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:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT04239651
Eligibility Criteria:
Inclusion Criteria:
* Age 21-60 years
* Suffering from a major depressive episode based on Diagnostic and Statistical manual (DSM) 5 criteria and having failed two or more standard antidepressant treatments during the current episode.
* Hamilton Depression Rating Scale (17-HAM-D) score of 21 or more
* Participant may be on psychotropic medications including antidepressants, antipsychotics, benzodiazepines and anticonvulsants
* Able and willing to provide informed consent.
Exclusion Criteria:
* Diagnosis with the following conditions (current unless otherwise stated):
* Have a neurological disorder, including a history of seizures, cerebrovascular disease, primary or secondary tumors in central nervous system, stroke, cerebral aneurysm or movement disorder or any lifetime history of loss of consciousness due to head injury.
* Any current Axis 1 psychotic disorder (including substance-induced psychosis, psychotic disorder due to a medical condition, or major depression with psychotic features), as defined by the MINI (Mini International Neuropsychiatric Interview; English Version 7.0.0 for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); Copyright 1992---2014 Sheehan DV) at the screening visit.
* Any lifetime Axis 1 psychotic disorder (excluding substance-induced psychosis, or psychotic disorder due to a medical condition), or as defined by the MINI at the screening visit.
* Any current Axis II personality disorder that would interfere in the participation of the study as determined or might affect cognition and ability to meaningfully participate. In addition to mental retardation identified through medical history or in the opinion of the investigator.
* Have a current amnestic disorder, dementia, or delirium as defined by Montreal Cognitive Assessment of less than or equal to 16 or any other neurological or mental disease that might affect cognition or the ability to meaningfully participate in cognitive behavioral therapy (CBT).
* Any illicit substance use as determined by positive toxicology screen for drugs of abuse; or alcohol and/or substance abuse or dependence within the past 3 months (90 days) as determined by the MINI at the screening visit
* Treatment histories including prior treatment with TMS.
* Have active suicidal intent or plan as defined by a positive answer to questions 4 and/or 5 on the Columbia-Suicide Severity Rating Scale (CSSRS): Screening version; or more than one suicide attempt in lifetime; or a suicide attempt in the past twelve months; or in the Investigator's opinion, is likely to attempt suicide within the next six months.
* Participation in any drug or device clinical trial in the six weeks (42 days) prior to the screening visit and/or participation in another clinical trial for the duration of the study.
* Presence of any other condition or circumstance that, in the opinion of the investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT04239651
Study Brief:
Protocol Section:
NCT04239651