Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT06376734
Eligibility Criteria:
Inclusion Criteria:
* Age 18-65
* English proficiency sufficient for informed consent, questionnaires/tasks, and treatment
* Primary diagnosis of one of the following: major depressive disorder (MDD), obsessive-compulsive disorder (OCD), generalized anxiety disorder (GAD), or schizophrenia (determined by focal assessment using the Structured Clinical Interview for DSM-5)
* ≥20 on the Beck Depression Inventory for patients with MDD
* ≥16 on the Beck Anxiety Inventory for patients with GAD
* ≥16 on the Yale-Brown Obsessive-Compulsive Scale for patients with OCD
* ≥58 on the Positive and Negative Symptom Scale for patients with schizophrenia
* Stable psychotropic medication regimen, or remain medication free, for 4 weeks prior to treatment (Medication changes during study enrollment period will be tracked for post hoc analysis).
* Primary clinician (e.g. psychiatrist, therapist, psychologist, APRN, PA, etc.) responsible for psychiatric care before, during, and after the trial
Exclusion Criteria:
* Active pregnancy as determined by a urine pregnancy test
* Cluster B personality disorders (antisocial personality disorder, borderline personality disorder, histrionic personality disorder, narcissistic personality disorder)
* PTSD with active, clinically significant symptoms, as determined by clinician
* Diagnosis of Schizoaffective Disorder, Bipolar Type
* Recent (within 4 weeks) or concurrent use of rapid-acting antidepressant agent (ketamine/esketamine/ECT)
* Ferromagnetic metallic implant that would contraindicate receiving TMS or obtaining MRI
* Any other TMS or MRI safety concerns identified by the clinician
* Receiving or planning to receive other TMS treatments during course of participation
* History of:
* Neurosurgical intervention for mental illness
* Moderate to severe autism spectrum disorder
* Intellectual disability
* Severe cognitive impairment
* Significant neurological illness (e.g., dementia, Parkinson's, Huntington's, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis)
* Untreated or insufficiently treated endocrine disorder
* Eating disorders
* Treatment with investigational drug or intervention during the study period
* Current evidence of:
* Mania or hypomania
* Active suicidal ideation or a suicide attempt within the past year
* Contraindications to either TMS or MRI (e.g., metallic implants, etc.).
* Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal
* Significantly increased seizure risk as determined by a clinician
* For participants with schizophrenia:
* Evidence of impaired capacity to consent, e.g. impaired insight into illness, as deemed by a licensed psychiatrist or psychologist on the study team
* Hospitalization with psychosis in the past 6 months
* Positive urine drug screen for illicit substances
* Existing tinnitus (ringing in the ears)
* Any other condition deemed by the PI to interfere with the study or increase risk to the participant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06376734
Study Brief:
Protocol Section:
NCT06376734