Major Depressive DisorderPhase 3NCT00104611
Study of a Repetitive Transcranial Magnetic Stimulation (rTMS) Device for the Treatment of Major Depressive Disorder
A Phase 3 study testing Repetitive Transcranial Magnetic Stimulation in people with Major Depressive Disorder, run by Neuronetics at 13 sites in United States.
Trial summary
This trial will test the safety and efficacy of a rTMS device for the treatment of major depressive disorder (MDD). It is hypothesized that rTMS will have an antidepressant effect. It is a 10-week, randomized, sham-controlled, multicenter trial in outpatients recruited in both academic and private research centers. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 286 participants
- Where
- 13 sitesUnited States
- Study dates
- Jan 2004to Nov 2005
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis by DSM-IV criteria for Major Depressive Episode, single or recurrent episode as confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV), with the additional stipulation of a duration for this episode of greater than or equal to 4 weeks and CGI-S greater than or equal to 4
- Duration of current episode of depression less than 3 years (the definition of an episode is demarcated by a period of greater than or equal to 2 months when the patient did not meet full criteria for the DSM-IV definition of major depressive episode);
- Total HAM-D17 score of greater than or equal to 20 and Item 1 score greater than or equal to 2 at screening visit;
- Medication resistance to at least two different antidepressant treatments, defined as resistance to a minimum of 1 and a maximum of 4 antidepressant drug trials of adequate dose and duration in the current episode with adequate dose and duration defined as minimum level 3 on the Antidepressant Treatment History Form (ATHF); or, if patient has not received a sufficient number of antidepressant treatments to assess their medication resistance in the current episode, then the patient must meet level 3 medication resistance by ATHF criteria to at least 1 and no more than 4 drug trials in a previous episode.
- Patients who have not completed antidepressant trials of adequate dose and duration due to intolerance to therapy may be included if they have demonstrated intolerance to greater than or equal to 4 anti-depressant medications in the current or a previous episode, and did not meet ATHF criteria for a single adequate treatment trial in the current episode.
- Capable and willing to provide informed consent
Show all 9Show fewer
- Signed HIPAA authorization
- Able to adhere with the treatment schedule, and withdrawal of ongoing pharmacotherapy
- If currently taking antidepressant pharmacotherapy, must be clinically appropriate to discontinue treatment with those agents.
Who cannot join
- Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption);
- Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated):
- Depression secondary to a general medical condition, or substance-induced;
- Seasonal pattern of depression as defined by DSM-IV
- History of substance abuse or dependence within the past year (except nicotine and caffeine)
- Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features in this or previous episodes
Show all 47Show fewer
- Bipolar disorder
- Eating disorder (current or within the past year)
- Obsessive compulsive disorder (lifetime)
- Post-traumatic stress disorder (current or within the past year)
- An Axis II Personality Disorder, which in the judgment of the Investigator may hinder the patient in completing the procedures required by the study protocol.
- Individuals with a clinically defined neurological disorder or insult including, but not limited to:
- Any condition likely to be associated with increased intracranial pressure
- Space occupying brain lesion
- Any history of seizure EXCEPT those therapeutically induced by ECT
- History of cerebrovascular accident
- Transient ischemic attack within two years
- Cerebral aneurysm
- Dementia
- Mini Mental Status Exam score of less than or equal to 24
- Parkinson's disease
- Huntington's chorea
- Multiple sclerosis
- Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes
- A true positive response to any question on the Transcranial Magnetic Stimulation Adult Safety Screen questionnaire
- Inability to locate and quantify a motor threshold as defined in the protocol
- ECT treatment within 3 months prior to the screening visit
- Failure to respond to ECT treatment (i.e., consistent with ATHF level 2 or higher) in this or any previous episode
- History of treatment with rTMS therapy for any disorder
- History of treatment with Vagus Nerve Stimulation
- Use of any investigational drug within 4 weeks of the randomization visit
- Use of fluoxetine within 6 weeks of the randomization visit
- Use of an MAOI within 2 weeks of the randomization visit
- Use of any medication(s) listed on the Excluded Medication List within 1 week of the randomization visit
- Significant acute suicide risk, defined as follows:
- Suicide attempt within the previous 6 months that required medical treatment; or
- Greater than or equal to 2 suicide attempts in the past 12 months; or
- Has a clear-cut plan for suicide and states that he/she cannot guarantee that he/she will call his/her regular psychiatrist or the Investigator if the impulse to implement the plan becomes substantial during the study; or
- In the Investigator's opinion, is likely to attempt suicide within the next 6 months.
- Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease;
- Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
- Known or suspected pregnancy
- If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the rTMS trial
- Positive urine drug screen. (A positive urine drug screen at screening may be repeated once prior to randomization)
- Clinically significant laboratory abnormality, in the opinion of the Investigator
- Women who are breast-feeding
- Women of child-bearing potential not using a medically accepted form of contraception when engaging in sexual intercourse.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
UVA Center for Psychiatric Clinical Research
Charlottesville, Virginia, 22903
Northwestern University School of Medicine
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
UT Southwestern Medical Center
Dallas, Texas, 75235
Duke University Medical Center
Durham, North Carolina, 27710
Baylor College of Medicine
Houston, Texas, 77030
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
PsyCare
Poway, California, 92064
Mayo Clinic
Rochester, Minnesota, 55905
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford University School of Medicine
Stanford, California, 94305
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: A Randomized, Parallel-Group, Sham-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of the Neuronetics Model 2100 CRS Repetitive Transcranial Magnetic Stimulation (rTMS) System in Patients With Major Depression
This trial will test the safety and efficacy of a rTMS device for the treatment of major depressive disorder (MDD). It is hypothesized that rTMS will have an antidepressant effect.
It is a 10-week, randomized, sham-controlled, multicenter trial in outpatients recruited in both academic and private research centers. It is comprised of three major phases: pre-study screening, acute treatment, and post-treatment taper. Eligible patients will be randomized to one of two rTMS treatment groups. One group will receive active rTMS treatment and one will receive an inactive, or sham, treatment. Each treatment takes about 45 minutes and is done on an outpatient basis. All trial related medical care is provided at no cost to the participant.
Read the detailed description
This trial will test the safety and efficacy of a rTMS device for the treatment of major depressive disorder.
Major depression is one of the most prevalent and profoundly debilitating diseases worldwide. In a recent report, it is estimated that by the year 2020, depression will be second only to heart disease in magnitude of disease burden as determined by disability-adjusted life years.
Despite major advances in the treatment of depression in the last three decades, further improvements are needed. For instance, with respect to antidepressant pharmacotherapy, only 1/3 of patients are estimated to have a nearly full resolution of their clinical symptoms with their first medication trial. Indeed, partial remission or lack of response to treatment is experienced by the majority of patients. Even with serial trials of antidepressant medication, at least 10 to 15% of patients with major depression are estimated to experience limited benefit and remain chronically depressed with significant psychosocial morbidity. Some patients cannot tolerate the dosage and duration of antidepressant treatments required for treatment trials to be considered adequate. In such patients, intolerance of somatic treatments for major depression leads to chronicity and impaired function, and likely hinders long-term compliance with treatments. For many patients with treatment resistant depression (TRD), more complex regimens of polypharmacotherapy, or the use of electroconvulsive therapy (ECT) are the only currently available treatment options.
Repetitive transcranial magnetic stimulation (rTMS) is a promising alternative to treatments such as ECT or pharmacotherapy for patients presenting with MDD. An rTMS procedure is non-invasive, does not require anesthesia, and may be delivered in an appropriately staffed outpatient setting.
By creating a time-varying magnetic field that is unimpeded by the scalp and skull, TMS can focally and painlessly stimulate the cortex of awake individuals. Through the principle of magnetic induction, the localized pulsed magnetic field generated in the coil at the surface of the head induces an electrical current that depolarizes underlying superficial neurons. It is widely thought that rTMS produces its behavioral effects solely through the induction of current flow in cortex.
