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 @ 4:36 AM
Ignite Modification Date:
2025-12-25 @ 4:36 AM
NCT ID:
NCT03336918
Eligibility Criteria:
Inclusion criteria for BD subjects:
* ages 18-60 years (inclusive) and able to give voluntary informed consent;
* Satisfy criteria for Diagnostic and Statistical Manual 5th edition (DSM-V) for BD I or II, current Depressive Episode;
* 17-item Hamilton Depression Rating Scale (HAM-D) score \>15 and \<25;
* Young Mania Rating Scale (YMRS) \< 8;
* no psychotropics in the last 2 weeks (if previously on fluoxetine then medication free for 5 weeks) OR on stable psychotropic medications for 12 weeks
* no lithium treatment for past 6 months;
* satisfy criteria to undergo an MRI scan based on MRI screening questionnaire;
* able to be managed as outpatients during the study as ascertained by Clinical Global Severity Scale \< 5 (i.e., moderately ill) and no significant suicidal or homicidal ideation or gross disability.
Exclusion criteria for BD subjects are:
* meeting DSM-IV criteria for schizophrenia, schizoaffective disorder, or an anxiety disorder as
* a primary diagnosis;
* requiring inpatient treatment;
* meeting DSM-V criteria for substance dependence within the past 3 months, except caffeine or nicotine;
* positive urinary toxicology screening at screening visit;
* use of alcohol in the past 1 week;
* serious medical or neurological illness;
* current pregnancy or breast feeding;
* metallic implants or other contraindications to MRI.
Inclusion criteria for healthy subjects:
* ages 18-60 years and ability to give voluntary informed consent;
* no history of psychiatric illness or substance abuse or dependence;
* no significant family history of psychiatric or neurological illness in first degree relative;
* not currently taking any prescription or centrally acting medications;
* no use of alcohol in the past 1 week;
* and no serious medical or neurological illness.
Exclusion criteria for healthy subjects are:
* under 18 years of age;
* pregnant or breast-feeding;
* metallic implants or other contraindication to MRI.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03336918
Study Brief:
Protocol Section:
NCT03336918