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Neurostimulation

rTMS for Depression (NCP Trial)

N/A

Waitlist Available

Led By Fidel Vila-Rodriguez, M.D., Ph.D.

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of > 3 in the current episode OR have been unable to tolerate at least two separate trials of antidepressants at less than the minimum adequate dose and/or duration (ATHF 1 or 2)

Patients must be between the ages of 18 and 65 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and week 10

Awards & highlights

NCP Trial Summary

This trial is testing whether a treatment that stimulates a specific area of the brain can help people with depression who haven't responded to other treatments.

Who is the study for?

This trial is for adults aged 18-65 with Major Depressive Disorder (MDD) who haven't responded to antidepressants, as shown by a score ≥ 18 on the HDRS-17. Participants must be able to follow the treatment schedule and have not had any psychotropic medication changes in the last four weeks. Exclusions include pregnancy, previous rTMS treatment, certain medications like high-dose lorazepam or anticonvulsants, substance use within three months, major medical illnesses, primary anxiety or personality disorders causing more impairment than MDD, history of seizure or significant neurological issues.Check my eligibility

What is being tested?

The study tests if Repetitive Transcranial Magnetic Stimulation (rTMS) can change brain connectivity related to heart rate regulation in those with depression. It involves stimulating specific brain areas using rTMS while monitoring changes through fMRI before and after a course of iTBS treatments over 30 sessions.See study design

What are the potential side effects?

Potential side effects of rTMS may include discomfort at the stimulation site, headache, lightheadedness, seizures (very rare), hearing loss if ear protection isn't used during treatment. Most side effects are mild and temporary.

NCP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My depression hasn't improved after trying enough of at least one antidepressant, or I couldn't tolerate two different ones.

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I am between 18 and 65 years old.

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I am a patient seeking outpatient treatment.

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I am willing and able to agree to treatment on my own.

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I have been diagnosed with major depression.

NCP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and week 10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and week 10

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline in Depressive Symptoms using HDRS-17 Scale at Week 10

Secondary outcome measures

Change from Baseline in Anxiety Symptoms using HAM-A Scale at Week 10

Change from Baseline in Depressive Symptoms using QIDS-16 Scale at Week 10

NCP Trial Design

1Treatment groups

Experimental Treatment

Group I: Active iTBSExperimental Treatment1 Intervention

Active intermittent theta-burst stimulation (iTBS) rTMS session on the left dorsolateral prefrontal cortex (L-DLPFC)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Repetitive Transcranial Magnetic Stimulation

2013

Completed Phase 3

~1170

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor

1,415 Previous Clinical Trials

2,466,906 Total Patients Enrolled

41 Trials studying Depression

13,228 Patients Enrolled for Depression

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,341 Previous Clinical Trials

26,452,603 Total Patients Enrolled

44 Trials studying Depression

3,273,189 Patients Enrolled for Depression

Fidel Vila-Rodriguez, M.D., Ph.D.Principal InvestigatorDepartment of Psychiatry, UBC

Media Library

Repetitive Transcranial Magnetic Stimulation (Neurostimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05139862 — N/A

Depression Research Study Groups: Active iTBS

Depression Clinical Trial 2023: Repetitive Transcranial Magnetic Stimulation Highlights & Side Effects. Trial Name: NCT05139862 — N/A

Repetitive Transcranial Magnetic Stimulation (Neurostimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05139862 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical investigation permit participation by adults exceeding two decades of age?

"The age range accepted for this research is between 18 and 65."

Answered by AI

Does this research opportunity remain available for potential participants?

"Clinicaltrials.gov data shows that this particular medical trial is no longer recruiting participants, as the last update was issued on January 18th of 2022. Despite this fact, there are 1,297 other trials with open enrollment at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neurocardiac Predictors of Treatment Response to rTMS in Depression

Fidel Vila-Rodriguez 2022. "Neurocardiac Predictors of Treatment Response to rTMS in Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05139862.