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
  Purpose

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 Intervention Phase
Psychosis
Drug: Niaspan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 45
Study Start Date: October 2009
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720095

Contacts
Contact: Heather I Milliken, MD 902-473-2976

Locations
Canada, Nova Scotia
NS Early Psychosis Program Recruiting
Halifax, Nova Scotia, Canada, B3H 2E2
Contact: Heather I Milliken, MD    902-473-2976      
Principal Investigator: Heather I Milliken, MD         
NS Early Psychosis Program Recruiting
Halifax, Nova Scotia, Canada, B3H 2E2
Contact: Heather I Milliken, MD    902-473-2976      
Sponsors and Collaborators
Capital District Health Authority, Canada
Investigators
Principal Investigator: Heather I Milliken, MD Capital District Health Authority, Canada
  More Information

No publications provided

Responsible Party: Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01720095     History of Changes
Obsolete Identifiers: NCT01041053
Other Study ID Numbers: CDHA_RS/2010-116
Study First Received: October 24, 2012
Last Updated: October 31, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Niacin
Nicotinic Acids
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Vasodilator Agents
Cardiovascular Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 01, 2014