DepressionPhase 2NCT00711568
A Clinical Trial of Magnetic Stimulation in Depression
A Phase 2 study testing Repetitive transcranial magnetic stimulation (rTMS) and Repetitive Transcranial Magnetic Stimulator in people with Depression, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to determine whether repetitive high field transcranial magnetic stimulation of the left or right frontal lobes is beneficial for the treatment of depression that is refractory to antidepressant medication. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Repetitive transcranial magnetic stimulation (rTMS) and Repetitive Transcranial Magnetic Stimulator
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2001to Dec 2007
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients will meet DSM-IV criteria for Major Depressive Episode (without psychotic features).
- All patients will have a total score of 18 or higher and a score of at least 3 on item number 1 of the 24 item Hamilton Rating Scale for Depression (HAM-D).
- All patients will have failed to respond to at least two separate trials of treatment for at least 4 weeks with therapeutic dosages of antidepressant medication (including at least one SSRI) or will have been intolerant of at least three different antidepressant medications (including at least one SSRI).
Who cannot join
- Patient medications will be reviewed prior to enrollment in this study. Patients taking medications that may lower seizure threshold (e.g. metronidazole) will be excluded if the particular medication cannot be stopped or altered without affecting the patient's routine medical care.
- History of neurological illness, epilepsy or seizure disorder, intracranial tumor, or major head trauma leading to loss of consciousness of any length.
- Evidence of central nervous system disease based on baseline complete neurological examination, EEG and contrast-enhanced computerized tomography or magnetic resonance imaging of the brain.
- History of implanted pacemaker or medication pump, metal plate in skull, or metal objects in the eye or skull.
- Axis II diagnosis of Cluster A (paranoid, schizoid, or schizotypal) or Cluster B (antisocial, borderline, histrionic, or narcissistic) personality disorder.
- Axis II diagnosis of mental retardation.
Show all 11Show fewer
- History of schizophrenia, schizoaffective disorder, other functional psychosis, rapid-cycling bipolar illness, or alcohol or drug abuse within the past year.
- Need for rapid clinical response due to conditions such as inanition, psychosis, or suicidality (defined as suicide attempt during the current major depressive episode or having a specific plan for committing suicide).
- A medical condition that is not well controlled, such as diabetes or hypertension, or concomitant medical or nutritional problems necessitating hospitalization.
- Patients taking anticonvulsant mood stabilizers (e.g. carbamazepine, valproic acid).
- Patients otherwise unable to grant informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608
About this study
The purpose of this study is to determine whether repetitive high field transcranial magnetic stimulation of the left or right frontal lobes is beneficial for the treatment of depression that is refractory to antidepressant medication.
Read the detailed description
Despite the utility of modern psychotropic medications, depression remains a medical problem with major societal impact. Electroconvulsive therapy (ECT) is an effective somatic treatment for depression. However, ECT has disadvantages, including risks attendant with general anesthesia and significant cognitive side effects (e.g. confusion and memory loss). An effective but safer somatic therapy for depression could help many patients.
The brain can be stimulated non-invasively by using time-varying magnetic fields to induce electrical currents within the cerebral cortex, a technique known as transcranial magnetic stimulation. Preliminary investigations have provided promising evidence of improved mood associated with high frequency repetitive transcranial magnetic stimulation (rTMS) of left prefrontal cortex in patients with medication-resistant major depression. However, the role of stimulus laterality in the effects of prefrontal rTMS have not been tested systematically. Furthermore, previous studies have likely been confounded by inadequate patient blinding and by a lack of standardization of psychotropic medication treatment. Therefore, we propose to use a carefully controlled clinical trial to directly test the hypothesis that the effects of prefrontal rTMS on mood are related to the laterality of magnetic stimulation. We also intend to improve blinding in comparison to previous studies by: 1) employing a parallel-group study design comparing real and simulated rTMS, as opposed to a crossover study design; 2) using specially constructed sham magnetic coils which can be placed directly on the scalp surface, to more effectively simulate rTMS; and 3) using trains of weak electrical impulses to simulate the cutaneous scalp stimulation associated with rTMS. We will minimize confounding effects of medications and antidepressant withdrawal by: 1) requiring that all patients have fail a monitored clinical trial of an SSRI or other comparable antidepressant prior to rTMS; and 2) continuing pharmacological treatment of depression during the rTMS phase of the trial. Demonstration of therapeutic efficacy of rTMS in this rigorously controlled clinical trial would provide a foundation for further investigation and development of this novel potential treatment modality.
