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
About this trial
This is an interventional treatment trial for Psychosis
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
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
NCT ID
NCT01720095
First Posted
October 24, 2012
Last Updated
August 6, 2015
Sponsor
Nova Scotia Health Authority
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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