Ignite Creation Date:
2025-12-24 @ 1:47 PM
Ignite Modification Date:
2025-12-30 @ 1:46 AM
Study NCT ID:
NCT01720095
Status:
COMPLETED
Last Update Posted:
2015-08-07
First Post:
2012-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Niapsan as Add -on Therapy to Antipsychotic Treatment in First Episode Psychosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009525', 'term': 'Niacin'}], 'ancestors': [{'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-06', 'studyFirstSubmitDate': '2012-10-24', 'studyFirstSubmitQcDate': '2012-10-31', 'lastUpdatePostDateStruct': {'date': '2015-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'standardized and experimental measures of attention, memory, and executive function. Measurement tools=MATRICS; DalCAB', 'timeFrame': 'change in cognitive function from baseline to 3, 6, and 12 months', 'description': 'Outcomes will be measured by comparison of pre-treatment, post-treatment and twelve month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Psychosis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nALL SUBJECTS\n\n1. 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.\n2. Must be between the ages of 18 - 35\n\nPATIENTS\n\n1. Within one year of initial DSM 1V TR diagnosis of schizophreniform psychosis, schizophrenia, schizoaffective disorder or psychotic disorder NOS\n2. Outpatients\n3. 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.\n\nHEALTHY CONTROLS\n\n1\\. Age-matched to experimental groups\n\nExclusion Criteria:\n\n1. 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\n2. 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\n3. 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\n4. Have unstable medical, psychiatric, neurological or behavioural disorders that may interfere in the conduct or interpretation of the study.\n5. 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)\n6. Have a past or current history of peptic ulcer, gout or bleeding problems\n7. Have a past or current history of hypophosphatemia\n8. Have a history of head injury resulting in loss of consciousness of \\> 5 minutes or other neurological disorder (e.g., seizures, stroke, MS)\n9. Are currently taking a vitamin or nutritional supplement containing a dose of niacin/nicotinic acid above 100 mg/day.\n10. Are currently receiving treatment with any of the following medications:\n\n 1. Anticoagulants\n 2. Statins\n 3. Antihypertensives\n11. Are currently receiving treatment for Type 1 or Type 2 diabetes\n12. Have a history of allergic reactions to NIASPAN or any of its non-medicinal ingredients (methylcellulose, povidone, stearic acid), niacin or nicotinic acid\n13. Are currently participating in any other investigational drug study\n14. 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'}, 'identificationModule': {'nctId': 'NCT01720095', 'briefTitle': 'Niapsan as Add -on Therapy to Antipsychotic Treatment in First Episode Psychosis', 'nctIdAliases': ['NCT01041053'], 'organization': {'class': 'OTHER', 'fullName': 'Nova Scotia Health Authority'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CDHA_RS/2010-116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Niaspan', 'description': 'these are the first episode psychosis patients that are randomized to receive niaspan', 'interventionNames': ['Drug: Niaspan']}, {'type': 'NO_INTERVENTION', 'label': 'healthy control', 'description': 'this is the group of healthy controls for cognitive outcome measures'}, {'type': 'NO_INTERVENTION', 'label': 'first episode control group', 'description': 'first episode psychosis patients who are randomized to no intervention'}], 'interventions': [{'name': 'Niaspan', 'type': 'DRUG', 'armGroupLabels': ['Niaspan']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3H 2E2', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'NS Early Psychosis Program', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'overallOfficials': [{'name': 'Heather I Milliken, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nova Scotia Health Authority'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nova Scotia Health Authority', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}