Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001471178p
Ethics application status
Submitted, not yet approved
Date submitted
3/09/2019
Date registered
23/10/2019
Date last updated
23/10/2019
Date data sharing statement initially provided
23/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Bazedoxifene – A New Selective Estrogen Receptor Modulator Treatment for Men with Schizophrenia
Scientific title
Bazedoxifene – A New Selective Estrogen Receptor Modulator Treatment for Men with Schizophrenia: a double-blind, randomized, placebo controlled trial
Secondary ID [1] 299171 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 314259 0
Condition category
Condition code
Mental Health 312614 312614 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Bazedoxifene capsule dosed at 40 mg (once daily) for 12 weeks. We only dispense medication fortnightly and ask for any unused medication to be returned. Adherence is monitored through follow up telephone calls on a fornightly or weekly basis.
Intervention code [1] 315462 0
Treatment: Drugs
Comparator / control treatment
Oral placebo (an inert substance with no active ingredients), Lactose and Capsugels
Control group
Placebo

Outcomes
Primary outcome [1] 321263 0
Change in psychopathology scores using the Positive and Negative Syndrome Scale (PANSS), Montgomery Asberg Depression Rating Scale (MADRS) and the Depression, Anxiety and Stress Scale (DASS-21)
Timepoint [1] 321263 0
12 weeks post commencement of intervention
Secondary outcome [1] 374478 0
Change in neuropsychological performance
Timepoint [1] 374478 0
12 weeks post commencement of intervention using the MATRICS Consensus Cognitive Battery (MCCB), the Controlled Oral Word Association Task (COWAT), Trails A and B, the Test of Premorbid Functioning (TOPF) and eye tracking measures using the EyeLink Portable Duo
Secondary outcome [2] 375927 0
HPG Hormones levels: Bioactive sex steroids will be measured from both saliva and blood samples using gold standard analysis liquid chromatography tandem mass spectrometry.
This is an exploratory outcome (e.g. estrogen, progesterone, allopregnanolone, FSH, LH, DHEA)
Timepoint [2] 375927 0
12 weeks post commencement of intervention
Secondary outcome [3] 375928 0
Change in peripheral gene expression: Peripheral blood samples (DNA and mRNA collected) using exploratory high-throughput microarray analyses.
Timepoint [3] 375928 0
12 weeks post commencement of intervention
Secondary outcome [4] 375929 0
Changes in inflammatory and growth factor markers analysed from peripheral blood samples. This is an exploratory outcome (e.g. IL6 (interleukin 6) and BDNF)
Timepoint [4] 375929 0
12 weeks post commencement of intervention
Secondary outcome [5] 376142 0
HPA hormone levels: Cortisol awakening response measured with saliva collected on waking and at 30 and 60 minutes post-waking using immunoassays (ELISA technology).
Timepoint [5] 376142 0
12 weeks post commencement of intervention

Eligibility
Key inclusion criteria
• Physically well.
• A current DSM-V diagnosis of schizophrenia or related disorder.
• 18- 65 years
• Able to give informed consent.
• PANSS total score between 40 and 90 and a score of 4 (moderate) or more on two or more of the following PANSS items: delusions, hallucinatory behaviour, conceptual disorganization or suspiciousness.
• Stable psychotropic medication for previous 4 weeks
• IQ > 70 (as determined by the WAIS IV subtests)
• English language proficiency (in order to provide informed consent and complete cognitive test battery)
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with known abnormalities in the hypothalamo-pituitary gonadal axis, thyroid dysfunction, central nervous system tumours, active or past history of a venous thromboembolic event.
• Patients with a history of severe traumatic brain injury or significant neurological or unstable medical illness such as epilepsy and diabetes or known active cardiac, renal or liver disease; presence of illness causing immobilisation.
• Patients whose psychotic illness is directly related to illicit substance use or who have a history of substance dependence during the last six months (with the exclusion of caffeine and/or nicotine dependence).
• Use of any form of estrogen, progestin or androgen as hormonal therapy in preceding 4 weeks including the pill.
• Planned changes to psychotropic medication or psychotherapy regimen.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 303712 0
Other
Name [1] 303712 0
Philantropic Donor
Country [1] 303712 0
Australia
Primary sponsor type
University
Name
Monash University Foundation
Address
Wellington Road, Clayton, Victoria 3800, Australia
Country
Australia
Secondary sponsor category [1] 303825 0
None
Name [1] 303825 0
Address [1] 303825 0
Country [1] 303825 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304239 0
ALFRED HEALTH HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 304239 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 304239 0
Australia
Date submitted for ethics approval [1] 304239 0
04/09/2019
Approval date [1] 304239 0
Ethics approval number [1] 304239 0

Summary
Brief summary
Despite advances in the treatment of schizophrenia, pharmacotherapy remains sub-optimal, and the prognosis for many patients is poor. Estradiol has a positive role in the treatment of psychosis symptoms and cognitive deficits seen in people with schizophrenia, but it has become clear that long-term use of estradiol with progesterone may have associated increased risks of breast and other cancers. Bazedoxifene, a third generation Selective Estrogen Receptor Modulator (SERM), appears to be safer with respect to long term use than older SERMs, has additional actions on the glucocorticoid receptor, and together this different pharmacology speculatively has greater potential than other SERMs to impact favorably on both psychosis symptoms and cognition in men and women with schizophrenia. This study will test 100 men to determine if bazedoxifene, as an adjunctive hormone modulator, is effective for positive and cognitive symptoms of schizophrenia. We hypothesise that bazedoxifene will significantly reduce psychopathology and will significantly improve cognition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96242 0
Prof Jayashri Kulkarni
Address 96242 0
Monash Alfred Psychiatry research centre (MAPrc)
Level 4, 607 St Kilda Road
Melbourne 3004
Victoria
Country 96242 0
Australia
Phone 96242 0
+61 03 9076 6924
Fax 96242 0
Email 96242 0
[email protected]
Contact person for public queries
Name 96243 0
Jayashri Kulkarni
Address 96243 0
Monash Alfred Psychiatry research centre (MAPrc)
Level 4, 607 St Kilda Road
Melbourne 3004
Victoria
Country 96243 0
Australia
Phone 96243 0
+61 03 9076 6924
Fax 96243 0
Email 96243 0
[email protected]
Contact person for scientific queries
Name 96244 0
Jayashri Kulkarni
Address 96244 0
Monash Alfred Psychiatry research centre (MAPrc)
Level 4, 607 St Kilda Road
Melbourne 3004
Victoria
Country 96244 0
Australia
Phone 96244 0
+61 03 9076 6924
Fax 96244 0
Email 96244 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Adherence to Alfred ethics. Only group data will be available.


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.