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NCT02438748 Clinical Trial

Biological Markers of Treatment Response to Repetitive Transcranial Magnetic Stimulation for Depression

Oxidative Stress Clinical Trial

Official title:
The Role of Biological Stress Markers in Predicting Treatment Response to Repetitive Transcranial Magnetic Stimulation in Major Depressive Disorder

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02438748
Other study ID # B2014:102
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date May 2015
Est. completion date May 2022

Study information
Verified date November 2020
Source University of Manitoba
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 310
Est. completion date May 2022
Est. primary completion date January 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation
A non-invasive method of brain stimulation.

Locations
Country Name City State
Canada St. Boniface Hospital Winnipeg Manitoba

Sponsors (1)
Lead Sponsor Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 3 weeks
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