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

Primary Purpose

Psychosis

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Niaspan
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • NS Early Psychosis Program

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Niaspan

healthy control

first episode control group

Arm Description

these are the first episode psychosis patients that are randomized to receive niaspan

this is the group of healthy controls for cognitive outcome measures

first episode psychosis patients who are randomized to no intervention

Outcomes

Primary Outcome Measures

standardized and experimental measures of attention, memory, and executive function. Measurement tools=MATRICS; DalCAB
Outcomes will be measured by comparison of pre-treatment, post-treatment and twelve month

Secondary Outcome Measures

Full Information

First Posted
October 24, 2012
Last Updated
August 6, 2015
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT01720095
Brief Title
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

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Niaspan
Arm Type
Experimental
Arm Description
these are the first episode psychosis patients that are randomized to receive niaspan
Arm Title
healthy control
Arm Type
No Intervention
Arm Description
this is the group of healthy controls for cognitive outcome measures
Arm Title
first episode control group
Arm Type
No Intervention
Arm Description
first episode psychosis patients who are randomized to no intervention
Intervention Type
Drug
Intervention Name(s)
Niaspan
Primary Outcome Measure Information:
Title
standardized and experimental measures of attention, memory, and executive function. Measurement tools=MATRICS; DalCAB
Description
Outcomes will be measured by comparison of pre-treatment, post-treatment and twelve month
Time Frame
change in cognitive function from baseline to 3, 6, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ALL SUBJECTS 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. Must be between the ages of 18 - 35 PATIENTS Within one year of initial DSM 1V TR diagnosis of schizophreniform psychosis, schizophrenia, schizoaffective disorder or psychotic disorder NOS Outpatients 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: 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 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 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 Have unstable medical, psychiatric, neurological or behavioural disorders that may interfere in the conduct or interpretation of the study. 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) Have a past or current history of peptic ulcer, gout or bleeding problems Have a past or current history of hypophosphatemia Have a history of head injury resulting in loss of consciousness of > 5 minutes or other neurological disorder (e.g., seizures, stroke, MS) Are currently taking a vitamin or nutritional supplement containing a dose of niacin/nicotinic acid above 100 mg/day. Are currently receiving treatment with any of the following medications: Anticoagulants Statins Antihypertensives Are currently receiving treatment for Type 1 or Type 2 diabetes Have a history of allergic reactions to NIASPAN or any of its non-medicinal ingredients (methylcellulose, povidone, stearic acid), niacin or nicotinic acid Are currently participating in any other investigational drug study 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather I Milliken, MD
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
NS Early Psychosis Program
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2E2
Country
Canada

12. IPD Sharing Statement

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

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