Several factors have driven the investigation of rTMS for the treatment of MDD. Early reports of changes in mood in normal participants, the non-invasive nature of rTMS, the favorable side effect profile compared to ECT, and the non-response of a number of MDD patients to pharmacotherapy and/or ECT, all have likely played a role. Since the initial studies, there has continued to be high interest in rTMS as an antidepressant treatment. Multiple trials have been conducted from researchers in diverse environments around the world. However, until now, there have been no rigorously conducted large, multicenter rTMS clinical trials in the treatment of patients with MDD. Because the published research has largely been conducted in single centers, the sample sizes in these antidepressant trials have been small. However, the majority of more than 20 reports have found modest to large antidepressant effects that increase over the trial period. By design, this trial will provide more robust information regarding the antidepressant effect of rTMS in the adult population of MDD patients.
- Conditions
- Major Depressive Disorder
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Keywords
- Major Depressive Disorder, Repetitive Transcranial Magnetic Stimulation, rTMS, Non-invasive Neuromodulation, Antidepressant
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| TMS | Active comparator | Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment 5 days/week for up to 6 weeks Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| Placebo | Placebo comparator | Treatment 5 days/week for up to 6 weeks Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Evaluate the antidepressant effect of a specified treatment course of rTMS compared to sham treatment given under the same experimental conditions
Measured: 4 to 6 weeks
Secondary outcomes (3)
Safety and tolerability of rTMS
Measured: screening through 30 days past last day of participation
Change in depressive symptomatology with rTMS
Measured: acute phase
Short term durability of rTMS efficacy
Measured: during 3 week taper
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2005 (estimated)
- Study startJan 2004
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuronetics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104611
- Sponsor's protocol ID
- 44-01101-000
- Status last verified
- Sep 2013
- First submitted
- 2 Mar 2005
- Last updated
- 20 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Janicak PG, Nahas Z, Lisanby SH, Solvason HB, Sampson SM, McDonald WM, Marangell LB, Rosenquist P, McCall WV, Kimball J, O'Reardon JP, Loo C, Husain MH, Krystal A, Gilmer W, Dowd SM, Demitrack MA, Schatzberg AF. Durability of clinical benefit with transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant major depression: assessment of relapse during a 6-month, multisite, open-label study. Brain Stimul. 2010 Oct;3(4):187-99. doi: 10.1016/j.brs.2010.07.003. Epub 2010 Aug 11.
PubMed 20965447Demitrack MA, Thase ME. Clinical significance of transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant depression: synthesis of recent data. Psychopharmacol Bull. 2009;42(2):5-38.
PubMed 19629020Simpson KN, Welch MJ, Kozel FA, Demitrack MA, Nahas Z. Cost-effectiveness of transcranial magnetic stimulation in the treatment of major depression: a health economics analysis. Adv Ther. 2009 Mar;26(3):346-68. doi: 10.1007/s12325-009-0013-x. Epub 2009 Mar 28.
PubMed 19330495Avery DH, Isenberg KE, Sampson SM, Janicak PG, Lisanby SH, Maixner DF, Loo C, Thase ME, Demitrack MA, George MS. Transcranial magnetic stimulation in the acute treatment of major depressive disorder: clinical response in an open-label extension trial. J Clin Psychiatry. 2008 Mar;69(3):441-51. doi: 10.4088/jcp.v69n0315.
PubMed 18294022Janicak PG, O'Reardon JP, Sampson SM, Husain MM, Lisanby SH, Rado JT, Heart KL, Demitrack MA. Transcranial magnetic stimulation in the treatment of major depressive disorder: a comprehensive summary of safety experience from acute exposure, extended exposure, and during reintroduction treatment. J Clin Psychiatry. 2008 Feb;69(2):222-32. doi: 10.4088/jcp.v69n0208.
PubMed 18232722O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007 Dec 1;62(11):1208-16. doi: 10.1016/j.biopsych.2007.01.018. Epub 2007 Jun 14.
PubMed 17573044
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-Group, Sham-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of the Neuronetics Model 2100 CRS Repetitive Transcranial Magnetic Stimulation (rTMS) System in Patients With Major Depression
- ClinicalTrials.gov ID
- NCT00104611
- Acronym / sponsor ID
- 44-01101-000
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Repetitive Transcranial Magnetic Stimulation, rTMS, Non-invasive Neuromodulation, Antidepressant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- NeuroneticsUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 3 Mar 2005 (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.
