Niapsan as Add -on Therapy to Antipsychotic Treatment in First Episode Psychosis
Information source: Nova Scotia Health Authority
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psychosis
Intervention: Niaspan (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Nova Scotia Health Authority Official(s) and/or principal investigator(s): Heather I Milliken, MD, Principal Investigator, Affiliation: Nova Scotia Health Authority
Summary
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.
Clinical Details
Official title: A 1 Year Randomized, Controlled, Open-Label Study of the Impact of Flexible Doses of Niacin (NIASPAN) as an Adjunct to Antipsychotic Medication in the Treatment of First Episode Psychosis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: standardized and experimental measures of attention, memory, and executive function. Measurement tools=MATRICS; DalCAB
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Both.
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
Locations and Contacts
NS Early Psychosis Program, Halifax, Nova Scotia B3H 2E2, Canada
Additional Information
Starting date: October 2009
Last updated: August 6, 2015
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