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

NCT ID: NCT02438748

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

310 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2022-05-31

Brief Summary

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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

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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

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Oxidative Stress

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Individuals undergoing Repetitive Transcranial Magnetic Stimulation treatment for major depressive disorder.

Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

A non-invasive method of brain stimulation.

Controls

Healthy age-, and sex-matched control individuals.

No interventions assigned to this group

Interventions

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Repetitive Transcranial Magnetic Stimulation

A non-invasive method of brain stimulation.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* History of a psychotic episode
* History of neurological illness
* Head injury
* Active alcohol or substance abuse
* History of a seizure disorder
* Pregnant


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mandana Modirrousta, MD PhD FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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St. Boniface Hospital

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Other Identifiers

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B2014:102

Identifier Type: -

Identifier Source: org_study_id