This trial will test the safety and efficacy of a rTMS device for the treatment of major depressive disorder (MDD). It is hypothesized that rTMS will have an antidepressant effect.
It is a 10-week, randomized, sham-controlled, multicenter trial in outpatients recruited in both academic and private research centers. It is comprised of three major phases: pre-study screening, acute treatment, and post-treatment taper. Eligible patients will be randomized to one of two rTMS treatment groups. One group will receive active rTMS treatment and one will receive an inactive, or sham, treatment. Each treatment takes about 45 minutes and is done on an outpatient basis. All trial related medical care is provided at no cost to the participant.
Detailed description
This trial will test the safety and efficacy of a rTMS device for the treatment of major depressive disorder.
Major depression is one of the most prevalent and profoundly debilitating diseases worldwide. In a recent report, it is estimated that by the year 2020, depression will be second only to heart disease in magnitude of disease burden as determined by disability-adjusted life years.
Despite major advances in the treatment of depression in the last three decades, further improvements are needed. For instance, with respect to antidepressant pharmacotherapy, only 1/3 of patients are estimated to have a nearly full resolution of their clinical symptoms with their first medication trial. Indeed, partial remission or lack of response to treatment is experienced by the majority of patients. Even with serial trials of antidepressant medication, at least 10 to 15% of patients with major depression are estimated to experience limited benefit and remain chronically depressed with significant psychosocial morbidity. Some patients cannot tolerate the dosage and duration of antidepressant treatments required for treatment trials to be considered adequate. In such patients, intolerance of somatic treatments for major depression leads to chronicity and impaired function, and likely hinders long-term compliance with treatments. For many patients with treatment resistant depression (TRD), more complex regimens of polypharmacotherapy, or the use of electroconvulsive therapy (ECT) are the only currently available treatment options.
Repetitive transcranial magnetic stimulation (rTMS) is a promising alternative to treatments such as ECT or pharmacotherapy for patients presenting with MDD. An rTMS procedure is non-invasive, does not require anesthesia, and may be delivered in an appropriately staffed outpatient setting.
By creating a time-varying magnetic field that is unimpeded by the scalp and skull, TMS can focally and painlessly stimulate the cortex of awake individuals. Through the principle of magnetic induction, the localized pulsed magnetic field generated in the coil at the surface of the head induces an electrical current that depolarizes underlying superficial neurons. It is widely thought that rTMS produces its behavioral effects solely through the induction of current flow in cortex.
Several factors have driven the investigation of rTMS for the treatment of MDD. Early reports of changes in mood in normal participants, the non-invasive nature of rTMS, the favorable side effect profile compared to ECT, and the non-response of a number of MDD patients to pharmacotherapy and/or ECT, all have likely played a role. Since the initial studies, there has continued to be high interest in rTMS as an antidepressant treatment. Multiple trials have been conducted from researchers in diverse environments around the world. However, until now, there have been no rigorously conducted large, multicenter rTMS clinical trials in the treatment of patients with MDD. Because the published research has largely been conducted in single centers, the sample sizes in these antidepressant trials have been small. However, the majority of more than 20 reports have found modest to large antidepressant effects that increase over the trial period. By design, this trial will provide more robust information regarding the antidepressant effect of rTMS in the adult population of MDD patients.
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 |
|---|---|---|
| TMS | Active comparator | Device: Repetitive Transcranial Magnetic StimulationRepetitive Transcranial Magnetic Stimulation (rTMS) Treatment 5 days/week for up to 6 weeks |
| Placebo | Placebo comparator | Device: Repetitive Transcranial Magnetic StimulationTreatment 5 days/week for up to 6 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Primary diagnosis by DSM-IV criteria for Major Depressive Episode, single or recurrent episode as confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV), with the additional stipulation of a duration for this episode of greater than or equal to 4 weeks and CGI-S greater than or equal to 4
- Duration of current episode of depression less than 3 years (the definition of an episode is demarcated by a period of greater than or equal to 2 months when the patient did not meet full criteria for the DSM-IV definition of major depressive episode);
- Total HAM-D17 score of greater than or equal to 20 and Item 1 score greater than or equal to 2 at screening visit;
- Medication resistance to at least two different antidepressant treatments, defined as resistance to a minimum of 1 and a maximum of 4 antidepressant drug trials of adequate dose and duration in the current episode with adequate dose and duration defined as minimum level 3 on the Antidepressant Treatment History Form (ATHF); or, if patient has not received a sufficient number of antidepressant treatments to assess their medication resistance in the current episode, then the patient must meet level 3 medication resistance by ATHF criteria to at least 1 and no more than 4 drug trials in a previous episode.
