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

NCT01720095 | Completed Phase 3

• 1 other identifier: CDHA_RS/2010-116
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychosis

Outcome Measures

Primary Outcomes (1)

• 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

  change in cognitive function from baseline to 3, 6, and 12 months

Study Arms (3)

Niaspan

EXPERIMENTAL

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

Drug: Niaspan

healthy control

NO INTERVENTION

this is the group of healthy controls for cognitive outcome measures

first episode control group

NO INTERVENTION

first episode psychosis patients who are randomized to no intervention

Interventions

Niaspan DRUG

Niaspan

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• \. Age-matched to experimental groups

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

NS Early Psychosis Program

Halifax, Nova Scotia, B3H 2E2, Canada

Location

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Niacin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Heather I Milliken, MD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: November 2, 2012
• Study Start: October 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 7, 2015

Record last verified: 2012-10

Locations

CA (1)