<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01720095</url>
  </required_header>
  <id_info>
    <org_study_id>CDHA_RS/2010-116</org_study_id>
    <nct_id>NCT01720095</nct_id>
    <nct_alias>NCT01041053</nct_alias>
  </id_info>
  <brief_title>Niapsan as Add -on Therapy to Antipsychotic Treatment in First Episode Psychosis</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nova Scotia Health Authority</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nova Scotia Health Authority</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to help understand if by adding Niaspan FCT (study drug) to&#xD;
      antipsychotic medications will it help maintain or improve cognitve functioning.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2009</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>standardized and experimental measures of attention, memory, and executive function. Measurement tools=MATRICS; DalCAB</measure>
    <time_frame>change in cognitive function from baseline to 3, 6, and 12 months</time_frame>
    <description>Outcomes will be measured by comparison of pre-treatment, post-treatment and twelve month</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Psychosis</condition>
  <arm_group>
    <arm_group_label>Niaspan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>these are the first episode psychosis patients that are randomized to receive niaspan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>this is the group of healthy controls for cognitive outcome measures</description>
  </arm_group>
  <arm_group>
    <arm_group_label>first episode control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>first episode psychosis patients who are randomized to no intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Niaspan</intervention_name>
    <arm_group_label>Niaspan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        ALL SUBJECTS&#xD;
&#xD;
          1. Must understand the nature of the study, must provide written informed consent prior&#xD;
             to the conduct of any study procedures/assessments and are willing/able to participate&#xD;
             in study procedures/assessments as specified in this protocol.&#xD;
&#xD;
          2. Must be between the ages of 18 - 35&#xD;
&#xD;
        PATIENTS&#xD;
&#xD;
          1. Within one year of initial DSM 1V TR diagnosis of schizophreniform psychosis,&#xD;
             schizophrenia, schizoaffective disorder or psychotic disorder NOS&#xD;
&#xD;
          2. Outpatients&#xD;
&#xD;
          3. Females of child bearing potential who have a negative serum pregnancy test prior to&#xD;
             enrolment and agree to use a reliable method of birth control (use of oral&#xD;
             contraceptives or Norplant; contraceptive injections; contraceptive patch; double&#xD;
             barrier method; intrauterine devices; partner with vasectomy or abstinence) during the&#xD;
             study and for one month following the last dose of study drug.&#xD;
&#xD;
        HEALTHY CONTROLS&#xD;
&#xD;
        1. Age-matched to experimental groups&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Due to their underlying mental disorder are considered by the investigator(s) to be&#xD;
             unable to provide informed consent and/or unwilling or unable to participate in study&#xD;
             procedures/assessments&#xD;
&#xD;
          2. Are judged by the investigator(s) (based on history, mental status examination or&#xD;
             clinical impression) as being at significant risk of self-injurious/suicidal or&#xD;
             violent/homicidal behaviour&#xD;
&#xD;
          3. Meet criteria for substance abuse or dependence (excluding nicotine and caffeine) as&#xD;
             defined by DSM IV-TR at the time of screening and/or within the preceding 6 months&#xD;
&#xD;
          4. Have unstable medical, psychiatric, neurological or behavioural disorders that may&#xD;
             interfere in the conduct or interpretation of the study.&#xD;
&#xD;
          5. Have a history of pre-existing liver dysfunction and/or at screening have abnormal&#xD;
             liver function tests (ALT&gt;2x upper limit of normal; AST&gt;3x upper limit of normal;&#xD;
             Bilirubin&gt;1.5x upper limit of normal)&#xD;
&#xD;
          6. Have a past or current history of peptic ulcer, gout or bleeding problems&#xD;
&#xD;
          7. Have a past or current history of hypophosphatemia&#xD;
&#xD;
          8. Have a history of head injury resulting in loss of consciousness of &gt; 5 minutes or&#xD;
             other neurological disorder (e.g., seizures, stroke, MS)&#xD;
&#xD;
          9. Are currently taking a vitamin or nutritional supplement containing a dose of&#xD;
             niacin/nicotinic acid above 100 mg/day.&#xD;
&#xD;
         10. Are currently receiving treatment with any of the following medications:&#xD;
&#xD;
               1. Anticoagulants&#xD;
&#xD;
               2. Statins&#xD;
&#xD;
               3. Antihypertensives&#xD;
&#xD;
         11. Are currently receiving treatment for Type 1 or Type 2 diabetes&#xD;
&#xD;
         12. Have a history of allergic reactions to NIASPAN or any of its non-medicinal&#xD;
             ingredients (methylcellulose, povidone, stearic acid), niacin or nicotinic acid&#xD;
&#xD;
         13. Are currently participating in any other investigational drug study&#xD;
&#xD;
         14. Are a professional or staff member affiliated with the Nova Scotia Early Psychosis&#xD;
             Program or are an immediate family member defined as spouse, parent, child, sibling,&#xD;
             grandparent or grandchild&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heather I Milliken, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nova Scotia Health Authority</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NS Early Psychosis Program</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>August 6, 2015</last_update_submitted>
  <last_update_submitted_qc>August 6, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psychotic Disorders</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Niacin</mesh_term>
    <mesh_term>Nicotinic Acids</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01720095
org study id: CDHA_RS/2010-116
nct id: NCT01720095
nct alias: NCT01041053
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
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
description: Outcomes will be measured by comparison of pre-treatment, post-treatment and twelve month
arm group label: Niaspan
arm group type: Experimental
description: these are the first episode psychosis patients that are randomized to receive niaspan
arm group label: healthy control
arm group type: No Intervention
description: this is the group of healthy controls for cognitive outcome measures
arm group label: first episode control group
arm group type: No Intervention
description: first episode psychosis patients who are randomized to no intervention
intervention type: Drug
intervention name: Niaspan
arm group label: Niaspan
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Heather I Milliken, MD
role: Principal Investigator
affiliation: Nova Scotia Health Authority
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Psychotic Disorders
mesh term: Mental Disorders
mesh term: Niacin
mesh term: Nicotinic Acids