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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01720095
Recruitment Status : Completed
First Posted : November 2, 2012
Last Update Posted : August 7, 2015
Information provided by (Responsible Party):
Nova Scotia Health Authority

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.

Condition or disease Intervention/treatment Phase
Psychosis Drug: Niaspan Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2009
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Niacin

Arm Intervention/treatment
Experimental: Niaspan
these are the first episode psychosis patients that are randomized to receive niaspan
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

Primary Outcome Measures :
  1. 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 ]
    Outcomes will be measured by comparison of pre-treatment, post-treatment and twelve month

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:


  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


  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.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01720095

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Canada, Nova Scotia
NS Early Psychosis Program
Halifax, Nova Scotia, Canada, B3H 2E2
Sponsors and Collaborators
Nova Scotia Health Authority
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Principal Investigator: Heather I Milliken, MD Nova Scotia Health Authority
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Responsible Party: Nova Scotia Health Authority Identifier: NCT01720095    
Obsolete Identifiers: NCT01041053
Other Study ID Numbers: CDHA_RS/2010-116
First Posted: November 2, 2012    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: October 2012
Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Nicotinic Acids
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Physiological Effects of Drugs