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DepressionNCT04982757

Accelerated TMS for Depression and OCD

A study testing MagVenture MagPro System with Brainsight neuronavigation device in people with Depression and OCD, run by Weill Medical College of Cornell University at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Depression, OCD
What is being tested?
MagVenture MagPro System with Brainsight neuronavigation device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteUnited States
Study dates
7 Dec 2021to Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • Weill Cornell Medicine

    New York, New York, 10065

Other trials in United States

About this study

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.

Read more

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
Being tested
MagVenture MagPro System with Brainsight neuronavigation device
Keywords
TMS
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MagVenture MagPro System with Brainsight neuronavigation deviceDevice

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

Study groups in NCT04982757
Study groupRoleWhat they receive
Depression - DMPFC target to (for non-responders) LPFC targetExperimentalParticipants 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.
Receives: Device: MagVenture MagPro System with Brainsight neuronavigation device
Depression - LPFC target to (for non-responders) DMPFC targetActive comparatorParticipants 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.
Receives: Device: MagVenture MagPro System with Brainsight neuronavigation device
OCD - DMPFC target to (for non-responders) LPFC targetExperimentalParticipants 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.
Receives: Device: MagVenture MagPro System with Brainsight neuronavigation device
OCD - LPFC target to (for non-responders) DMPFC targetActive comparatorParticipants 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.
Receives: Device: MagVenture MagPro System with Brainsight neuronavigation device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change in Yale-Brown Obsessive Compulsive Scale (YBOCS) scores for participants with OCD

    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.

    Measured: Baseline to Treatment End: Day 5, 10, 15, or 20 (depending on number of 5-day treatment courses administered)

  2. Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores for participants with treatment resistant depression

    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.

    Measured: Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered)

Secondary outcomes (10)
  1. Percent Change in Quick Inventory of Depressive Symptomatology (QIDS) scores for participants with OCD

    The QIDS is a self-report measure of depression symptoms and is scored on a scale of 0 to 27, with 0 being no depressive symptoms and 27 being severe depressive symptoms.

    Measured: Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered)

  2. Percent Change in Beck Depression Inventory (BDI) scores for participants with OCD

    The BDI is a self-report measure of depression symptoms and is scored on a scale of 0 to 63, with 0 being no depressive symptoms and 63 being severe depressive symptoms.

    Measured: Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered)

  3. Percent Change in Patient Health Questionnaire (PHQ-9) scores for participants with OCD

    The PHQ-9 is a self-report measure of depression symptoms and is scored on a scale of 0 to 63, with 0 being no depressive symptoms and 63 being severe depressive symptoms.

    Measured: Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered)

  4. Percent Change in Patient Health Questionnaire-9 (PHQ-9) scores for participants with OCD

    The PHQ-9 is a self-report measure of depression symptoms and is scored on a scale of 0 to 63, with 0 being no depressive symptoms and 27 being severe depressive symptoms.

    Measured: Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered)

  5. Percent Change in Beck Anxiety Inventory (BAI) scores for participants with OCD

    The BAI is a self-report measure of anxiety symptoms and is scored on a scale of 0 to 63, with 0 being no anxiety symptoms and 63 being severe anxiety symptoms.

    Measured: Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered)

  6. Percent Change in General Anxiety Disorder (GAD-7) scores for participants with OCD

    The BAI is a self-report measure of anxiety symptoms and is scored on a scale of 0 to 21, with 0 being no anxiety symptoms and 21 being severe anxiety symptoms.

    Measured: Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered)

  7. Percent Change in 17-item Hamilton Depression Rating Scale (HAM-D) scores for participants with treatment resistant depression

    The HAM-D is a clinician-rated measure of depression symptoms and is scored on a scale of 0 to 52, with 0 being no anxiety symptoms and 21 being severe depression symptoms.

    Measured: Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered)

  8. Percent Change in Beck Depression Inventory (BDI) scores for participants with treatment resistant depression

    The BDI is a self-report measure of depression symptoms and is scored on a scale of 0 to 63, with 0 being no depressive symptoms and 63 being severe depressive symptoms.

    Measured: Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered)

  9. Change in resting-state fMRI connectivity between the frontostriatal network and limbic network in participants with OCD

    Change in resting state fMRI connectivity between the frontostriatal network and limbic network will be measured as a between-network correlational score of 0 to 1, with 0 low between-network connectivity and 1 being the highest possible between-network connectivity.

    Measured: Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered)

  10. Change in resting-state fMRI connectivity between the frontostriatal network and limbic network in participants with treatment resistant depression

    Change in resting state fMRI connectivity between the frontostriatal network and limbic network will be measured as a between-network correlational score of 0 to 1, with 0 low between-network connectivity and 1 being the highest possible between-network connectivity.

    Measured: Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2021
  2. Study start7 Dec 2021
  3. Primary completionMay 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Subjects will be randomized to receive rTMS targeting the DMPFC or the LPFC. The treatment course will be 10 sessions per day hourly for 5 days. Participants may have the option to be crossed over to receive rTMS targeting the opposite brain area, 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.
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04982757
Sponsor's protocol ID
20-10022827
Other IDs
UG3MH137656
Status last verified
Aug 2026
First submitted
17 Jul 2021
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Individual data collected during the trial will be available after deidentification upon request to the PI. Data to be shared include deidentified clinical assessment scores and MRI images.

Questions about this trial

What is this clinical trial studying?

A study testing MagVenture MagPro System with Brainsight neuronavigation device in people with Depression and OCD, run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.

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