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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT04284267
Eligibility Criteria:
Inclusion Criteria (Healthy Controls)
1. Male or female age 18-55
2. No history of psychiatric disorder, as assessed using the Mini-International Neuropsychiatric Interview (MINI).
3. Non-Clinical Levels of Emotion Dysregulation, as assessed using the Difficulties in Emotion Regulation Scale (DERS) Non-clinical levels of emotion dysregulation will be defined as a score \< 80 on the DERS.
Exclusion Criteria (Healthy Controls)
1. Current or history of psychiatric disorders
2. Endorsement of clinical levels of emotion dysregulation
3. Current or history of: organic mental disorder; substance abuse within the past 12 months and/or history of substance abuse for \> 1 year; past or current substance dependence (including alcohol); schizophrenia; delusional disorder; and psychotic disorders.
4. Current pregnancy.
5. Medical illness or non-psychiatric medical treatment that would likely interfere with study participation
6. Neurologic disorder, prior neurosurgical procedure, prior electroconvulsive therapy (ECT) or TMS, history of seizures or head trauma.
7. Presence of metallic implants that would interfere with safety during fMRI scanning.
Inclusion Criteria (Bipolar Disorder Group)
1. Male or female age 18-55
2. Diagnosis of Bipolar I Disorder (BD-I), as assessed through MINI.
3. Current mood state euthymic.
a. Hamilton-Depression Rating Scale (HAM-D-17) and Young Mania Rating Scale (YMRS) will be used to assess current depressive and manic symptoms. Euthymia will be defined as a HAM-D-17 score \<10 and YMRS score \<12.
4. Clinical Levels of Emotion Dysregulation, as assessed using the DERS. Clinical levels of emotion dysregulation will be defined as a score \> 80 on the DERS.
Exclusion Criteria (Bipolar Disorder Group)
1. Current symptoms of mania or depression (YMRS score \>12, HAM-D-17 score \>10).
2. Medication instability (\<3 months).
3. Current or history of: organic mental disorder; substance abuse within the past 12 months and/or history of substance abuse for \> 1 year; past or current substance dependence (including alcohol), verified by urine toxicology screen; schizophrenia; delusional disorder; and psychotic disorders.
4. Current pregnancy.
5. Medical illness or non-psychiatric medical treatment that would likely interfere with study participation
6. Neurologic disorder, prior neurosurgical procedure, prior ECT or TMS, history of seizures or head trauma.
7. Presence of metallic implants that would interfere with safety during fMRI scanning.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
55 Years
Study:
NCT04284267
Study Brief:
Protocol Section:
NCT04284267