- Patients who have not completed antidepressant trials of adequate dose and duration due to intolerance to therapy may be included if they have demonstrated intolerance to greater than or equal to 4 anti-depressant medications in the current or a previous episode, and did not meet ATHF criteria for a single adequate treatment trial in the current episode.
Key exclusion criteria (47 listed)
- Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption);
- Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated):
- An Axis II Personality Disorder, which in the judgment of the Investigator may hinder the patient in completing the procedures required by the study protocol.
- Individuals with a clinically defined neurological disorder or insult including, but not limited to:
- Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes
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 |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation | Device | Placebo, TMS |
Primary outcome
• Evaluate the antidepressant effect of a specified treatment course of rTMS compared to sham treatment given under the same experimental conditions
Time frame: 4 to 6 weeks
3 secondary outcomes
Safety and tolerability of rTMS
Time frame: screening through 30 days past last day of participation
Change in depressive symptomatology with rTMS
Time frame: acute phase
Short term durability of rTMS efficacy
Time frame: during 3 week taper
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 20 Sep 2013.
- Derived from this study: PubMed 20965447Janicak PG, Nahas Z, Lisanby SH, Solvason HB, Sampson SM, McDonald WM, Marangell LB, Rosenquist P, McCall WV, Kimball J, O'Reardon JP, Loo C, Husain MH, Krystal A, Gilmer W, Dowd SM, Demitrack MA, Schatzberg AF. Durability of clinical benefit with transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant major depression: assessment of relapse during a 6-month, multisite, open-label study. Brain Stimul. 2010 Oct;3(4):187-99. doi: 10.1016/j.brs.2010.07.003. Epub 2010 Aug 11.
- Derived from this study: PubMed 19629020Demitrack MA, Thase ME. Clinical significance of transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant depression: synthesis of recent data. Psychopharmacol Bull. 2009;42(2):5-38.
- Derived from this study: PubMed 19330495Simpson KN, Welch MJ, Kozel FA, Demitrack MA, Nahas Z. Cost-effectiveness of transcranial magnetic stimulation in the treatment of major depression: a health economics analysis. Adv Ther. 2009 Mar;26(3):346-68. doi: 10.1007/s12325-009-0013-x. Epub 2009 Mar 28.
- Derived from this study: PubMed 18294022Avery DH, Isenberg KE, Sampson SM, Janicak PG, Lisanby SH, Maixner DF, Loo C, Thase ME, Demitrack MA, George MS. Transcranial magnetic stimulation in the acute treatment of major depressive disorder: clinical response in an open-label extension trial. J Clin Psychiatry. 2008 Mar;69(3):441-51. doi: 10.4088/jcp.v69n0315.
- Derived from this study: PubMed 18232722Janicak PG, O'Reardon JP, Sampson SM, Husain MM, Lisanby SH, Rado JT, Heart KL, Demitrack MA. Transcranial magnetic stimulation in the treatment of major depressive disorder: a comprehensive summary of safety experience from acute exposure, extended exposure, and during reintroduction treatment. J Clin Psychiatry. 2008 Feb;69(2):222-32. doi: 10.4088/jcp.v69n0208.
- Derived from this study: PubMed 17573044O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007 Dec 1;62(11):1208-16. doi: 10.1016/j.biopsych.2007.01.018. Epub 2007 Jun 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Repetitive Transcranial Magnetic Stimulation in people with Major Depressive Disorder, run by Neuronetics at 13 sites 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 9 inclusion and 47 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 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
• Evaluate the antidepressant effect of a specified treatment course of rTMS compared to sham treatment given under the same experimental conditions (time frame: 4 to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00104611, which also lists 6 linked publications.
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 20 Sep 2013.