our sample population will include 40 adult patients from the Emory University Outpatient Psychiatry Department and Atlanta community. Potential subjects may be identified by their treating physicians as potential subjects for the study and after obtaining permission from the patient, the physician will refer the patient to the research coordinator.
Subjects will enter a 4-week fixed-treatment phase and a variable 2-week extension for clinical improvers (defined below). Subject will receive rTMS treatment according the FDA approved protocol with treatments given five times a week daily Monday through Friday at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
Patients who meet remission criteria (MADRS < 7 for one week, Riedel et al 2010) will be tapered from rTMS. Patients who do not show sufficient improvement at the end of the fixed 4-week period (defined as a < 30% drop from baseline in MADRS scores) will be discontinued. If patients improve sufficiently (i.e., > 30% reduction in MADRS score) but do not meet remission criteria, treatment will continue for up to 2 additional weeks (variable 2-week extension). In the variable phase, the MADRS assessments will be performed twice weekly and improvers, but nonremitters, will continue receiving treatment during the variable 2-week period if they show progressive improvement, defined as at least a 2-point MADRS score reduction at every other rating. The acute trial will be terminated when patients meet the stable remission criteria. The rTMS will then be tapered during a 3-week period.
Data Analysis Dichotomous outcomes (remission, response (defined as a 50% decrease in the baseline MADRS)) will be assessed using a logistic regression model (SAS Institute Inc., Cary, North Carolina) with independent variables of treatment (active vs. sham), medication resistance using the Antidepressant Treatment History Form (ATHF) (low vs. high), current depressive episode duration (log transformed) and age (continuous). The primary analysis will be conducted using the intention-to-treat (ITT) population, defined as all randomized patients who started at least 1 treatment session. All the statistical tests will be performed at the .05 significance level. Interactions were considered significant at the .15 significance level.
A primary purpose of the present study is to determine the safety and efficacy of this trial and provide data for a power analysis to support a larger clinical trial if there is evidence of a clinically relevant treatment effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Neuronetics rTMS stimulator | Active comparator | Device: Active Neuronetics rTMS stimulatorDevice: Active Neuronetics Transcranial Magnetic Stimulator. The Neuronetics transcranial magnetic stimulator is an FDA approved device. In the active group, magnetic power output will be delivered to the subject through the coils. |
| Inactive Neuronetics rTMS stimulator | Sham comparator | Device: Inactive Neuronetics rTMS stimulatorDevice: Inactive Neuronetics Transcranial Magnetic Stimulator. The Neuronetics transcranial magnetic stimulator is an FDA approved device. In the inactive group, no magnetic power output will be delivered to the subject through the coils. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of unipolar major depressive disorder or bipolar disorder, depressed phase and on medication to prevent a manic episode
- Pretreatment Montgomery Åsberg Depression Rating Scale (MADRS) score ≥ 20
- Over age 18 years
- Meeting criteria for ECT according to standards outlined in American Psychiatric Association Task Force on Electroconvulsive Therapy (2001) (American Psychiatric Association Task Force on Electroconvulsive Therapy: The Practice of Electroconvulsive Therapy: Recommendations for Treatment, Training and Privileging, Task Force Report on ECT, 2nd Edition. Washington, DC, American Psychiatric Association, 2001) and qualifying for ECT in the opinion of the study physician and the subject's psychiatric provider.
- Subjects may be on psychotropic medications including antidepressants, antipsychotics, benzodiazepines and anticonvulsants but the dosage of the medication must be stable for at least 6 weeks
Key exclusion criteria (15 listed)
- Be pregnant or lactating, planning to become pregnant within the next three months or sexually active and not using birth control.
- 2. Diagnosis with the following conditions (current unless otherwise stated):
- Treatment histories including:
- Have active suicidal intent or plan as defined by a positive answer to questions 4 and/or 5 on the Columbia-Suicide Severity Rating Scale (CSSRS): Screening version; or more than one suicide attempt in lifetime; or a suicide attempt in the past twelve months; or in the Investigator's opinion, is likely to attempt suicide within the next six months.
- Participation in any drug or device clinical trial in the six weeks (42 days) prior to the screening visit and/or participation in another clinical trial for the duration of the study.
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 |
|---|---|---|
| Active Neuronetics rTMS stimulatorAlso: NeuroneticsIn the active group, magnetic power output will be delivered to the subject through the coils. | Device | Active Neuronetics rTMS stimulator |
| Inactive Neuronetics rTMS stimulatorAlso: NeuroneticsIn the inactive group, no magnetic power output will be delivered to the subject through the coils. | Device | Inactive Neuronetics rTMS stimulator |
Primary outcome
Depression Severity as Assessed by the Montgomery Åsberg Depression Rating Scale (MADRS) Score
Time frame: Baseline, Week 6
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. The MADRS-S instrument has nine questions, with an overall score ranging from 0 to 60 points. A higher score indicates greater depressive symptoms.
1 secondary outcome
Quality of Life Assessed by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-Les-SF) Score
Time frame: Baseline, Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. We had not planned on sharing individual data with other researchers
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Survivorship
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.
William M McDonald, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Neuronetics rTMS stimulator and Inactive Neuronetics rTMS stimulator in people with Depression, run by Emory University at 1 site in United States.
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 15 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 30 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Depression Severity as Assessed by the Montgomery Åsberg Depression Rating Scale (MADRS) Score (time frame: Baseline, Week 6). 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 30 May 2017.