Bipolar DepressionPhase 3NCT00217217
Low Field Magnetic Stimulation Treatment for Bipolar Depression
A Phase 3 study testing Echo-Planar Magnetic Resonance Imaging (EP-MRSI) in people with Bipolar Depression and Bipolar Disorder, run by Mclean Hospital at 1 site in United States.
Trial summary
Individuals with bipolar depression who had a particular kind of brain imaging reported improved mood after the imaging. This effect may be linked to the changing magnetic fields used during these magnetic resonance imaging studies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bipolar Depression, Bipolar Disorder, Depression
- What is being tested?
- Echo-Planar Magnetic Resonance Imaging (EP-MRSI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jan 2012
- 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 of bipolar disorder.
- Current depression.
Who cannot join
- Contraindication for MRI due to metal in eyes/head
- Claustrophobia.
- Inability to lie flat.
- History of brain injury.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Field Magnetic Stimulation in Bipolar Depression
Individuals with bipolar depression who had a particular kind of brain imaging reported improved mood after the imaging. This effect may be linked to the changing magnetic fields used during these magnetic resonance imaging studies. The current studies are designed to further explore the important parameters of this effect and to clarify the degree and duration of the mood effects.
Read the detailed description
An initial study using proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) in bipolar depressed individuals was associated with reports of improved mood. These studies employed oscillating magnetic fields similar to those used in functional MRI (fMRI), but which differ from the usual fMRI scan in field direction, waveform frequency, and strength. As the abbreviation EP-MRSI is used to describe several relatively common MR sequences, the specific potential clinical procedure being used is referred to as low field magnetic stimulation or LFMS. Following these initial results, investigators are conducting studies to determine the critical variables in both subjects and treatment for optimal response. Studies are also underway to characterize the response of specific depression symptoms, the degree of response, and the duration of response.
- Conditions
- Bipolar Depression, Bipolar Disorder, Depression
- Being tested
- Echo-Planar Magnetic Resonance Imaging (EP-MRSI)
- Keywords
- non-pharmaceutical, alternative, imaging, magnetic resonance imaging, low field magnetic stimulation, bipolar disorder, depression, bipolar depression
- Medical subject headings
- Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echo-Planar Magnetic Resonance Imaging (EP-MRSI)Device
Also called Low Field Magnetic Stimulation (LFMS)
variable-setting low-frequency MRI
| Study group | Role | What they receive |
|---|---|---|
| Active EEP-MRSI treatment | Experimental | 20 minutes of active treatment with theEcho-Planar Magnetic Resonance Imaging (EP-MRSI) Receives: Device: Echo-Planar Magnetic Resonance Imaging (EP-MRSI) |
| Sham comparator EP-MRSI | Sham comparator | Sham treatment (20 minutes) with the Echo-Planar Magnetic Resonance Imaging (EP-MRSI). Receives: Device: Echo-Planar Magnetic Resonance Imaging (EP-MRSI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Affect Scale
Measured: pre/post-treatment
Secondary outcomes (2)
Visual-Analog Scales
Measured: pre/post-treatment
Montgomery Asberg Depression Rating Scale (MADRS)
Measured: pre-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionDec 2011
- Study completionJan 2012
Why it stopped: Study was terminated for lack of recruitment.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Responsible party
- Principal investigator, Michael Rohan, Mclean Hospital
- Investigators
- Michael Rohan, MS, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00217217
- Sponsor's protocol ID
- 2004P-002631
- Status last verified
- Mar 2012
- First submitted
- 15 Sep 2005
- Last updated
- 14 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Carlezon 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 15780843Rohan 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 14702256
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Field Magnetic Stimulation in Bipolar Depression
- ClinicalTrials.gov ID
- NCT00217217
- Acronym / sponsor ID
- 2004P-002631
- Conditions
- Bipolar Depression, Bipolar Disorder, Depression
- Keywords
- non-pharmaceutical, alternative, imaging, magnetic resonance imaging, low field magnetic stimulation, bipolar disorder, depression, bipolar depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated for lack of recruitment.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Study start
- Sep 2004
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 22 Sep 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.
Individuals with bipolar depression who had a particular kind of brain imaging reported improved mood after the imaging. This effect may be linked to the changing magnetic fields used during these magnetic resonance imaging studies. The current studies are designed to further explore the important parameters of this effect and to clarify the degree and duration of the mood effects.
Detailed description
An initial study using proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) in bipolar depressed individuals was associated with reports of improved mood. These studies employed oscillating magnetic fields similar to those used in functional MRI (fMRI), but which differ from the usual fMRI scan in field direction, waveform frequency, and strength. As the abbreviation EP-MRSI is used to describe several relatively common MR sequences, the specific potential clinical procedure being used is referred to as low field magnetic stimulation or LFMS. Following these initial results, investigators are conducting studies to determine the critical variables in both subjects and treatment for optimal response. Studies are also underway to characterize the response of specific depression symptoms, the degree of response, and the duration of response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active EEP-MRSI treatment | Experimental | Device: Echo-Planar Magnetic Resonance Imaging (EP-MRSI)20 minutes of active treatment with theEcho-Planar Magnetic Resonance Imaging (EP-MRSI) |
| Sham comparator EP-MRSI | Sham comparator | Device: Echo-Planar Magnetic Resonance Imaging (EP-MRSI)Sham treatment (20 minutes) with the Echo-Planar Magnetic Resonance Imaging (EP-MRSI). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary diagnosis of bipolar disorder.
- Current depression.
Key exclusion criteria (4 listed)
- Contraindication for MRI due to metal in eyes/head
- Claustrophobia.
- Inability to lie flat.
- History of brain injury.
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 |
|---|---|---|
| Echo-Planar Magnetic Resonance Imaging (EP-MRSI)Also: Low Field Magnetic Stimulation (LFMS)variable-setting low-frequency MRI | Device | Active EEP-MRSI treatment, Sham comparator EP-MRSI |
Primary outcome
Positive and Negative Affect Scale
Time frame: pre/post-treatment
2 secondary outcomes
Visual-Analog Scales
Time frame: pre/post-treatment
Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: pre-treatment
Results and safety
The study was stopped early (reason given: Study was terminated for lack of recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2012.
- Background: 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.
- 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.
- Web site for McLean hospital with links to research pages.Link provided by the sponsor.
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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 Rohan, MS 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 3 study testing Echo-Planar Magnetic Resonance Imaging (EP-MRSI) in people with Bipolar Depression and Bipolar Disorder, 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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 14 Mar 2012. 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 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 was stopped early (reason given: Study was terminated for lack of recruitment.). 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?
Positive and Negative Affect Scale (time frame: pre/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 NCT00217217, 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 14 Mar 2012.