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

August 6, 2015 updated by: Nova Scotia Health Authority

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2E2
        • NS Early Psychosis Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nova Scotia Health Authority

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heather I Milliken, MD, Nova Scotia Health Authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CDHA_RS/2010-116

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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