NCT04982757 · Weill Medical College of Cornell University
Accelerated TMS for Depression and OCD
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
MagVenture MagPro System with Brainsight neuronavigation device
10x daily sessions of 1200 pulses of theta-burst stimulation lasting approximately ten minutes.
Primary outcome measures
Percent Change in Yale-Brown Obsessive Compulsive Scale (YBOCS) scores for participants with OCD
Time frame: Baseline to Treatment End: Day 5, 10, 15, or 20 (depending on number of 5-day treatment courses administered)
The YBOCS is a measure of obsessive compulsive symptoms is scored on a scale of 0 to 40, with 0 being no symptoms and 40 being extreme symptoms of OCD.
Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores for participants with treatment resistant depression
Time frame: Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered)
The MADRS is a measure of depression symptoms and is scored on a scale of 0 to 60, with 0 being no depressive symptoms and 60 being severe depressive symptoms.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnosis of major depressive disorder OR obsessive-compulsive disorder (DSM-V 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
- 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 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
Where
- New York, New York
Collaborators
The New Venture Fund / Foundation for OCD Research, The Wellcome Leap Fund, National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations