Unipolar DepressionEarly Phase 1NCT00186784
Transcranial Magnetic Treatment (TMS) in Unipolar Depression
A Early Phase 1 study testing Transcranial Magnetic Stimulation (TMS) in people with Unipolar Depression, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
Repetitive Transcranial Magnetic Stimulation (rTMS) can improve mood and decrease sadness in patients with depression. In this study, the investigators seek to increase their understanding about how rTMS improves depression, and to determine which form of rTMS is most effective for depression, when used in combination… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Unipolar Depression
- What is being tested?
- Transcranial Magnetic Stimulation (TMS)
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2000to Jul 2011
- Phase
- Early 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major Depression
- No physical health problems
Who cannot join
- History of Epilepsy
- Metal in the head/neck or skull
- Pacemaker
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Canada1 site
St.Joseph's Healthcare, rTMS Laboratory, Mood Disorders Program, 100 West Fifth Street
Hamilton, Ontario, L8N 3K7
About this study
Official title: Repetitive Transcranial Magnetic Stimulation (rTMS) in Unipolar Depression
Repetitive Transcranial Magnetic Stimulation (rTMS) can improve mood and decrease sadness in patients with depression.
In this study, the investigators seek to increase their understanding about how rTMS improves depression, and to determine which form of rTMS is most effective for depression, when used in combination with antidepressant medication.
Read the detailed description
Patients will be assigned for 4 treatment arms, receiving either left high frequency plus right low frequency, or left high frequency plus right sham, or left sham, plus right low frequency, or left sham plus right sham treatment. All subjects will receive treatments for 10 days and will be followed for another 4 weeks.
- Conditions
- Unipolar Depression
- Being tested
- Transcranial Magnetic Stimulation (TMS)
- Keywords
- Repetitive Transcranial Magnetic Stimulation, TMS
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS)Procedure or surgery
treatment for 10 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale
Measured: Pre TMS and post TMS
Beck Depression Rating Scale
Measured: pre TMS and post TMS
Secondary outcomes (1)
Quantitive Electroencephalographic(QEEG)activity and measures of regional cerebral blood flow
Measured: pre TMS and post TMS as well as post phase II, second set of TMS
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 startDec 2000
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unipolar 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
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
- NCT00186784
- Sponsor's protocol ID
- TMS1871
- Status last verified
- Aug 2011
- First submitted
- 13 Sep 2005
- Last updated
- 3 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Jacquot F, Khoury S, Labrum B, Delanoe K, Pidoux L, Barbier J, Delay L, Bayle A, Aissouni Y, Barriere DA, Kultima K, Freyhult E, Hugo A, Kosek E, Ahmed AS, Jurczak A, Lingueglia E, Svensson CI, Breuil V, Ferreira T, Marchand F, Deval E. Lysophosphatidylcholine 16:0 mediates chronic joint pain associated to rheumatic diseases through acid-sensing ion channel 3. Pain. 2022 Oct 1;163(10):1999-2013. doi: 10.1097/j.pain.0000000000002596. Epub 2022 Jan 27.
PubMed 35086123
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
- Repetitive Transcranial Magnetic Stimulation (rTMS) in Unipolar Depression
- ClinicalTrials.gov ID
- NCT00186784
- Acronym / sponsor ID
- TMS1871
- Conditions
- Unipolar Depression
- Keywords
- Repetitive Transcranial Magnetic Stimulation, TMS
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- Queen's University, Kingston, Ontario
- Study start
- Dec 2000
- 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.
Repetitive Transcranial Magnetic Stimulation (rTMS) can improve mood and decrease sadness in patients with depression.
In this study, the investigators seek to increase their understanding about how rTMS improves depression, and to determine which form of rTMS is most effective for depression, when used in combination with antidepressant medication.
Detailed description
Patients will be assigned for 4 treatment arms, receiving either left high frequency plus right low frequency, or left high frequency plus right sham, or left sham, plus right low frequency, or left sham plus right sham treatment. All subjects will receive treatments for 10 days and will be followed for another 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Major Depression
- No physical health problems
Key exclusion criteria (4 listed)
- History of Epilepsy
- Metal in the head/neck or skull
- Pacemaker
- Pregnancy
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)treatment for 10 days | Procedure or surgery | – |
Primary outcome
Hamilton Depression Rating Scale
Time frame: Pre TMS and post TMS
Beck Depression Rating Scale
Time frame: pre TMS and post TMS
1 secondary outcome
Quantitive Electroencephalographic(QEEG)activity and measures of regional cerebral blood flow
Time frame: pre TMS and post TMS as well as post phase II, second set of TMS
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.
- Derived from this study: PubMed 35086123Jacquot F, Khoury S, Labrum B, Delanoe K, Pidoux L, Barbier J, Delay L, Bayle A, Aissouni Y, Barriere DA, Kultima K, Freyhult E, Hugo A, Kosek E, Ahmed AS, Jurczak A, Lingueglia E, Svensson CI, Breuil V, Ferreira T, Marchand F, Deval E. Lysophosphatidylcholine 16:0 mediates chronic joint pain associated to rheumatic diseases through acid-sensing ion channel 3. Pain. 2022 Oct 1;163(10):1999-2013. doi: 10.1097/j.pain.0000000000002596. Epub 2022 Jan 27.
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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 Early Phase 1 study testing Transcranial Magnetic Stimulation (TMS) in people with Unipolar Depression, 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Hamilton Depression Rating Scale (time frame: Pre TMS and post TMS). 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 NCT00186784, which also lists 1 linked publication.
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.