Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001242415
Ethics application status
Approved
Date submitted
1/09/2016
Date registered
6/09/2016
Date last updated
9/12/2020
Date data sharing statement initially provided
9/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Thyroid tests in people who will be taking quetiapine.
Scientific title
The effect of quetiapine on thyroid function test results measured by both immunoassay and LCMSMS, in patients prescribed quetiapine.
Secondary ID [1] 290077 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
The parent study for this trial is registered on ANZCTR.org.au with registration number ACTRN12616001227482p

Health condition
Health condition(s) or problem(s) studied:
Psychosis, treated with quetiapine 300154 0
Mood disorders, treated with quetiapine 300188 0
Agitation, treated with quetiapine 300189 0
Condition category
Condition code
Mental Health 300038 300038 0 0
Anxiety
Mental Health 300057 300057 0 0
Schizophrenia
Mental Health 300058 300058 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Collection of 4 blood specimens from 20 people who are about the start quetiapine and who are expected to continue treatment for at least 6 weeks. During this time, participants will take quetiapine according to their treating doctor's prescription. Doses will not be changed for the purposes of this study. The first specimen is collected before the first dose of quetiapine, then further specimens at day 1, week 3 and week 6.
Each specimen will be 7.5 millilitres, or about one and a half teaspoons volume.
Thyroid function and quetiapine will be measured in the specimens.
Intervention code [1] 295813 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299515 0
Comparison of Free T4 and Free T3 levels as measured by immunoassay and LC-MSMS at 3 and 6 weeks of treatment (co-primary endpoints).
Timepoint [1] 299515 0
3 weeks and 6 weeks
Secondary outcome [1] 327409 0
Secondary: quetiapine concentration as a predictor of immunoassay - LCMSMS assay difference in a mixed effects model.
Timepoint [1] 327409 0
Results from all blood specimens, at 0, 1 day, 3 weeks and 6 weeks
Secondary outcome [2] 327452 0
Exploratory: relationships between immunoassay - LCMSMS assay difference and total T3, T4, TSH and anti-thyroid antibodies.
Timepoint [2] 327452 0
Results from all blood specimens, at 0, 1 day, 3 weeks and 6 weeks

Eligibility
Key inclusion criteria
20 patients who are about to start taking quetiapine on a daily basis, and who are expected to still be taking it in 6 weeks time. Patients taking quetiapine for any indication may be recruited.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Analysis of primary outcome measure from 20 participants: Initially, 2-way ANOVA or mixed effects modelling, as appropriate, followed by specific comparisons, On the assumption that fT4 population variance is similar when measured by immunoassay and LCMSMS, a paired analysis of 40 specimens will have a power of 0.87 to detect a difference of 1.25 pm/L in fT4 at p = 0.05 on 2-tailed paired t-test, Measurements of bias and 95% limits of agreement will be determined and displayed on Bland-Altman plots.
The slope of the regression line between concentrations reported by the two methodologies and the surrounding 95% confidence intervals will be calculated by linear regression. If the immunoassay and LCMSMS assay are shown to return systematically different values, an exploratory analysis will follow to estimate the effect of quetiapine concentration as a covariate in multiple regression.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/09/2016
Actual
30/09/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 6608 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 14215 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 294446 0
Government body
Name [1] 294446 0
PathWest Laboratory Medicine
Country [1] 294446 0
Australia
Primary sponsor type
Government body
Name
PathWest Laboratory Medicine
Address
Locked Bag 2009,
Nedlands, WA, 6009
Country
Australia
Secondary sponsor category [1] 293300 0
None
Name [1] 293300 0
Address [1] 293300 0
Country [1] 293300 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295876 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [1] 295876 0
Ethics committee country [1] 295876 0
Australia
Date submitted for ethics approval [1] 295876 0
01/05/2016
Approval date [1] 295876 0
19/08/2016
Ethics approval number [1] 295876 0
2015-169

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68782 0
Dr Rhonda Maguire
Address 68782 0
Department of Clinical Pharmacology & Toxicology,
PathWest Laboratory Medicine,
Locked Bag 2009,
Nedlands, WA 6009
Country 68782 0
Australia
Phone 68782 0
+618 63834151
Fax 68782 0
Email 68782 0
rhonda.maguire@health.wa.gov.au
Contact person for public queries
Name 68783 0
Rhonda Maguire
Address 68783 0
Department of Clinical Pharmacology & Toxicology,
PathWest Laboratory Medicine,
Locked Bag 2009,
Nedlands, WA 6009
Country 68783 0
Australia
Phone 68783 0
+618 63834151
Fax 68783 0
Email 68783 0
rhonda.maguire@health.wa.gov.au
Contact person for scientific queries
Name 68784 0
Rhonda Maguire
Address 68784 0
Department of Clinical Pharmacology & Toxicology,
PathWest Laboratory Medicine,
Locked Bag 2009,
Nedlands, WA 6009
Country 68784 0
Australia
Phone 68784 0
+618 63834151
Fax 68784 0
Email 68784 0
rhonda.maguire@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.