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

NCT02438748 | Unknown

• 1 other identifier: B2014:102
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxidative Stress

Keywords

Oxidized Phosphatidylcholines; Oxylipins

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patients

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

Device: Repetitive Transcranial Magnetic Stimulation

Controls

Healthy age-, and sex-matched control individuals.

Interventions

Repetitive Transcranial Magnetic Stimulation DEVICE

A non-invasive method of brain stimulation.

Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

St. Boniface Hospital

Winnipeg, Manitoba, R3P2B4, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

10ml of blood will be extracted at each collection. Patients will give two samples. Controls will give one sample. Following collection, blood samples will be spun to separate and extract plasma. The amount of oxidized phosphatidylcholines in the plasma will then be quantified.

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Mandana Modirrousta, MD PhD FRCPC

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: May 8, 2015
• Study Start: May 1, 2015
• Primary Completion: January 1, 2022
• Study Completion: May 1, 2022
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

CA (1)