- Conditions
- Depression
- Being tested
- Repetitive transcranial magnetic stimulation (rTMS), Sham rTMS, Repetitive Transcranial Magnetic Stimulator
- Keywords
- depression, magnetic stimulation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulation (rTMS)Procedure or surgery
20 Hz rTMS delivered for 2 seconds (40 stimuli) every 30 seconds for a total of 2000 stimuli (25 minutes)
Sham rTMSProcedure or surgery
20 Hz sham rTMS delivered to L or R frontal region for 2 seconds (40 stimuli) every 30 seconds for a total of 2000 stimuli
Repetitive Transcranial Magnetic StimulatorDevice
Repetitive Transcranial Magnetic Stimulator
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Left dorsolateral frontal 20 Hz TMS delivered for 2 seconds every 30 seconds for a total of 2000 stimuli Receives: Procedure: Repetitive transcranial magnetic stimulation (rTMS); Device: Repetitive Transcranial Magnetic Stimulator |
| Arm 2 | Experimental | Right dorsolateral frontal 20 Hz TMS delivered for 2 seconds every 30 seconds for a total of 2000 stimuli Receives: Procedure: Repetitive transcranial magnetic stimulation (rTMS); Device: Repetitive Transcranial Magnetic Stimulator |
| Arm 3 | Sham comparator | Left or right dorsolateral frontal 20 Hz sham TMS delivered for 2 seconds every 30 seconds for a total of 2000 stimuli Receives: Procedure: Sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale
Measured: Baseline x 2, end of treatment, one week, one month and 3 months post-treatment
Secondary outcomes (1)
Beck Depression Inventory
Measured: Baseline x 2, end of treatment, one week, one month and 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startOct 2001
- Primary completionAug 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- University of Florida
- Responsible party
- Sponsor
- Investigators
- Stephen E. Nadeau, MD BS BS, Principal investigator, North Florida/South Georgia Veterans Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711568
- Sponsor's protocol ID
- MHBS-014-01S
- Other IDs
- Nadeau-573-08
- Status last verified
- Mar 2013
- First submitted
- 3 Jul 2008
- Last updated
- 1 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Triggs WJ, McCoy KJ, Greer R, Rossi F, Bowers D, Kortenkamp S, Nadeau SE, Heilman KM, Goodman WK. Effects of left frontal transcranial magnetic stimulation on depressed mood, cognition, and corticomotor threshold. Biol Psychiatry. 1999 Jun 1;45(11):1440-6. doi: 10.1016/s0006-3223(99)00031-1.
PubMed 10356626Nadeau SE, Bowers D, Jones TL, Wu SS, Triggs WJ, Heilman KM. Cognitive effects of treatment of depression with repetitive transcranial magnetic stimulation. Cogn Behav Neurol. 2014 Jun;27(2):77-87. doi: 10.1097/WNN.0000000000000031.
PubMed 24968008Nadeau SE, Davis SE, Wu SS, Dai Y, Richards LG. A pilot randomized controlled trial of D-cycloserine and distributed practice as adjuvants to constraint-induced movement therapy after stroke. Neurorehabil Neural Repair. 2014 Nov-Dec;28(9):885-95. doi: 10.1177/1545968314532032. Epub 2014 Apr 26.
