Bipolar Affective DisorderPhase 4TMSNCT00186758
Transcranial Magnetic Stimulation in Bipolar Depression
A Phase 4 study testing Transcranial Magnetic Stimulation (TMS) in people with Bipolar Affective Disorder, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
To compare antidepressant efficacy of left or right to sham Repetitive Transcranial Magnetic Stimulation (rTMS) to determine if non-responders can become responders if treated on the other side of the hemisphere (rTMS) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Affective Disorder
- What is being tested?
- Transcranial Magnetic Stimulation (TMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2002to Jul 2011
- Phase
- Phase 4
- 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
- Bipolar Depression
- no physical health problems
Who cannot join
- Metal in head/neck or skull
- History of Epilepsy
- Pregnancy
- Pacemaker
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Joseph's Healthcare, rTMS Laboratory, Mood Disorder Program, 100 West Fifth Street
Hamilton, Ontario, L8N 3K7
About this study
Official title: A Randomized, Sham Controlled, Crossover Trial of rTMS for Bipolar Depression
To compare antidepressant efficacy of left or right to sham Repetitive Transcranial Magnetic Stimulation (rTMS)
to determine if non-responders can become responders if treated on the other side of the hemisphere
(rTMS)
Read the detailed description
Patients will be assigned to one of 3 treatment arms for 10 days of treatment with either left high frequency or right high frequency, or sham rTMS. After 10 days of treatment, and no improvement, another 10 days of treatment follows, this time with the coil placed on the other hemisphere. Subjects will be followed for 2 months respectively with unrestricted treatment provided by their regular physician. Mood stabilizers will be continued throughout this trial.
- Conditions
- Bipolar Affective Disorder
- Being tested
- Transcranial Magnetic Stimulation (TMS)
- Keywords
- Transcranial Magnetic Stimulation, TMS
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS)Device
Also called HamD, BDI II, VAS
Phase l clients receive either True or Sham TMS treatments on left or right side of head for 10 days.
Phase ll clients will receive either Sham or True TMS treatments on the other side of the head - the same type as in phase l -
| Study group | Role | What they receive |
|---|---|---|
| 1, Phase l, True or Sham | Sham comparator | this treatment will be True or Sham (placebo) on one side of the head, phase I Receives: Device: Transcranial Magnetic Stimulation (TMS) |
| 2, phase ll, Sham or True | Active comparator | This treatment will be Sham(placebo)or True on the other side of the head phase II. Receives: Device: Transcranial Magnetic Stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare antidepressant efficacy of right, left to sham
Measured: within 9 weeks
Secondary outcomes (2)
To determine if QEEG activity correlates with antidepressant response to rTMS
Measured: within 9 weeks
To determine if non-responders can become responders if treating the opposite hemisphere
Measured: within 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJul 2002
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Affective DisorderStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University, Kingston, Ontario
- Investigators
- Gary Hasey, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00186758
- Sponsor's protocol ID
- TMS2092
- Acronym
- TMS
- Status last verified
- Aug 2011
- First submitted
- 13 Sep 2005
- Last updated
- 3 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Sham Controlled, Crossover Trial of rTMS for Bipolar Depression
- ClinicalTrials.gov ID
- NCT00186758
- Acronym / sponsor ID
- TMS / TMS2092
- Conditions
- Bipolar Affective Disorder
- Keywords
- Transcranial Magnetic Stimulation, TMS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- Queen's University, Kingston, Ontario
- Study start
- Jul 2002
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 16 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.
To compare antidepressant efficacy of left or right to sham Repetitive Transcranial Magnetic Stimulation (rTMS)
to determine if non-responders can become responders if treated on the other side of the hemisphere
(rTMS)
Detailed description
Patients will be assigned to one of 3 treatment arms for 10 days of treatment with either left high frequency or right high frequency, or sham rTMS. After 10 days of treatment, and no improvement, another 10 days of treatment follows, this time with the coil placed on the other hemisphere. Subjects will be followed for 2 months respectively with unrestricted treatment provided by their regular physician. Mood stabilizers will be continued throughout this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1, Phase l, True or Sham | Sham comparator | Device: Transcranial Magnetic Stimulation (TMS)this treatment will be True or Sham (placebo) on one side of the head, phase I |
| 2, phase ll, Sham or True | Active comparator | Device: Transcranial Magnetic Stimulation (TMS)This treatment will be Sham(placebo)or True on the other side of the head phase II. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Bipolar Depression
- no physical health problems
Key exclusion criteria (4 listed)
- Metal in head/neck or skull
- History of Epilepsy
- Pregnancy
- Pacemaker
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 (TMS)Also: HamD, BDI II, VASPhase l clients receive either True or Sham TMS treatments on left or right side of head for 10 days. Phase ll clients will receive either Sham or True TMS treatments on the other side of the head - the same type as in phase l - | Device | 1, Phase l, True or Sham, 2, phase ll, Sham or True |
Primary outcome
To compare antidepressant efficacy of right, left to sham
Time frame: within 9 weeks
2 secondary outcomes
To determine if QEEG activity correlates with antidepressant response to rTMS
Time frame: within 9 weeks
To determine if non-responders can become responders if treating the opposite hemisphere
Time frame: within 9 weeks
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 3 Aug 2011.
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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.
Gary Hasey, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transcranial Magnetic Stimulation (TMS) in people with Bipolar Affective Disorder, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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: finished, as of the sponsor's last update on 3 Aug 2011. 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 Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
To compare antidepressant efficacy of right, left to sham (time frame: within 9 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 3 Aug 2011.