Mood DisorderTMS-BDNCT00699218
A Pilot Study on Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment of Bipolar Depression
A study testing Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K. in people with Mood Disorder and Bipolar Disorder, run by University of California, Davis at 1 site in United States.
Trial summary
This is a pilot project to study if repetitive Transcranial Magnetic Stimulation (rTMS) will benefit patients with bipolar depression safely. Based on published studies, this study hypothesizes that rTMS on the left dorsal prefrontal lobe will improve symptoms in some patients who have failed at least two medications. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mood Disorder, Bipolar Disorder, Major Depression
- What is being tested?
- Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Apr 2010
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- bipolar I or II patients, currently in a depression episode
- Patient must have failed at least 2 medication
- Score of 21-item Hamilton Rating Scale for Depression (HAM-D)
Who cannot join
- Rapid cycling bipolar or mixed episode of mood disorder by definition of current DSM criteria
- Substantial risk of suicide during the screening period that requires inpatient care
- Presence of psychosis
- Dual diagnosis of other primary, currently clinically significant severe mental disorders
- History of other significant neurological diseases, such as seizure disorder, stroke, brain tumors, abnormalities in the blood vessels in brain, dementia, Parkinson's disease, Huntington's chorea or multiple sclerosis
- History of any medical event that may increase the risk of having seizure, such as head trauma with unconsciousness for more than 5 minutes or a family history of seizure
Show all 13Show fewer
- Significant medical complications that may deteriorate during the trial or have increased likelihood of danger consequences
- Patients who are pregnant or intend to become pregnant during the study period
- Any metallic prosthesis in head, neck or upper body (including cardiac pace maker) that cannot be safely removed during treatment
- Current Vagus Nerve Stimulation (VNS) treatment or Electroconvulsive Therapy (ECT) treatment, or with history of failed ECT treatment
- Patient's Motor Threshold for TMS cannot be detected
- Significant side effects which are intolerable during the screening or any later stage of the trial
- Started psychotherapy within the previous 8 weeks or foreseeable psychotherapy will be started or changed in 6 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study on Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment of Bipolar Depression
This is a pilot project to study if repetitive Transcranial Magnetic Stimulation (rTMS) will benefit patients with bipolar depression safely. Based on published studies, this study hypothesizes that rTMS on the left dorsal prefrontal lobe will improve symptoms in some patients who have failed at least two medications.
Read the detailed description
Candidate with bipolar depression will be screened after signing informed consent. Those who meet the selection criteria will be treated with daily rTMS for 3 weeks and be followed-up at 2 weeks. Participants will keep their ongoing medication unless a medication significantly increases the possibility of seizure. They must be on the same dose of antidepressant medication for least 4 weeks without improvement of symptoms before being recruited into the study. Mood and other observed mental status will be measured by standard psychological scales.
- Conditions
- Mood Disorder, Bipolar Disorder, Major Depression, Depression
- Being tested
- Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.
- Keywords
- Bipolar, Depression, TMS, repetitive Transcranial Magnetic Stimulation, treatment, Efficacy, Safety
- Medical subject headings
- Mood Disorders, Bipolar Disorder, Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.Device
Also called Repetitive Transcranial Magnetic Stimulation (rTMS)
High frequency repetitive TMS given daily on weekdays for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| rTMS treatment | Experimental | Active rTMS treatment. Transcranial magnetic stimulation using a device called MagStim Receives: Device: Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression (HAM-D)
Scored Questionnaire 0-52, A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression. The higher score means more severe depression.
Measured: 5 weeks
Secondary outcomes (1)
Inventory of Depressive Symptomatology
Self reported depression scale range 0-84. Questionnaire administered at 1,2, and 3 weeks (end of treatment). We also did a 5 week follow-up. The higher scores indicate greater or more severe depression.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2009
- Study completionApr 2010
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 Mood DisorderStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Responsible party
- Sponsor
- Investigators
- Guohua Xia, M.D., Ph.D., Principal investigator, Department of Psychiatry and Behavioral Sciences, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699218
- Sponsor's protocol ID
- 200715749
- Acronym
- TMS-BD
- Status last verified
- Oct 2017
- First submitted
- 4 Jun 2008
- Last updated
- 23 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment of Bipolar Depression
- ClinicalTrials.gov ID
- NCT00699218
- Acronym / sponsor ID
- TMS-BD / 200715749
- Conditions
- Mood Disorder, Bipolar Disorder, Major Depression, Depression
- Keywords
- Bipolar, Depression, TMS, repetitive Transcranial Magnetic Stimulation, treatment, Efficacy, Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Study start
- May 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 17 Jun 2008 (estimated)
- Results
- Posted 23 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot project to study if repetitive Transcranial Magnetic Stimulation (rTMS) will benefit patients with bipolar depression safely. Based on published studies, this study hypothesizes that rTMS on the left dorsal prefrontal lobe will improve symptoms in some patients who have failed at least two medications.
Detailed description
Candidate with bipolar depression will be screened after signing informed consent. Those who meet the selection criteria will be treated with daily rTMS for 3 weeks and be followed-up at 2 weeks. Participants will keep their ongoing medication unless a medication significantly increases the possibility of seizure. They must be on the same dose of antidepressant medication for least 4 weeks without improvement of symptoms before being recruited into the study. Mood and other observed mental status will be measured by standard psychological scales.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rTMS treatment | Experimental | Device: Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.Active rTMS treatment. Transcranial magnetic stimulation using a device called MagStim |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- bipolar I or II patients, currently in a depression episode
- Patient must have failed at least 2 medication
- Score of 21-item Hamilton Rating Scale for Depression (HAM-D)
Key exclusion criteria (13 listed)
- Rapid cycling bipolar or mixed episode of mood disorder by definition of current DSM criteria
- Substantial risk of suicide during the screening period that requires inpatient care
- Presence of psychosis
- Dual diagnosis of other primary, currently clinically significant severe mental disorders
- History of other significant neurological diseases, such as seizure disorder, stroke, brain tumors, abnormalities in the blood vessels in brain, dementia, Parkinson's disease, Huntington's chorea or multiple sclerosis
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 |
|---|---|---|
| Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.Also: Repetitive Transcranial Magnetic Stimulation (rTMS)High frequency repetitive TMS given daily on weekdays for 3 weeks | Device | rTMS treatment |
Primary outcome
Hamilton Rating Scale for Depression (HAM-D)
Time frame: 5 weeks
Scored Questionnaire 0-52, A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression. The higher score means more severe depression.
1 secondary outcome
Inventory of Depressive Symptomatology
Time frame: 5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- PI facilitationLink provided by the sponsor.
- Dr. Xia's blog briefly introducing the trialLink 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.
Guohua Xia, M.D., Ph.D. principal investigator
Department of Psychiatry and Behavioral Sciences, UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K. in people with Mood Disorder and Bipolar Disorder, run by University of California, Davis 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 13 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 23 Jul 2018. 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. 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 23 Jul 2018). 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?
Hamilton Rating Scale for Depression (HAM-D) (time frame: 5 weeks). 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 23 Jul 2018.