Niapsan as Add -on Therapy to Antipsychotic Treatment in First Episode Psychosis
This study is currently recruiting participants.
Verified October 2012 by Capital District Health Authority, Canada
Sponsor:
Capital District Health Authority, Canada
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
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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
- 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
Contacts and Locations
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 Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Hypolipidemic Agents Antimetabolites |
Molecular Mechanisms of Pharmacological Action Lipid Regulating 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 June 18, 2013