Oxidative StressNCT02438748
Biological Markers of Treatment Response to Repetitive Transcranial Magnetic Stimulation for Depression
An observational study of Oxidative Stress, run by University of Manitoba at 1 site in Canada.
Trial summary
The main objective of this study is to determine whether biological stress markers (Oxidized Phosphatidylcholines and Oxylipins) in the blood can be used to predict the efficacy of rTMS in the treatment of major depressive disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- How many people
- 310 participants
- Where
- 1 siteCanada
- Study dates
- May 2015to May 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 250 patients with Major Depressive Disorder who have been deemed eligible for rTMS treatment. Eligible persons will be identified by a psychiatrist from among patients at the outpatient Neuromodulation and Neuropsychiatric Unit at St Boniface Hospital. 60 healthy control individuals.
Patient Inclusion Criteria:
- Patients with a major depressive episode
- Not actively receiving psychotherapy
Patient Exclusion Criteria:
- History of a psychotic episode
- History of neurological illness
- Head injury
- Active alcohol or substance abuse
- History of a seizure disorder
- Pregnant
Control Subject Exclusion Criteria:
- History of depression or psychiatric illness
- History of a psychotic episode
- History of neurological illness
- Head injury
- Active alcohol or substance abuse
- History of a seizure disorder
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Biological Stress Markers in Predicting Treatment Response to Repetitive Transcranial Magnetic Stimulation in Major Depressive Disorder
The main objective of this study is to determine whether biological stress markers (Oxidized Phosphatidylcholines and Oxylipins) in the blood can be used to predict the efficacy of rTMS in the treatment of major depressive disorder (MDD). It is our goal to identify biomarkers that may be used to determine which patients will benefit from rTMS treatment. A second objective of this study is to measure any changes in stress markers that occur across the course of rTMS therapy.
Read the detailed description
250 patients who have been prescribed repetitive transcranial magnetic stimulation (rTMS) therapy for the treatment of major depressive disorder will be recruited for this study. Prior to undergoing rTMS, patients will give a small blood sample. An additional blood sample will be given upon completion of rTMS treatment. 60 healthy control individuals will also be recruited to provide a one-time blood sample for comparison. Control individuals will not receive rTMS treatment.
Blood samples will be analysed for levels of Oxidized Phosphatidylcholines and Oxylipins. The investigators wish to determine whether there is a difference in the pre-treatment levels of stress markers between individuals who ultimately respond to rTMS and those who do not. Additionally, the investigators wish to determine whether there is a change in stress markers as a result of rTMS treatment.
- Conditions
- Oxidative Stress
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Keywords
- Oxidized Phosphatidylcholines, Oxylipins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
A non-invasive method of brain stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Individuals undergoing Repetitive Transcranial Magnetic Stimulation treatment for major depressive disorder. Receives: Device: Repetitive Transcranial Magnetic Stimulation | |
| Controls | Healthy age-, and sex-matched control individuals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oxidized Phosphatidylcholines in plasma
Change in Oxidized Phosphatidylcholine levels in blood plasma pre- and post-repetitive transcranial magnetic stimulation (rTMS) treatment for depression.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mandana Modirrousta, MD PhD FRCPC, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438748
- Sponsor's protocol ID
- B2014:102
- Status last verified
- Nov 2020
- First submitted
- 6 May 2015
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Biological Stress Markers in Predicting Treatment Response to Repetitive Transcranial Magnetic Stimulation in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02438748
- Acronym / sponsor ID
- B2014:102
- Conditions
- Oxidative Stress
- Keywords
- Oxidized Phosphatidylcholines, Oxylipins
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jan 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 8 May 2015 (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.
The main objective of this study is to determine whether biological stress markers (Oxidized Phosphatidylcholines and Oxylipins) in the blood can be used to predict the efficacy of rTMS in the treatment of major depressive disorder (MDD). It is our goal to identify biomarkers that may be used to determine which patients will benefit from rTMS treatment. A second objective of this study is to measure any changes in stress markers that occur across the course of rTMS therapy.
Detailed description
250 patients who have been prescribed repetitive transcranial magnetic stimulation (rTMS) therapy for the treatment of major depressive disorder will be recruited for this study. Prior to undergoing rTMS, patients will give a small blood sample. An additional blood sample will be given upon completion of rTMS treatment. 60 healthy control individuals will also be recruited to provide a one-time blood sample for comparison. Control individuals will not receive rTMS treatment.
Blood samples will be analysed for levels of Oxidized Phosphatidylcholines and Oxylipins. The investigators wish to determine whether there is a difference in the pre-treatment levels of stress markers between individuals who ultimately respond to rTMS and those who do not. Additionally, the investigators wish to determine whether there is a change in stress markers as a result of rTMS treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Device: Repetitive Transcranial Magnetic StimulationIndividuals undergoing Repetitive Transcranial Magnetic Stimulation treatment for major depressive disorder. |
| Controls | – | –Healthy age-, and sex-matched control individuals. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 250 patients with Major Depressive Disorder who have been deemed eligible for rTMS treatment. Eligible persons will be identified by a psychiatrist from among patients at the outpatient Neuromodulation and Neuropsychiatric Unit at St Boniface Hospital. 60 healthy control individuals.
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 |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationA non-invasive method of brain stimulation. | Device | Patients |
Primary outcome
Change in Oxidized Phosphatidylcholines in plasma
Time frame: 3 weeks
Change in Oxidized Phosphatidylcholine levels in blood plasma pre- and post-repetitive transcranial magnetic stimulation (rTMS) treatment for depression.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
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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.
Mandana Modirrousta, MD PhD FRCPC principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxidative Stress, run by University of Manitoba 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?
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: status not confirmed, as of the sponsor's last update on 4 Nov 2020. 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.
Are results available for this study?
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?
Change in Oxidized Phosphatidylcholines in plasma (time frame: 3 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 4 Nov 2020.