- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02438748
Biological Markers of Treatment Response to Repetitive Transcranial Magnetic Stimulation for Depression
The Role of Biological Stress Markers in Predicting Treatment Response to Repetitive Transcranial Magnetic Stimulation in Major Depressive Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Manitoba
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Winnipeg, Manitoba, Canada, R3P2B4
- St. Boniface Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients
Individuals undergoing Repetitive Transcranial Magnetic Stimulation treatment for major depressive disorder.
|
A non-invasive method of brain stimulation.
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Controls
Healthy age-, and sex-matched control individuals.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- B2014:102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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