Clinical trial NCT02438748: Biological Markers of Treatment Response to Repetitive Transcranial Magnetic Stimulation for Depression
Official title: The Role of Biological Stress Markers in Predicting Treatment Response to Repetitive Transcranial Magnetic Stimulation in Major Depressive Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oxidative Stress
Keywords: Oxidized Phosphatidylcholines
Oxylipins
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2015-05-08
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Oxidized Phosphatidylcholines in plasma
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Mandana Modirrousta, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: