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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT02929667
Eligibility Criteria:
Inclusion Criteria:
1. Adult patients aged 18 or older
2. Patients with epilepsy
3. Native English speaker or adequate fluency in English to provide informed consent.
4. Female patients of child-bearing potential must be using an acceptable method of contraception, and willing to refrain from sexual intercourse during the study.
Exclusion Criteria:
1. Progressive neurological disease.
2. Clinical diagnosis of bipolar disease, panic disorder, psychosis or severe depression, or PHQ-9 score \> 20
3. Patients with prior hospitalization related to depression or Electroconvulsive therapy.
4. History of suicidal ideation or intent in past or present
5. Clinical history or laboratory evidence of hepatic or renal insufficiency.
6. Pregnant or lactating women.
7. Current heavy alcohol use (\>14 drinks per week for men or \>7 drinks per week for women) or) known medical disorder related to alcohol use or current illicit drug use, other than marijuana and its derivatives.
8. Patients with recent use (\<1 month) or already taking fluoxetine or other selective serotonin reuptake inhibitors (SSRIs).
9. Concurrent use of monoamine oxidase inhibitors, antipsychotic agents, antidepressant agents other than SSRIs or frequent use of triptan agents (\>2/week).
10. History of a previous allergic reaction or adverse effects with fluoxetine, hypersensitive reaction-anaphylaxis; laryngeal edema; hives
11. History of serotonin syndrome.
12. History of uncontrolled pulmonary or cardiac illness.
13. Patients with hypercapnic ventilatory response (HCVR) slope of \> 2.0
14. Patients with known prolong QT interval
15. Patients with family history of prolong QT interval
16. Patients with family history of sudden cardiac death under the age of 40 in a first degree relative.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02929667
Study Brief:
Protocol Section:
NCT02929667