ACTIVE_NOT_RECRUITING

Testing a Transdiagnostic TMS Treatment Target

Conditions

Major Depressive Disorder Depression Psychiatric Disorder Mood Disorders Mental Disorder Anxiety Disorders OCD PTSD

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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

The goal of this clinical trial is to test a new brain stimulation treatment target for individuals with depression plus at least one additional psychiatric disorder. The main question is to understand the safety profile of a non-invasive form of brain stimulation called accelerated intermittent theta burst stimulation when it is targeting the posterior parietal cortex. Additional questions focus on whether this stimulation improves symptoms of depression and other psychiatric disorders as well as whether this stimulation changes brain function.

Official Title

Testing a Transdiagnostic TMS Treatment Target

Quick Facts

Study Start:2024-09-09

Study Completion:2026-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06282146

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 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age 18-65 * English proficiency sufficient for informed consent, questionnaires/tasks, and treatment * Diagnosis of MDD per DSM-5 criteria (Quick Structured Clinical Interview for DSM-5 Disorders) and currently experiencing a moderate to severe episode: * \>20 on Beck Depression Inventory (BDI) * \>20 on the Montgomery-Åsberg Depression Rating Scale (MADRS) 14, 15 * Moderate to severe level of treatment resistance (Maudsley Staging Method)16, 17 * Diagnosis of at least one or more of the following psychiatric conditions per DSM-5 criteria (Quick Structured Clinical Interview for DSM-5 Disorders): * Generalized anxiety disorder (GAD), panic disorder (PD), or social anxiety disorder (SAD) * Obsessive compulsive disorder (OCD) * Post-traumatic stress disorder (PTSD) * Physician referral for individuals with either schizophrenia or schizoaffective disorder * Stable psychiatric medication regimen, or remain medication free, for 4 weeks prior to treatment and to remain on this regimen throughout the study until the two-week post-treatment visit * Primary clinician (e.g. psychiatrist, therapist, psychologist, APRN, PA, etc.) responsible for psychiatric care before, during, and after the trial * Agreement to lifestyle considerations * Abstain from becoming pregnant from time of screening to two weeks after treatment (post-treatment MRI visit) * Continue usual intake patterns of caffeine- or xanthine-containing products (e.g. coffee, tea, soft drinks, chocolate) throughout treatment * Abstain from alcohol, tobacco, and recreational drugs for at least 24 hours before the start of each MRI and each TMS session	* Active pregnancy as determined by a urine pregnancy test * Positive urine drug screen for illicit substances (not including THC) * Depressive symptoms refractory to 8 sessions of electroconvulsive therapy (ECT) * Recent (within 4 weeks) or concurrent use of rapid acting antidepressant agent (ketamine/esketamine/ECT) * Receiving or planning to receive other TMS treatments during course of participation * History of * Autism spectrum disorder * Neurosurgical intervention for depression * Intellectual disability * Severe cognitive impairment * Significant neurological illness (e.g., dementia, Parkinson's, Huntington's, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, brain lesion) * Untreated or insufficiently treated endocrine disorder * Treatment with investigational drug or intervention during the study period * Depth-adjusted TMS treatment dose \> 65% maximum stimulator output * Existing tinnitus (ringing in the ears) * Current evidence of: * Mania or hypomania * Active suicidal ideation or a suicide attempt (defined by C-SSRS) within the past year * Neurological lesion * Contraindications to either TMS or MRI (e.g., metallic implants, severe insomnia \> 4 hours per night with hypnotic, etc.). * Moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal (not including cannabis or nicotine use disorders) * Bipolar I disorder * For participants with schizophrenia or schizoaffective disorder referred by a physician: * Total PANSS score \>90 * Score \>4 (moderate-severe) on any positive PANSS item * Active substance use disorder (other than nicotine) * Hospitalization for psychosis in the past 6 months * Severe borderline personality disorder * Any other condition deemed by the PI to interfere with the study or increase risk to the participant

Inclusion Criteria

Exclusion Criteria

* Age 18-65
* English proficiency sufficient for informed consent, questionnaires/tasks, and treatment
* Diagnosis of MDD per DSM-5 criteria (Quick Structured Clinical Interview for DSM-5 Disorders) and currently experiencing a moderate to severe episode:
* \>20 on Beck Depression Inventory (BDI)
* \>20 on the Montgomery-Åsberg Depression Rating Scale (MADRS) 14, 15
* Moderate to severe level of treatment resistance (Maudsley Staging Method)16, 17
* Diagnosis of at least one or more of the following psychiatric conditions per DSM-5 criteria (Quick Structured Clinical Interview for DSM-5 Disorders):
* Generalized anxiety disorder (GAD), panic disorder (PD), or social anxiety disorder (SAD)
* Obsessive compulsive disorder (OCD)
* Post-traumatic stress disorder (PTSD)
* Physician referral for individuals with either schizophrenia or schizoaffective disorder
* Stable psychiatric medication regimen, or remain medication free, for 4 weeks prior to treatment and to remain on this regimen throughout the study until the two-week post-treatment visit
* Primary clinician (e.g. psychiatrist, therapist, psychologist, APRN, PA, etc.) responsible for psychiatric care before, during, and after the trial
* Agreement to lifestyle considerations
* Abstain from becoming pregnant from time of screening to two weeks after treatment (post-treatment MRI visit)
* Continue usual intake patterns of caffeine- or xanthine-containing products (e.g. coffee, tea, soft drinks, chocolate) throughout treatment
* Abstain from alcohol, tobacco, and recreational drugs for at least 24 hours before the start of each MRI and each TMS session

* Active pregnancy as determined by a urine pregnancy test
* Positive urine drug screen for illicit substances (not including THC)
* Depressive symptoms refractory to 8 sessions of electroconvulsive therapy (ECT)
* Recent (within 4 weeks) or concurrent use of rapid acting antidepressant agent (ketamine/esketamine/ECT)
* Receiving or planning to receive other TMS treatments during course of participation
* History of
* Autism spectrum disorder
* Neurosurgical intervention for depression
* Intellectual disability
* Severe cognitive impairment
* Significant neurological illness (e.g., dementia, Parkinson's, Huntington's, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, brain lesion)
* Untreated or insufficiently treated endocrine disorder
* Treatment with investigational drug or intervention during the study period
* Depth-adjusted TMS treatment dose \> 65% maximum stimulator output
* Existing tinnitus (ringing in the ears)
* Current evidence of:
* Mania or hypomania
* Active suicidal ideation or a suicide attempt (defined by C-SSRS) within the past year
* Neurological lesion
* Contraindications to either TMS or MRI (e.g., metallic implants, severe insomnia \> 4 hours per night with hypnotic, etc.).
* Moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal (not including cannabis or nicotine use disorders)
* Bipolar I disorder
* For participants with schizophrenia or schizoaffective disorder referred by a physician:
* Total PANSS score \>90
* Score \>4 (moderate-severe) on any positive PANSS item
* Active substance use disorder (other than nicotine)
* Hospitalization for psychosis in the past 6 months
* Severe borderline personality disorder
* Any other condition deemed by the PI to interfere with the study or increase risk to the participant

Contacts and Locations

Principal Investigator

Joseph J Taylor, MD, PhD

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Joseph J Taylor, MD, PhD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

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 Date2024-09-09

Study Completion Date2026-05-01

Study Record Updates

Study Start Date2024-09-09

Study Completion Date2026-05-01

Terms related to this study

Additional Relevant MeSH Terms

Major Depressive Disorder
Depression
Psychiatric Disorder
Mood Disorders
Mental Disorder
Anxiety Disorders
OCD
PTSD