Accelerated TMS for Depression and OCD

Last updated: March 17, 2025
Sponsor: Weill Medical College of Cornell University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Obsessive-compulsive Disorder

Treatment

MagVenture MagPro System with Brainsight neuronavigation device

Clinical Study ID

NCT04982757
20-10022827
UG3MH137656
  • Ages 18-75
  • All Genders

Study Summary

Repetitive transcranial magnetic stimulation (rTMS) is a FDA-approved treatment for depression and Obsessive Compulsive Disorder (OCD). The goal of the study is to learn how to optimize the treatment to improve symptoms of depression and OCD. This research project will test a new accelerated 5-day accelerated rTMS protocol for treating symptoms of depression and OCD.

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of major depressive disorder OR obsessive-compulsive disorder (DSM-Vcriteria)

  • Hamilton Depression Rating Scale score greater than or equal to 18 OR Yale-BrownObsessive-Compulsive Scale score greater than or equal to 16

  • Failed at least 1 prior trial of standard first-line treatment for depression or OCDper the modified Antidepressant Treatment History form and APA Practice Guidelines (e.g. serotonin reuptake inhibitor [SRI] or cognitive behavioral therapy withexposure and response prevention) OR had refused these treatments for individualreasons (e.g., cannot tolerate side effects, cannot tolerate exposure therapy,etc.).

  • Off antidepressants OR on a stable dose of antidepressants for greater than or equalto 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 aninhibitory effect on brain excitability (e.g., anticonvulsants, benzodiazepines, andatypical antipsychotics), or any other medications with relative hazard for use inTMS will be allowed upon review of medications and/or motor threshold determinationby TMS specialist.

  • Capacity to consent

Exclusion

Exclusion Criteria:

  • Imminent risk of suicide (based on the CSSRS)

  • 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 forhis/her age and education)

  • Evidence of psychotic symptoms on diagnostic interview (interfering with capacity toconsent)

  • Have met criteria for any significant substance use disorder within the past 6months

  • Recent onset (within 8 weeks of screening) of psychotherapy

  • Prior completion of this accelerated TMS treatment protocol during the currentdepressive episode

  • Participated in any clinical trial with an investigational drug or device within thepast 6 weeks prior to screening

  • Evidence or history of significant neurological disorder including moderate-severehead trauma, stroke, Parkinson's disease or other movement disorder (except benignessential tremor), epilepsy

  • History of seizures (except juvenile febrile seizures) or any condition/concurrentmedication that could notably lower seizure threshold

  • Presence of foreign metal bodies/implanted intracranial devices (MRIcontraindication)

  • Current pregnancy or planning to conceive during the study

  • Abnormal bloodwork for electrolytes, thyroid or liver function

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: MagVenture MagPro System with Brainsight neuronavigation device
Phase:
Study Start date:
December 07, 2021
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • Weill Cornell Medicine

    New York, New York 10065
    United States

    Active - Recruiting

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