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 @ 1:47 PM
Ignite Modification Date:
2025-12-24 @ 1:47 PM
NCT ID:
NCT01720095
Eligibility Criteria:
Inclusion Criteria:
ALL SUBJECTS
1. Must understand the nature of the study, must provide written informed consent prior to the conduct of any study procedures/assessments and are willing/able to participate in study procedures/assessments as specified in this protocol.
2. Must be between the ages of 18 - 35
PATIENTS
1. Within one year of initial DSM 1V TR diagnosis of schizophreniform psychosis, schizophrenia, schizoaffective disorder or psychotic disorder NOS
2. Outpatients
3. Females of child bearing potential who have a negative serum pregnancy test prior to enrolment and agree to use a reliable method of birth control (use of oral contraceptives or Norplant; contraceptive injections; contraceptive patch; double barrier method; intrauterine devices; partner with vasectomy or abstinence) during the study and for one month following the last dose of study drug.
HEALTHY CONTROLS
1\. Age-matched to experimental groups
Exclusion Criteria:
1. Due to their underlying mental disorder are considered by the investigator(s) to be unable to provide informed consent and/or unwilling or unable to participate in study procedures/assessments
2. Are judged by the investigator(s) (based on history, mental status examination or clinical impression) as being at significant risk of self-injurious/suicidal or violent/homicidal behaviour
3. Meet criteria for substance abuse or dependence (excluding nicotine and caffeine) as defined by DSM IV-TR at the time of screening and/or within the preceding 6 months
4. Have unstable medical, psychiatric, neurological or behavioural disorders that may interfere in the conduct or interpretation of the study.
5. Have a history of pre-existing liver dysfunction and/or at screening have abnormal liver function tests (ALT\>2x upper limit of normal; AST\>3x upper limit of normal; Bilirubin\>1.5x upper limit of normal)
6. Have a past or current history of peptic ulcer, gout or bleeding problems
7. Have a past or current history of hypophosphatemia
8. Have a history of head injury resulting in loss of consciousness of \> 5 minutes or other neurological disorder (e.g., seizures, stroke, MS)
9. Are currently taking a vitamin or nutritional supplement containing a dose of niacin/nicotinic acid above 100 mg/day.
10. Are currently receiving treatment with any of the following medications:
1. Anticoagulants
2. Statins
3. Antihypertensives
11. Are currently receiving treatment for Type 1 or Type 2 diabetes
12. Have a history of allergic reactions to NIASPAN or any of its non-medicinal ingredients (methylcellulose, povidone, stearic acid), niacin or nicotinic acid
13. Are currently participating in any other investigational drug study
14. Are a professional or staff member affiliated with the Nova Scotia Early Psychosis Program or are an immediate family member defined as spouse, parent, child, sibling, grandparent or grandchild
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT01720095
Study Brief:
Protocol Section:
NCT01720095