Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to help understand if by adding Niaspan FCT (study drug) to antipsychotic medications will it help maintain or improve cognitve functioning.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Niaspan | Experimental | these are the first episode psychosis patients that are randomized to receive niaspan |
|
| healthy control | No Intervention | this is the group of healthy controls for cognitive outcome measures | |
| first episode control group | No Intervention | first episode psychosis patients who are randomized to no intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niaspan | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| standardized and experimental measures of attention, memory, and executive function. Measurement tools=MATRICS; DalCAB | Outcomes will be measured by comparison of pre-treatment, post-treatment and twelve month | change in cognitive function from baseline to 3, 6, and 12 months |
Not provided
Not provided
Inclusion Criteria:
ALL SUBJECTS
PATIENTS
HEALTHY CONTROLS
1. Age-matched to experimental groups
Exclusion Criteria:
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
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
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
Have unstable medical, psychiatric, neurological or behavioural disorders that may interfere in the conduct or interpretation of the study.
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)
Have a past or current history of peptic ulcer, gout or bleeding problems
Have a past or current history of hypophosphatemia
Have a history of head injury resulting in loss of consciousness of > 5 minutes or other neurological disorder (e.g., seizures, stroke, MS)
Are currently taking a vitamin or nutritional supplement containing a dose of niacin/nicotinic acid above 100 mg/day.
Are currently receiving treatment with any of the following medications:
Are currently receiving treatment for Type 1 or Type 2 diabetes
Have a history of allergic reactions to NIASPAN or any of its non-medicinal ingredients (methylcellulose, povidone, stearic acid), niacin or nicotinic acid
Are currently participating in any other investigational drug study
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Heather I Milliken, MD | Nova Scotia Health Authority | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NS Early Psychosis Program | Halifax | Nova Scotia | B3H 2E2 | Canada |
Not provided
| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D009525 | Niacin |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D006573 |
| Heterocyclic Compounds, 1-Ring |