Bipolar DepressionPhase 1/2NCT00470639
Transcranial Magnetic Stimulation for Bipolar Depression
A Phase 1/2 study testing Transcranial Magnetic Stimulation in people with Bipolar Depression, run by The University of New South Wales at 2 sites in Australia.
Trial summary
This is a study to assess the effectiveness of repetitive transcranial magnetic stimulation (rTMS) as a treatment for depressed adults with bipolar disorder. In rTMS high-intensity, fluctuating magnetic fields non-invasively stimulate the cortex of the brain depolarising neurons. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesAustralia
- Study dates
- Apr 2007to Dec 2008
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV Major Depressive Episode of no more than 3 years.
- Diagnosis of bipolar I or II disorder
- Montgomery-Asberg Depression Rating Scale score of 20 or more.
- Aged over 18
- May or may not be taking antidepressant medication.
Who cannot join
- Patient not able to give informed consent.
- Failure to respond to ECT in current episode of depression.
- Significant other Axis I psychiatric disorders e.g. schizophrenia.
- In imminent physical or psychological danger, or needs rapid clinical response due to inanition, psychosis or high suicide risk.
- Comorbid substance abuse or dependence
- History of neurological illness e.g. epilepsy; neurosurgical procedure
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- Metal in the cranium, a pacemaker, cochlear implant, medication pump or other electronic device.
- Women of child-bearing age in whom pregnancy cannot be ruled out.
- Patients with a history of mood 'switching' in response to other treatments.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Black Dog Research Institute
Sydney, New South Wales
Northside Clinic
Sydney, New South Wales
About this study
Official title: A Comparison of Left vs. Right Prefrontal Cortex Transcranial Magnetic Stimulation as a Treatment for Bipolar Depression
This is a study to assess the effectiveness of repetitive transcranial magnetic stimulation (rTMS) as a treatment for depressed adults with bipolar disorder.
In rTMS high-intensity, fluctuating magnetic fields non-invasively stimulate the cortex of the brain depolarising neurons. No anaesthetic is required and the treatment in subconvulsive. Recent studies suggest that rTMS can be an effective treatment for depressive illness in adults (Loo and Mitchell et al, 2005) and appears to be quite safe.
Read more
Most of the published studies to date have focused on unipolar depression. There is limited data of TMS use in bipolar depression. Eg. Pilot study by Nahas Z, Kozel FA, Li X, Anderson B, George MS.in 2003, which was negative.
The investigators wish to assess this in a sham-controlled study of adults. The investigators hypothesise that both left and right sided rTMS will have an antidepressant effect superior to sham in this population.
Read the detailed description
Inpatients and outpatients with major depressive episodes as part of either bipolar I or II illness will be eligible. In the event that patients (in any arm) have no significant response after a defined period, they will shift to an open phase where they will receive left prefrontal 10Hz stimulation. Thus all participants will have the opportunity to receive active treatment.
- Conditions
- Bipolar Depression
- Being tested
- Transcranial Magnetic Stimulation
- Keywords
- TMS, Treatment, Bipolar, Efficacy
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TMS | Experimental | Not described Receives: Device: Transcranial Magnetic Stimulation |
| Sham | Sham comparator | Not described Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
All measures at baseline and at the end of each week of treatment in the blind phase and after every 2 weeks of treatment in the open phase.
Measured: weekly
Montgomery-Asberg Depression Rating Scale (MADRS)
Measured: Weekly
Clinical Global Impressions Scale (CGI)
Measured: Weekly
Secondary outcomes (2)
Patient Global Improvement scale
Measured: Weekly
Young Mania Rating Scale
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2007 (estimated)
- Study startApr 2007
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Poor 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colleen Loo, The University of New South Wales
- Investigators
- Colleen Loo, FRANZCP, MD, Principal investigator, University of New South WalesWilliam Lyndon, FRANZCP, Study director, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470639
- Sponsor's protocol ID
- 07103
- Status last verified
- Mar 2023
- First submitted
- 7 May 2007
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Nahas Z, Kozel FA, Li X, Anderson B, George MS. Left prefrontal transcranial magnetic stimulation (TMS) treatment of depression in bipolar affective disorder: a pilot study of acute safety and efficacy. Bipolar Disord. 2003 Feb;5(1):40-7. doi: 10.1034/j.1399-5618.2003.00011.x.
