Biological Markers of Treatment Response to Repetitive Tr... | NCT02438748

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

NCT02438748

Sponsor

University of Manitoba

Status

Unknown status

Last Update Posted

Nov 4, 2020Actual

Enrollment

310Estimated

Phase

Not provided

Conditions

Oxidative Stress

Interventions

Repetitive Transcranial Magnetic Stimulation

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

Jan 2022Estimated

Completion Date

May 2022Estimated

First Submitted Date

May 6, 2015

First Submission Date that Met QC Criteria

May 6, 2015

First Posted Date

May 8, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2020

Last Update Posted Date

Nov 4, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

310Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Repetitive Transcranial Magnetic Stimulation	Device	A non-invasive method of brain stimulation.	Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mandana Modirrousta, MD PhD FRCPC	University of Manitoba	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Boniface Hospital		Winnipeg	Manitoba	R3P2B4	Canada

Type	Date	Date Unknown
Release	Oct 1, 2021
Reset	Oct 29, 2021

Submission Tracking

Estimated Results First Submitted Date

Oct 1, 2021

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 1, 2021			Oct 29, 2021

Intervention Browse Module

MeSH Terms

ID	Term
D050781	Transcranial Magnetic Stimulation

Ancestor Terms

ID	Term
D055909	Magnetic Field Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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.