RECRUITING

Accelerated TMS for Depression and OCD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

COVID-19 Compatible Accelerated TMS Therapy

Quick Facts

Study Start:2021-12-07

Study Completion:2026-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04982757

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Megan Johnson

CONTACT

646-962-2900

tmsinfo@med.cornell.edu

Lindsay Victoria, PhD

CONTACT

liv3002@med.cornell.edu

Principal Investigator

Conor Liston, MD, PhD

PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

Conor Liston, MD, PhD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-07

Study Completion Date2026-08

Study Record Updates

Study Start Date2021-12-07

Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

Additional Relevant MeSH Terms

Depression
OCD