PubMed 12656937Loo CK, Mitchell PB. A review of the efficacy of transcranial magnetic stimulation (TMS) treatment for depression, and current and future strategies to optimize efficacy. J Affect Disord. 2005 Nov;88(3):255-67. doi: 10.1016/j.jad.2005.08.001. Epub 2005 Sep 2.
PubMed 16139895
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Left vs. Right Prefrontal Cortex Transcranial Magnetic Stimulation as a Treatment for Bipolar Depression
- ClinicalTrials.gov ID
- NCT00470639
- Acronym / sponsor ID
- 07103
- Conditions
- Bipolar Depression
- Keywords
- TMS, Treatment, Bipolar, Efficacy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Poor recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Study start
- Apr 2007 (actual)
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 8 May 2007 (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 is a study to assess the effectiveness of repetitive transcranial magnetic stimulation (rTMS) as a treatment for depressed adults with bipolar disorder.
In rTMS high-intensity, fluctuating magnetic fields non-invasively stimulate the cortex of the brain depolarising neurons. No anaesthetic is required and the treatment in subconvulsive. Recent studies suggest that rTMS can be an effective treatment for depressive illness in adults (Loo and Mitchell et al, 2005) and appears to be quite safe.
Most of the published studies to date have focused on unipolar depression. There is limited data of TMS use in bipolar depression. Eg. Pilot study by Nahas Z, Kozel FA, Li X, Anderson B, George MS.in 2003, which was negative.
The investigators wish to assess this in a sham-controlled study of adults. The investigators hypothesise that both left and right sided rTMS will have an antidepressant effect superior to sham in this population.
Detailed description
Inpatients and outpatients with major depressive episodes as part of either bipolar I or II illness will be eligible. In the event that patients (in any arm) have no significant response after a defined period, they will shift to an open phase where they will receive left prefrontal 10Hz stimulation. Thus all participants will have the opportunity to receive active treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMS | Experimental | Device: Transcranial Magnetic Stimulation |
| Sham | Sham comparator | Device: Transcranial Magnetic Stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- DSM-IV Major Depressive Episode of no more than 3 years.
- Diagnosis of bipolar I or II disorder
- Montgomery-Asberg Depression Rating Scale score of 20 or more.
- Aged over 18
- May or may not be taking antidepressant medication.
Key exclusion criteria (9 listed)
- Patient not able to give informed consent.
- Failure to respond to ECT in current episode of depression.
- Significant other Axis I psychiatric disorders e.g. schizophrenia.
- In imminent physical or psychological danger, or needs rapid clinical response due to inanition, psychosis or high suicide risk.
- Comorbid substance abuse or dependence
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 |
|---|---|---|
| Transcranial Magnetic Stimulation | Device | Sham, TMS |
Primary outcome
All measures at baseline and at the end of each week of treatment in the blind phase and after every 2 weeks of treatment in the open phase.
Time frame: weekly
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Weekly
Clinical Global Impressions Scale (CGI)
Time frame: Weekly
2 secondary outcomes
Patient Global Improvement scale
Time frame: Weekly
Young Mania Rating Scale
Time frame: weekly
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Background: PubMed 12656937Nahas Z, Kozel FA, Li X, Anderson B, George MS. Left prefrontal transcranial magnetic stimulation (TMS) treatment of depression in bipolar affective disorder: a pilot study of acute safety and efficacy. Bipolar Disord. 2003 Feb;5(1):40-7. doi: 10.1034/j.1399-5618.2003.00011.x.
- Background: PubMed 16139895Loo CK, Mitchell PB. A review of the efficacy of transcranial magnetic stimulation (TMS) treatment for depression, and current and future strategies to optimize efficacy. J Affect Disord. 2005 Nov;88(3):255-67. doi: 10.1016/j.jad.2005.08.001. Epub 2005 Sep 2.
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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.
Colleen Loo, FRANZCP, MD principal investigator
University of New South Wales
William Lyndon, FRANZCP study director
University of Sydney
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Transcranial Magnetic Stimulation in people with Bipolar Depression, run by The University of New South Wales at 2 sites in Australia.
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 5 inclusion and 9 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: withdrawn, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. 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 combined 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
All measures at baseline and at the end of each week of treatment in the blind phase and after every 2 weeks of treatment in the open phase. (time frame: weekly). The study lists 3 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 NCT00470639, 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 3 Apr 2023.