This trial is no longer recruiting

Recruitment for this study has ended, so applications are closed. You can still read the trial details, or browse similar trials that are currently recruiting.

Not recruiting

TMS for DepressionAccelerated TMS for Depression and OCD

Sponsor:

Weill Medical College of Cornell University

Code:

NCT04982757

Conditions

Depression

OCD

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

MagVenture MagPro System with Brainsight neuronavigation device

Study Details

Brief 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.

Conditions

Depression

OCD

Study ID

NCT04982757

Start date

Dec 7, 2021

Status verified date

Aug, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

experimental: 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.

active comparator: 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.

Interventions

MagVenture MagPro System with Brainsight neuronavigation device

10x daily sessions of 1200 pulses of theta-burst stimulation lasting approximately ten minutes.

Primary outcome measure

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) ]
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) ]

Central Contacts and Locations

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-14. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-08-20.