NCT01324297|Terminated
Study Stopped
Unable to secure funding for second phase of study (i.e., niacin skin flush test in early psychosis patients).
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Unable to secure funding for second phase of study (i.e., niacin skin flush test in early psychosis patients).
Sponsor study identifier
observational
107
1 country
1
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2016
Actual (reported)Study Completion
July 2016
Actual (reported)The purpose of this study is to gather normative data from healthy adults and to determine a sensitive and specific cut-off value for responders and non-responders to the Niacin Skin Flush Test in a sample of first episode psychosis patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 24, 2011
Actual (reported)March 29, 2011
Actual (reported)December 2011
Date type not reportedThis date has not been verified as actual or estimated.
July 2016
Actual (reported)July 2016
Actual (reported)change in visual rating of skin response (redness and oedema)
A 7-point visual rating scale, previously tested for reliability (Kerr 2008), to visually rate the skin response to aqueous methyl nicotinate (niacin) with respect to both redness and oedema as a function of increasing niacin concentrations.Ratings will be acquired every three minutes over a 12-minute period starting at the time of solution application.
ratings made at 3, 6, 9 and 12 minutes after application of methyl nicotinate
Caucasian males and females between 19 and 30 years of age.
Caucasian males and females between 19 and 30 years of age within twelve months of initial DSM IV TR diagnosis of schizophreniform psychosis, schizophrenia, schizoaffective disorder or psychotic disorder NOS.
four patches of 2 x 3cm thin blotting paper will be soaked with an equivalent amount (0.1 mL) of aqueous methyl nicotinate in four different concentrations: 0.1, 0.01, 0.001, 0.0001 M. The four patches will then be applied at the same time to the inner forearm for 60 seconds.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Healthy young adults
Nova Scotia First Episode Psychosis Program; QEII health Sciences Centre; Capital District Health Authority
Halifax, Nova Scotia, B3H 2E2, Canada
Kerr M, Cotton S, Proffitt T, McConchie M, Markulev C, Smesny S, McGorry P, Berger G. The topical niacin sensitivity test: an inter- and intra-rater reliability study in healthy controls. Prostaglandins Leukot Essent Fatty Acids. 2008 Jul-Aug;79(1-2):15-9. doi: 10.1016/j.plefa.2008.06.001. Epub 2008 Jul 24.
Nadalin S, Buretic-Tomljanovic A, Rubesa G, Tomljanovic D, Gudelj L. Niacin skin flush test: a research tool for studying schizophrenia. Psychiatr Danub. 2010 Mar;22(1):14-27.
Phillip G Tibbo, MD, FRCPC
Capital District Health Authority, Nova Scotia, Canada
107 participants (actual enrollment reported by the registry).
First Submitted
March 24, 2011
First Posted
March 29, 2011
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
Social Cognitive Training for Psychosis: Treatment Development
Contact the study team to confirm eligibility.
Primary Completion
July 2016
Actual (reported)Study Completion
July 2016
Actual (reported)Last Updated
July 28, 2016
Record last verified: 2016-07
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Source: ClinicalTrials.gov.
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