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 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT01793935
Eligibility Criteria:
Inclusion Criteria:
1. Adult males or females (≥ 18 years, to 75 years)
2. DSM IV TR diagnosis of schizophrenia or schizoaffective disorder (If officially instituted by study initiation: DSM V diagnoses will be used).
3. Ability to provide informed written consent
4. PANSS total score ≥ 60, positive symptom cluster, (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility and unusual thought content with at least 2 items scoring ≥ 4, or one of these items scoring ≥ 5, on a scale ranging from 1 = absent to 7 = extreme
5. Current symptom exacerbation ≥ 2 weeks, but ≤ 1 year
6. Receiving anti-psychotic medications for ≥ 4 weeks
7. For women of child bearing age, a negative pregnancy test at screening.
Exclusion Criteria:
1. Testing positive for illicit substances (marijuana or alcohol use will be assessed on a case by case basis, caffeine and nicotine are excepted)
2. Receiving pharmacological treatment for addictions (naltrexone, suboxone, acamprosate, others) will be reviewed on a case by case basis
3. Seriously unstable medical illnesses
4. Pregnant or breast feeding women
5. Known allergy or history of serious adverse event with WSE
6. Subjects who may require imminent hospitalization (examples: suicidal or aggressive behavior)
7. Currently receiving antibiotics, anti-viral, or anti-parasitic medications
8. Currently receiving immunosuppressive medications (e.g. corticosteroids, chemotherapy or transplantation or HIV/AIDs associated drugs).
9. Currently receiving NSAIDs or Aspirin (\>81 mg/day) on a daily basis or PRN use \> 2x/week (in the last 4 weeks).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01793935
Study Brief:
Protocol Section:
NCT01793935