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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04113993




Registration number
NCT04113993
Ethics application status
Date submitted
26/06/2019
Date registered
3/10/2019
Date last updated
28/11/2023

Titles & IDs
Public title
Bazedoxifene -Treatment for Women With Schizophrenia
Scientific title
Bazedoxifene - A New Selective Estrogen Receptor Modulator Treatment for Women With Schizophrenia: a Double-blind, Randomized, Placebo Controlled Trial
Secondary ID [1] 0 0
HREC Reference 47262
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 0 0
Schizophreniform Disorders 0 0
Schizo Affective Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Schizophrenia
Mental Health 0 0 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bazedoxifene Acetate
Treatment: Drugs - Placebo

Experimental: Oral Bazedoxifene - Oral Bazedoxifene dosed at 40 mg daily

Placebo Comparator: Placebo - Identically packaged placebo capsule daily


Treatment: Drugs: Bazedoxifene Acetate
Oral Bazedoxifene dosed at 40 mg daily for 12 weeks

Treatment: Drugs: Placebo
Identically packaged placebo capsule daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Schizophrenia symptoms
Timepoint [1] 0 0
12 Weeks
Secondary outcome [1] 0 0
Cognition
Timepoint [1] 0 0
12 Weeks

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.

- Documented normal PAP smear and pelvic examination in the preceding two years.

- Stable psychotropic medication for previous 4 weeks

- Normal breast ultrasound

- 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
Females
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).

- Women aged 40 or over who have not had a normal mammogram in the last 24 months

- Use of any form of estrogen, progestin or androgen as hormonal therapy in preceding 4
weeks including the pill.

- Pregnant (HCG will be measured at screening)

- Breastfeeding

- 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Alfred Psychiatry Research Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Monash Health
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
To study the effect of adjunctive bazedoxifene - a selective estrogen receptor modulator
(SERM) in a double blind, placebo-controlled adjunctive study in the treatment of women with
schizophrenia. All patients receive standardized antipsychotic medication.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04113993
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anthony de Castella, Applied Scince
Address 0 0
Country 0 0
Phone 0 0
+61 390766564
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04113993