Clinical trial NCT01720095: Niapsan as Add -on Therapy to Antipsychotic Treatment in First Episode Psychosis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psychosis
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2012-11-02
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: standardized and experimental measures of attention, memory, and executive function. Measurement tools=MATRICS; DalCAB
timeFrame: change in cognitive function from baseline to 3, 6, and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: NS Early Psychosis Program
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Heather I Milliken, MD
role: PRINCIPAL_INVESTIGATOR
References: