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

• Conditions: Oxidative Stress
• Interventions: Device: Repetitive Transcranial Magnetic Stimulation

• Registration Number: NCT02438748
• Lead Sponsor: University of Manitoba

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-06
• Study First Submitted QC: 2015-05-06
• Study First Posted: 2015-05-08
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-04
• Primary Completion: 2022-01
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

• Patients with a major depressive episode
• Not actively receiving psychotherapy

Patient

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Repetitive Transcranial Magnetic Stimulation	Individuals undergoing Repetitive Transcranial Magnetic Stimulation treatment for major depressive disorder.

Primary Outcome Measures

Name	Time	Method
Change in Oxidized Phosphatidylcholines in plasma	3 weeks	Change in Oxidized Phosphatidylcholine levels in blood plasma pre- and post-repetitive transcranial magnetic stimulation (rTMS) treatment for depression.

Trial Locations

Locations (1)

St. Boniface Hospital; 🇨🇦 Winnipeg, Manitoba, Canada