Niapsan as Add -on Therapy to Antipsychotic Treatment in First Episode Psychosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Capital District Health Authority, Canada
Sponsor:
Information provided by (Responsible Party):
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01720095
First received: October 24, 2012
Last updated: October 31, 2012
Last verified: October 2012

October 24, 2012
October 31, 2012
October 2009
December 2014   (final data collection date for primary outcome measure)
standardized and experimental measures of attention, memory, and executive function. Measurement tools=MATRICS; DalCAB [ Time Frame: change in cognitive function from baseline to 3, 6, and 12 months ] [ Designated as safety issue: No ]
Outcomes will be measured by comparison of pre-treatment, post-treatment and twelve month
Same as current
Complete list of historical versions of study NCT01720095 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Niapsan as Add -on Therapy to Antipsychotic Treatment in First Episode Psychosis
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

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Psychosis
Drug: Niaspan
  • Experimental: Niaspan
    these are the first episode psychosis patients that are randomized to receive niaspan
    Intervention: Drug: Niaspan
  • No Intervention: healthy control
    this is the group of healthy controls for cognitive outcome measures
  • No Intervention: first episode control group
    first episode psychosis patients who are randomized to no intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
Not Provided
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 35 Years
Yes
Contact: Heather I Milliken, MD 902-473-2976
Canada
 
NCT01720095
CDHA_RS/2010-116
No
Capital District Health Authority, Canada
Capital District Health Authority, Canada
Not Provided
Principal Investigator: Heather I Milliken, MD Capital District Health Authority, Canada
Capital District Health Authority, Canada
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP