Bipolar DepressionPhase 1LFMS6txNCT01557192
Low Field Magnetic Stimulation (LFMS) in Mood Disorders: 6 Treatments
A Phase 1 study testing Low Field Magnetic Stimulation Device in people with Bipolar Depression and Unipolar Depression, run by Mclean Hospital at 1 site in United States.
Trial summary
To demonstrate the efficacy of multiple applications of Low Field Magnetic Stimulation (LFMS) as an antidepressant treatment in subjects with mood disorders. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Bipolar Depression, Unipolar Depression
- What is being tested?
- Low Field Magnetic Stimulation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to May 2020
- Phase
- Phase 1
- 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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects MUST be significantly depressed, currently.
- Subjects must not have serious physical illnesses, neurological diseases or dementias.
- Subjects will meet DSM-IV criteria for Bipolar Disorder Type I or II, Major Depressive Disorder, Post Traumatic Stress Disorder, or Obsessive Compulsive Disorder, and be currently depressed.
- Subject must have a Ham-D score > 17, YMRS score < 7 (bipolar subjects only), and a MADRS score > 18.
- Subjects must be capable of providing informed consent.
- Subjects must have an established residence and phone.
- Subjects may be medicated or unmedicated.
Who cannot join
- Dangerous or active suicidal ideation.
- Pregnant or planning on becoming pregnant.
- Substance abuse (cannot meet DSM criteria for substance abuse, no significant drug abuse within last 3 months, no major polysubstance abuse history, no history of dependence in last year, no drug use within last month).
- Mixed mood state or rapid cycling.
- Presence of a pacemaker, neurostimulator, or metal in head or neck.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Field Magnetic Stimulation in Mood Disorders in Six Visits
To demonstrate the efficacy of multiple applications of Low Field Magnetic Stimulation (LFMS) as an antidepressant treatment in subjects with mood disorders.
Read the detailed description
The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. The field and timing parameters of the LFMS pulses, such as pulse timing, duration, frequency, and electric and magnetic field distribution and direction are different from other neurostimulation methods.
The mechanism of action for the antidepressant effects of LFMS is hypothesized to be an effect on dendritic or synaptic activity in the cortex, brought about by low level electrical stimulation applied with particular timing. This is analogous to the synaptic effects of pharmaceutical antidepressants in providing a "boost" to synapses in certain brain regions.
Previous investigations of LFMS included depressed subjects with bipolar disorder. This study will evaluate the antidepressant effects of multiple LFMS treatments in bipolar disorder and major depressive disorder.
- Conditions
- Bipolar Depression, Unipolar Depression
- Being tested
- Low Field Magnetic Stimulation Device
- Keywords
- Depression, Bipolar Depression, LFMS, Electromagnetic Stimulation
- Medical subject headings
- Bipolar Disorder, Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Field Magnetic Stimulation DeviceDevice
Also called LFMS
The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. Subjects will be given one 20 minute exposure to either the LFMS or sham electromagnetic field treatment.
| Study group | Role | What they receive |
|---|---|---|
| Active LFMS treatment | Active comparator | 20 minute exposure to the LFMS electromagnetic field treatment Receives: Device: Low Field Magnetic Stimulation Device |
| Sham LFMS treatment | Placebo comparator | 20 minute exposure to either the sham (inactive) electromagnetic field treatment Receives: Device: Low Field Magnetic Stimulation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montgomery-Asberg Depression Rating Scale (MADRS)score
MADRS scores will be compared between the baseline and week 3, one week after the final treatment.
Measured: at baseline and at week 3
Change in Positive-Negative Affect Scale (PANAS)score
PANAS scores will be compared between the baseline and week 3, one week after the final treatment.
Measured: at baseline and at one and at week 3
Secondary outcomes (3)
Immediate mood improvement as measured by the difference in post and pre treatment PANAS ratings
PANAS scores will be assessed at baseline and before and after each treatment. There are six treatments (Monday, Wednesday and Friday for two weeks).
Measured: at baseline and immediately before and after each treatment, 6 treatments across 2 weeks
Change in Montgomery-Asberg Depression Rating Scale (MADRS)score
MADRS scores will be compared between the baseline and week 4, two weeks after the final treatment.
Measured: at baseline and at week 4
Change in Positive-Negative Affect Scale (PANAS)score.
PANAS scores will be compared between the baseline and week 4, two weeks after the final treatment.
Measured: at baseline and at one and at week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startMay 2010
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Why it stopped: on hold indefinitely due to lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bipolar 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Rohan, Mclean Hospital
- Investigators
- Michael L. Rohan, Ph.D., Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557192
- Sponsor's protocol ID
- 2010-P-001097
- Acronym
- LFMS6tx
- Status last verified
- Apr 2016
- First submitted
- 14 Mar 2012
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Rohan M, Parow A, Stoll AL, Demopulos C, Friedman S, Dager S, Hennen J, Cohen BM, Renshaw PF. Low-field magnetic stimulation in bipolar depression using an MRI-based stimulator. Am J Psychiatry. 2004 Jan;161(1):93-8. doi: 10.1176/appi.ajp.161.1.93.
PubMed 14702256Carlezon WA Jr, Rohan ML, Mague SD, Meloni EG, Parsegian A, Cayetano K, Tomasiewicz HC, Rouse ED, Cohen BM, Renshaw PF. Antidepressant-like effects of cranial stimulation within a low-energy magnetic field in rats. Biol Psychiatry. 2005 Mar 15;57(6):571-6. doi: 10.1016/j.biopsych.2004.12.011.
PubMed 15780843
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Field Magnetic Stimulation in Mood Disorders in Six Visits
- ClinicalTrials.gov ID
- NCT01557192
- Acronym / sponsor ID
- LFMS6tx / 2010-P-001097
- Conditions
- Bipolar Depression, Unipolar Depression
- Keywords
- Depression, Bipolar Depression, LFMS, Electromagnetic Stimulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: on hold indefinitely due to lack of funding
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 19 Mar 2012 (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.
To demonstrate the efficacy of multiple applications of Low Field Magnetic Stimulation (LFMS) as an antidepressant treatment in subjects with mood disorders.
Detailed description
The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. The field and timing parameters of the LFMS pulses, such as pulse timing, duration, frequency, and electric and magnetic field distribution and direction are different from other neurostimulation methods.
The mechanism of action for the antidepressant effects of LFMS is hypothesized to be an effect on dendritic or synaptic activity in the cortex, brought about by low level electrical stimulation applied with particular timing. This is analogous to the synaptic effects of pharmaceutical antidepressants in providing a "boost" to synapses in certain brain regions.
Previous investigations of LFMS included depressed subjects with bipolar disorder. This study will evaluate the antidepressant effects of multiple LFMS treatments in bipolar disorder and major depressive disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active LFMS treatment | Active comparator | Device: Low Field Magnetic Stimulation Device20 minute exposure to the LFMS electromagnetic field treatment |
| Sham LFMS treatment | Placebo comparator | Device: Low Field Magnetic Stimulation Device20 minute exposure to either the sham (inactive) electromagnetic field treatment |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects MUST be significantly depressed, currently.
- Subjects must not have serious physical illnesses, neurological diseases or dementias.
- Subjects will meet DSM-IV criteria for Bipolar Disorder Type I or II, Major Depressive Disorder, Post Traumatic Stress Disorder, or Obsessive Compulsive Disorder, and be currently depressed.
- Subject must have a Ham-D score > 17, YMRS score < 7 (bipolar subjects only), and a MADRS score > 18.
- Subjects must be capable of providing informed consent.
Key exclusion criteria (5 listed)
- Dangerous or active suicidal ideation.
- Pregnant or planning on becoming pregnant.
- Substance abuse (cannot meet DSM criteria for substance abuse, no significant drug abuse within last 3 months, no major polysubstance abuse history, no history of dependence in last year, no drug use within last month).
- Mixed mood state or rapid cycling.
- Presence of a pacemaker, neurostimulator, or metal in head or neck.
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 |
|---|---|---|
| Low Field Magnetic Stimulation DeviceAlso: LFMSThe Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. Subjects will be given one 20 minute exposure to either the LFMS or sham electromagnetic field treatment. | Device | Active LFMS treatment, Sham LFMS treatment |
Primary outcome
Change in Montgomery-Asberg Depression Rating Scale (MADRS)score
Time frame: at baseline and at week 3
MADRS scores will be compared between the baseline and week 3, one week after the final treatment.
Change in Positive-Negative Affect Scale (PANAS)score
Time frame: at baseline and at one and at week 3
PANAS scores will be compared between the baseline and week 3, one week after the final treatment.
3 secondary outcomes
Immediate mood improvement as measured by the difference in post and pre treatment PANAS ratings
Time frame: at baseline and immediately before and after each treatment, 6 treatments across 2 weeks
Change in Montgomery-Asberg Depression Rating Scale (MADRS)score
Time frame: at baseline and at week 4
Change in Positive-Negative Affect Scale (PANAS)score.
Time frame: at baseline and at one and at week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- Results publication: PubMed 14702256Rohan M, Parow A, Stoll AL, Demopulos C, Friedman S, Dager S, Hennen J, Cohen BM, Renshaw PF. Low-field magnetic stimulation in bipolar depression using an MRI-based stimulator. Am J Psychiatry. 2004 Jan;161(1):93-8. doi: 10.1176/appi.ajp.161.1.93.
- Results publication: PubMed 15780843Carlezon WA Jr, Rohan ML, Mague SD, Meloni EG, Parsegian A, Cayetano K, Tomasiewicz HC, Rouse ED, Cohen BM, Renshaw PF. Antidepressant-like effects of cranial stimulation within a low-energy magnetic field in rats. Biol Psychiatry. 2005 Mar 15;57(6):571-6. doi: 10.1016/j.biopsych.2004.12.011.
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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.
Michael L. Rohan, Ph.D. principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low Field Magnetic Stimulation Device in people with Bipolar Depression and Unipolar Depression, run by Mclean Hospital 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 7 inclusion and 5 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: paused, as of the sponsor's last update on 13 Apr 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Change in Montgomery-Asberg Depression Rating Scale (MADRS)score (time frame: at baseline and at week 3). The study lists 2 primary outcomes in all. 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 NCT01557192, which also lists 2 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 13 Apr 2016.