Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2021-12-07
2026-08-31
Brief Summary
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A second goal of this study is to identify biomarkers of depression and OCD in the brain using functional magnetic resonance imaging (fMRI). This approach will predict who will benefit from TMS, determine the optimal treatment target, and improve treatment outcomes. Subjects will receive a clinical assessment of symptoms and an fMRI brain scan before and after each treatment course to measure the effect of treatment on symptom severity and on fMRI measures of functional connectivity.
Participants will be randomized to receive rTMS targeting either the lateral prefrontal cortex (LPFC) or the dorsomedial prefrontal cortex (DMPFC). Participants will complete a 5-day course of rTMS delivered hourly for 10 hours per day. Participants who show a partial response to treatment but not a full response will then receive a second 5-day course. Treatment non-responders will be crossed over to receive rTMS targeting the opposite brain area.
The primary hypothesis is that accelerated rTMS treatment will yield rapid improvement in symptoms for patients with depression and OCD in just 5 days, and that response rates can be further improved by adding a second 5-day treatment course.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Depression - DMPFC target to (for non-responders) LPFC target
Participants with treatment resistant depression will receive a 5-day course of rTMS delivered to the DMPFC. Participants may have the option to be crossed over to receive rTMS targeting the opposite brain area (LPFC), enabling us to test whether participants who do not respond well to one target might respond to stimulation of another target. The option to offer a second course of treatment will be based on clinical judgement and re-evaluation of the participant.
MagVenture MagPro System with Brainsight neuronavigation device
10x daily sessions of 1200 pulses of theta-burst stimulation lasting approximately ten minutes.
Depression - LPFC target to (for non-responders) DMPFC target
Participants with treatment resistant depression will receive a 5-day course of rTMS delivered to the LPFC. Participants may have the option to be crossed over to receive rTMS targeting the opposite brain area (DMPFC), enabling us to test whether participants who do not respond well to one target might respond to stimulation of another target. The option to offer a second course of treatment will be based on clinical judgement and re-evaluation of the participant.
MagVenture MagPro System with Brainsight neuronavigation device
10x daily sessions of 1200 pulses of theta-burst stimulation lasting approximately ten minutes.
OCD - DMPFC target to (for non-responders) LPFC target
Participants with OCD will receive a 5-day course of rTMS delivered to the DMPFC.Participants may have the option to be crossed over to receive rTMS targeting the opposite brain area (LPFC), enabling us to test whether participants who do not respond well to one target might respond to stimulation of another target. The option to offer a second course of treatment will be based on clinical judgement and re-evaluation of the participant.
MagVenture MagPro System with Brainsight neuronavigation device
10x daily sessions of 1200 pulses of theta-burst stimulation lasting approximately ten minutes.
OCD - LPFC target to (for non-responders) DMPFC target
Participants with OCD will receive a 5-day course of rTMS delivered to the LPFC. Participants may have the option to be crossed over to receive rTMS targeting the opposite brain area (DMPFC), enabling us to test whether participants who do not respond well to one target might respond to stimulation of another target. The option to offer a second course of treatment will be based on clinical judgement and re-evaluation of the participant.
MagVenture MagPro System with Brainsight neuronavigation device
10x daily sessions of 1200 pulses of theta-burst stimulation lasting approximately ten minutes.
Interventions
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MagVenture MagPro System with Brainsight neuronavigation device
10x daily sessions of 1200 pulses of theta-burst stimulation lasting approximately ten minutes.
Eligibility Criteria
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Inclusion Criteria
* Hamilton Depression Rating Scale score greater than or equal to 18 OR Yale-Brown Obsessive-Compulsive Scale score greater than or equal to 16
* Failed at least 1 prior trial of standard first-line treatment for depression or OCD per the modified Antidepressant Treatment History form and APA Practice Guidelines (e.g. serotonin reuptake inhibitor \[SRI\] or cognitive behavioral therapy with exposure and response prevention) OR had refused these treatments for individual reasons (e.g., cannot tolerate side effects, cannot tolerate exposure therapy, etc.).
* Off antidepressants OR on a stable dose of antidepressants for greater than or equal to four weeks with plans to remain on this stable dose during the study Note: Medications that are known to increase cortical excitability (e.g., buprorion, maprotiline, tricyclic antidepressants, classical antipsychotics) or to have an inhibitory effect on brain excitability (e.g., anticonvulsants, benzodiazepines, and atypical antipsychotics), or any other medications with relative hazard for use in TMS will be allowed upon review of medications and/or motor threshold determination by TMS specialist.
* Capacity to consent
Exclusion Criteria
* Presence of primary psychiatric diagnoses other than OCD, MDD and/or co-morbid GAD (ex. PTSD, MDD with psychotic features, primary psychotic illness, Bipolar I or II)
* Evidence of cognitive impairment (MMSE score falling 1 SD below mean score for his/her age and education)
* Evidence of psychotic symptoms on diagnostic interview (interfering with capacity to consent)
* Have met criteria for any significant substance use disorder within the past 6 months
* Recent onset (within 8 weeks of screening) of psychotherapy
* Prior completion of this accelerated TMS treatment protocol during the current depressive episode
* Participated in any clinical trial with an investigational drug or device within the past 6 weeks prior to screening
* Evidence or history of significant neurological disorder including moderate-severe head trauma, stroke, Parkinson's disease or other movement disorder (except benign essential tremor), epilepsy
* History of seizures (except juvenile febrile seizures) or any condition/concurrent medication that could notably lower seizure threshold
* Presence of foreign metal bodies/implanted intracranial devices (MRI contraindication)
* Current pregnancy or planning to conceive during the study
* Abnormal bloodwork for electrolytes, thyroid or liver function
18 Years
75 Years
ALL
No
Sponsors
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The New Venture Fund / Foundation for OCD Research
UNKNOWN
The Wellcome Leap Fund
UNKNOWN
National Institute of Mental Health (NIMH)
NIH
Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Conor Liston, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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Weill Cornell Medicine
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20-10022827
Identifier Type: -
Identifier Source: org_study_id
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