Psychotic DisordersNCT01324297
The Topical Niacin Skin Flush Test in First Episode Psychosis
An observational study of Psychotic Disorders and Schizophrenia, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychotic Disorders, Schizophrenia
- What is being tested?
- skin test
- Type of treatment
- Injection or infusion
- How many people
- 107 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2011to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy young adults
Who may be able to join
- caucasian
- within twelve months of initial DSM IV TR diagnosis of schizophreniform psychosis, schizophrenia, schizoaffective disorder or psychotic disorder NOS
- outpatient
Who cannot join
- known allergy to study compound (methyl nicotinate, vitamin B3, niacin)
- skin conditions (e.g., dermatitis, psoriasis, eczema)
- diagnosis or treatment for medical conditions that may affect normal vascular tone (e.g., diabetes, vasculitis, chronic hypertension, etc.)
- Use of anti-inflammatory, antibiotic, or antihistamine medications within one month prior to study entry
- Use of supplements like Omega 3 fatty acids within 3 months prior to study entry
- Use of vitamin or nutritional supplement containing a dose of niacin/nicotinic acid above 50 mg/day at study entry
Trial locations and contacts
1 site in 1 country.
Canada1 site
Nova Scotia First Episode Psychosis Program; QEII health Sciences Centre; Capital District Health Authority
Halifax, Nova Scotia, B3H 2E2
About this study
Official title: The Topical Niacin Skin Flush Test: A Means for Longitudinal Monitoring of Two Different Biological Subgroups of Patients With First Episode Psychosis
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.
- Conditions
- Psychotic Disorders, Schizophrenia
- Being tested
- skin test
- Keywords
- Diagnostic Techniques and Procedures, Sensitivity and Specificity, Skin Tests, Biological Markers
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin testOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Caucasian males and females between 19 and 30 years of age. Receives: Other: skin test | |
| First Episode Psychosis | 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. Receives: Other: skin test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ratings made at 3, 6, 9 and 12 minutes after application of methyl nicotinate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startDec 2011
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: Unable to secure funding for second phase of study (i.e., niacin skin flush test in early psychosis patients).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beverly Butler, Nova Scotia Health Authority
- Investigators
- Phillip G Tibbo, MD, FRCPC, Study chair, Capital District Health Authority, Nova Scotia, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324297
- Sponsor's protocol ID
- CDHA-RS_2011-215
- Status last verified
- Jul 2016
- First submitted
- 24 Mar 2011
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18656334Nadalin 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.
PubMed 20305586
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Topical Niacin Skin Flush Test: A Means for Longitudinal Monitoring of Two Different Biological Subgroups of Patients With First Episode Psychosis
- ClinicalTrials.gov ID
- NCT01324297
- Acronym / sponsor ID
- CDHA-RS_2011-215
- Conditions
- Psychotic Disorders, Schizophrenia
- Keywords
- Diagnostic Techniques and Procedures, Sensitivity and Specificity, Skin Tests, Biological Markers
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to secure funding for second phase of study (i.e., niacin skin flush test in early psychosis patients).
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | – | Other: skin testCaucasian males and females between 19 and 30 years of age. |
| First Episode Psychosis | – | Other: skin testCaucasian 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. |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy young adults
Key inclusion criteria (3 listed)
- caucasian
- within twelve months of initial DSM IV TR diagnosis of schizophreniform psychosis, schizophrenia, schizoaffective disorder or psychotic disorder NOS
- outpatient
Key exclusion criteria (6 listed)
- known allergy to study compound (methyl nicotinate, vitamin B3, niacin)
- skin conditions (e.g., dermatitis, psoriasis, eczema)
- diagnosis or treatment for medical conditions that may affect normal vascular tone (e.g., diabetes, vasculitis, chronic hypertension, etc.)
- Use of anti-inflammatory, antibiotic, or antihistamine medications within one month prior to study entry
- Use of supplements like Omega 3 fatty acids within 3 months prior to study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin testfour 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. | Other | First Episode Psychosis, Healthy Control |
Primary outcome
change in visual rating of skin response (redness and oedema)
Time frame: ratings made at 3, 6, 9 and 12 minutes after application of methyl nicotinate
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.
Results and safety
The study was stopped early (reason given: Unable to secure funding for second phase of study (i.e., niacin skin flush test in early psychosis patients).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
- Background: PubMed 18656334Kerr 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.
- Background: PubMed 20305586Nadalin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phillip G Tibbo, MD, FRCPC study chair
Capital District Health Authority, Nova Scotia, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychotic Disorders and Schizophrenia, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to secure funding for second phase of study (i.e., niacin skin flush test in early psychosis patients).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in visual rating of skin response (redness and oedema) (time frame: ratings made at 3, 6, 9 and 12 minutes after application of methyl nicotinate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01324297, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2016.