Study Summary
This trial is testing whether using brain network connectivity patterns can help optimize outcomes from rTMS treatment for depression.
Eligible Conditions
- Depression
- Major Depressive Disorder
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: Baseline and 1 Week Post Treatment (8-10 weeks)
Week 10
Change in depression, as measured by the Hamilton Depression Rating Scale (HAMD17)
Week 9
Change in depression, as measured by the Beck Depression Inventory (BDI-21)
Change in depression, as measured by the Quick Inventory of Depressive Symptomology (QIDS)
Week 9
Change in Resting State fMRI Connectivity
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
rTMS With Sensorimotor Retraining, Then rTMS With CTL
40%Decreased balance
20%Abnormal Sleep Pattern
20%Mood change
Trial Design
3 Treatment Groups
Opposite Side Arm
1 of 3
Standard of Care
1 of 3
Targeted Side Arm
1 of 3
Active Control
Experimental Treatment
348 Total Participants · 3 Treatment Groups
Primary Treatment: Repetitive Transcranial Magnetic Stimulation · No Placebo Group · Phase 3
Targeted Side Arm
Device
Experimental Group · 1 Intervention: Repetitive Transcranial Magnetic Stimulation · Intervention Types: DeviceOpposite Side Arm
Device
ActiveComparator Group · 1 Intervention: Repetitive Transcranial Magnetic Stimulation · Intervention Types: DeviceStandard of Care
Device
ActiveComparator Group · 1 Intervention: Repetitive Transcranial Magnetic Stimulation · Intervention Types: DeviceTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Repetitive Transcranial Magnetic Stimulation
2013
Completed Phase 3
~1130
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and 1 week post treatment (8-10 weeks)
Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,555 Previous Clinical Trials
1,823,411 Total Patients Enrolled
611 Trials studying Depression
242,386 Patients Enrolled for Depression
Weill Medical College of Cornell UniversityLead Sponsor
989 Previous Clinical Trials
1,338,582 Total Patients Enrolled
60 Trials studying Depression
15,484 Patients Enrolled for Depression
Conor Liston, MD, PhDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
300 Total Patients Enrolled
1 Trials studying Depression
300 Patients Enrolled for Depression
Eligibility Criteria
Age 22 - 65 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are taking a medication intended to treat depression or reduce symptoms of depression.
You have not responded to 1 antidepressant medication at an adequate dose and duration as measured by a modified Antidepressant Treatment History Form.
You have provided written consent to allow communication between members of the research team and the patient's outpatient clinician(s) (psychiatrist, psychotherapist, nurse practitioner, primary care physician, or equivalent) as needed to ensure safety.
Who else is applying?
What state do they live in?
| New York | 70.0% |
| New Jersey | 20.0% |
| Wisconsin | 10.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Weill Cornell Medicine | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 90.0% |
| Did not meet criteria | 10.0% |
How responsive is this trial?
Most responsive sites:
- Weill Cornell Medicine: < 24 hours
Typically responds via
| Phone Call | 25.0% |
| 75.0% | |
Average response time
- < 2 Days
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