PubMed 24769437Triggs WJ, Ricciuti N, Ward HE, Cheng J, Bowers D, Goodman WK, Kluger BM, Nadeau SE. Right and left dorsolateral pre-frontal rTMS treatment of refractory depression: a randomized, sham-controlled trial. Psychiatry Res. 2010 Aug 15;178(3):467-74. doi: 10.1016/j.psychres.2010.05.009. Epub 2010 Jun 18.
PubMed 20643486
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Magnetic Stimulation in Depression
- ClinicalTrials.gov ID
- NCT00711568
- Acronym / sponsor ID
- MHBS-014-01S
- Conditions
- Depression
- Keywords
- depression, magnetic stimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- University of Florida
- Study start
- Oct 2001
- Primary completion
- Aug 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 9 Jul 2008 (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 this study is to determine whether repetitive high field transcranial magnetic stimulation of the left or right frontal lobes is beneficial for the treatment of depression that is refractory to antidepressant medication.
Detailed description
Despite the utility of modern psychotropic medications, depression remains a medical problem with major societal impact. Electroconvulsive therapy (ECT) is an effective somatic treatment for depression. However, ECT has disadvantages, including risks attendant with general anesthesia and significant cognitive side effects (e.g. confusion and memory loss). An effective but safer somatic therapy for depression could help many patients.
The brain can be stimulated non-invasively by using time-varying magnetic fields to induce electrical currents within the cerebral cortex, a technique known as transcranial magnetic stimulation. Preliminary investigations have provided promising evidence of improved mood associated with high frequency repetitive transcranial magnetic stimulation (rTMS) of left prefrontal cortex in patients with medication-resistant major depression. However, the role of stimulus laterality in the effects of prefrontal rTMS have not been tested systematically. Furthermore, previous studies have likely been confounded by inadequate patient blinding and by a lack of standardization of psychotropic medication treatment. Therefore, we propose to use a carefully controlled clinical trial to directly test the hypothesis that the effects of prefrontal rTMS on mood are related to the laterality of magnetic stimulation. We also intend to improve blinding in comparison to previous studies by: 1) employing a parallel-group study design comparing real and simulated rTMS, as opposed to a crossover study design; 2) using specially constructed sham magnetic coils which can be placed directly on the scalp surface, to more effectively simulate rTMS; and 3) using trains of weak electrical impulses to simulate the cutaneous scalp stimulation associated with rTMS. We will minimize confounding effects of medications and antidepressant withdrawal by: 1) requiring that all patients have fail a monitored clinical trial of an SSRI or other comparable antidepressant prior to rTMS; and 2) continuing pharmacological treatment of depression during the rTMS phase of the trial. Demonstration of therapeutic efficacy of rTMS in this rigorously controlled clinical trial would provide a foundation for further investigation and development of this novel potential treatment modality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Procedure: Repetitive transcranial magnetic stimulation (rTMS), Device: Repetitive Transcranial Magnetic StimulatorLeft dorsolateral frontal 20 Hz TMS delivered for 2 seconds every 30 seconds for a total of 2000 stimuli |
| Arm 2 | Experimental | Procedure: Repetitive transcranial magnetic stimulation (rTMS), Device: Repetitive Transcranial Magnetic StimulatorRight dorsolateral frontal 20 Hz TMS delivered for 2 seconds every 30 seconds for a total of 2000 stimuli |
| Arm 3 | Sham comparator | Procedure: Sham rTMSLeft or right dorsolateral frontal 20 Hz sham TMS delivered for 2 seconds every 30 seconds for a total of 2000 stimuli |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients will meet DSM-IV criteria for Major Depressive Episode (without psychotic features).
- All patients will have a total score of 18 or higher and a score of at least 3 on item number 1 of the 24 item Hamilton Rating Scale for Depression (HAM-D).
- All patients will have failed to respond to at least two separate trials of treatment for at least 4 weeks with therapeutic dosages of antidepressant medication (including at least one SSRI) or will have been intolerant of at least three different antidepressant medications (including at least one SSRI).
Key exclusion criteria (11 listed)
- Patient medications will be reviewed prior to enrollment in this study. Patients taking medications that may lower seizure threshold (e.g. metronidazole) will be excluded if the particular medication cannot be stopped or altered without affecting the patient's routine medical care.
- History of neurological illness, epilepsy or seizure disorder, intracranial tumor, or major head trauma leading to loss of consciousness of any length.
- Evidence of central nervous system disease based on baseline complete neurological examination, EEG and contrast-enhanced computerized tomography or magnetic resonance imaging of the brain.
- History of implanted pacemaker or medication pump, metal plate in skull, or metal objects in the eye or skull.
- Axis II diagnosis of Cluster A (paranoid, schizoid, or schizotypal) or Cluster B (antisocial, borderline, histrionic, or narcissistic) personality disorder.
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 (rTMS)20 Hz rTMS delivered for 2 seconds (40 stimuli) every 30 seconds for a total of 2000 stimuli (25 minutes) | Procedure or surgery | Arm 1, Arm 2 |
| Sham rTMS20 Hz sham rTMS delivered to L or R frontal region for 2 seconds (40 stimuli) every 30 seconds for a total of 2000 stimuli | Procedure or surgery | Arm 3 |
| Repetitive Transcranial Magnetic StimulatorRepetitive Transcranial Magnetic Stimulator | Device | Arm 1, Arm 2 |
Primary outcome
Hamilton Depression Scale
Time frame: Baseline x 2, end of treatment, one week, one month and 3 months post-treatment
1 secondary outcome
Beck Depression Inventory
Time frame: Baseline x 2, end of treatment, one week, one month and 3 months post-treatment
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 1 Apr 2013.
- Background: PubMed 10356626Triggs WJ, McCoy KJ, Greer R, Rossi F, Bowers D, Kortenkamp S, Nadeau SE, Heilman KM, Goodman WK. Effects of left frontal transcranial magnetic stimulation on depressed mood, cognition, and corticomotor threshold. Biol Psychiatry. 1999 Jun 1;45(11):1440-6. doi: 10.1016/s0006-3223(99)00031-1.
- Derived from this study: PubMed 24968008Nadeau SE, Bowers D, Jones TL, Wu SS, Triggs WJ, Heilman KM. Cognitive effects of treatment of depression with repetitive transcranial magnetic stimulation. Cogn Behav Neurol. 2014 Jun;27(2):77-87. doi: 10.1097/WNN.0000000000000031.
- Derived from this study: PubMed 24769437Nadeau SE, Davis SE, Wu SS, Dai Y, Richards LG. A pilot randomized controlled trial of D-cycloserine and distributed practice as adjuvants to constraint-induced movement therapy after stroke. Neurorehabil Neural Repair. 2014 Nov-Dec;28(9):885-95. doi: 10.1177/1545968314532032. Epub 2014 Apr 26.
- Derived from this study: PubMed 20643486Triggs WJ, Ricciuti N, Ward HE, Cheng J, Bowers D, Goodman WK, Kluger BM, Nadeau SE. Right and left dorsolateral pre-frontal rTMS treatment of refractory depression: a randomized, sham-controlled trial. Psychiatry Res. 2010 Aug 15;178(3):467-74. doi: 10.1016/j.psychres.2010.05.009. Epub 2010 Jun 18.
Related trials for Depression
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Recruiting
Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples
Anxiety, Pregnancy
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.
Stephen E. Nadeau, MD BS BS principal investigator
North Florida/South Georgia Veterans Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Repetitive transcranial magnetic stimulation (rTMS) and Repetitive Transcranial Magnetic Stimulator in people with Depression, run by US Department of Veterans Affairs 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 3 inclusion and 11 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 1 Apr 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Hamilton Depression Scale (time frame: Baseline x 2, end of treatment, one week, one month and 3 months post-treatment). 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 NCT00711568, which also lists 4 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 1 Apr 2013; AzTrials last refreshed its copy on 7 Nov 2026.