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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT02804334
Eligibility Criteria:
Inclusion Criteria for Healthy Volunteers (Group 1)
For inclusion in this study, subjects must meet all of the following criteria:
1. Able to provide informed consent;
2. Male or female, at least 18 years of age;
3. Physically healthy
4. No current and/or lifetime psychiatric disorder assessed with the MINI for Diagnostic and Statistical Manual-5 (DSM-5);
5. Willing to have blood draw.
Exclusion Criteria for Healthy Volunteers (Group 1)
Any of the following is regarded as a criterion for exclusion from the study:
1. Unwilling to comply with study requirements;
2. Unwilling to have blood draw;
3. Patients with chronic medical conditions such as diabetes, cardiovascular disease, immune diseases, infectious diseases and neurological disorders;
4. Tests positive for illegal substances or prescriptions medications for which participants do not have a valid prescription;
5. Currently pregnant.
6. A lifetime history of a psychiatric disorder
Inclusion Criteria for Untreated Bipolar Subjects (Group 2)
For inclusion in this study, subjects must meet all of the following criteria:
1. Able to provide informed consent;
2. Male or female, at least 18 years of age;
3. Meets current DSM-5 criteria for bipolar type I (BPI) or bipolar type II (BP II) disorder as assessed by the MINI.
4. Depression severity should be measured with Montgomery-Asberg Depression Rating Scale (MADRS). A MADRS total score ≥ 20 is required at Screening Visit/Baseline Evaluation.
5. Has experienced impairment as documented by a score consistent with moderate impairment (4 or more on at least one of the three subscales of the Sheehan Disability Scale (SDS), which includes an assessment of work-life, family-life, and social life (no/mild impairment 0-3, moderate impairment 4-6, severe impairment 7-10)
6. Have not taken any psychotropic medications within the past 4 weeks;
7. Willing to have blood draw.
Exclusion Criteria for Untreated Bipolar Subjects (Group 2)
Any of the following is regarded as a criterion for exclusion from the study:
1. Unwilling to comply with study requirements;
2. Unwilling to have blood draw;
3. Patients with chronic medical conditions such as diabetes, cardiovascular disease, immune diseases, infectious diseases, and neurological disorders;
4. Tests positive for illegal substances or prescriptions medications for which participants do not have a valid prescription;
5. Currently pregnant.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02804334
Study Brief:
Protocol Section:
NCT02804334