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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/NCT02354001




Registration number
NCT02354001
Ethics application status
Date submitted
27/01/2015
Date registered
3/02/2015
Date last updated
9/01/2020

Titles & IDs
Public title
Selective Estrogen Receptor Modulators for Women of Child-bearing Age With Schizophrenia
Scientific title
Selective Estrogen Receptor Modulators (SERMs) - A Potential New Treatment for Women of Child-bearing Age With Psychotic Symptoms of Schizophrenia
Secondary ID [1] 0 0
94/06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 0 0
Schizoaffective 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 - Raloxifene hydrochloride
Treatment: Drugs - Placebo

Experimental: Raloxifene Hydrochloride - 120 mg per capsule (1 tablet daily)

Placebo Comparator: placebo tablet - 1 tablet daily for 12 weeks


Treatment: Drugs: Raloxifene hydrochloride
120mg daily- 1 capsule for 12 week trial

Treatment: Drugs: Placebo
1 capsule daily for 12 week trial - lactose
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in Positive and Negative Syndrome Scale (PANSS)
Timepoint [1] 0 0
baseline and 12 weeks
Secondary outcome [1] 0 0
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) score
Timepoint [1] 0 0
baseline and 12 weeks
Secondary outcome [2] 0 0
Change from baseline in Cognitive Test scores- MATRICS Consensus Cognitive Battery (MCCB) and Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS)
Timepoint [2] 0 0
baseline and 12 weeks

Eligibility
Key inclusion criteria
- Physically well

- A current DSM-IV diagnosis of schizophrenia or related disorder.

- 18- 45 years

- Premenopausal (regular menstrual cycles and follicle stimulating hormone < 40 mIU/ml;
for hysterectomised women, FSH< 40mIU/ml and estradiol> 120pmol/L)

- Able to give informed consent.

- PANSS total score > 60 (1 - 7 scale) and a score of 4 (moderate) or more on two or
more of the following PANSS items: delusions, hallucinatory behaviour, conceptual
disorganization or suspiciousness.

- No abnormality observed during physical breast examination.

- Documented normal PAP smear and pelvic examination in the preceding two years.
Minimum age
18 Years
Maximum age
45 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, or undiagnosed vaginal bleeding.

- Patients with any significant 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 abuse or dependence during the last six months, or
consumption of more than 30gm of alcohol (three standard drinks) per day.

- Smoking more than 20 cigarettes per day.

- Use of any form of estrogen, progestin or androgen as hormonal therapy, or
antiandrogen including tibolone or use of phytoestrogen supplements as powder or
tablet.

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2019
Sample size
Target
80
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

Ethics approval
Ethics application status

Summary
Brief summary
The aim of the project is to investigate the use of Raloxifene (a new form of estrogen) in
the treatment of young women with schizophrenia and schizoaffective disorder. Raloxifene is a
Selective Estrogen Receptor Modulator (SERM),which means that it can affect the central
nervous system (CNS) effects of estrogen (eg. improving emotional symptoms, memory,
information processing and concentration), without adversely affecting reproductive
tissue/organs such as breast, uterus and ovaries. The investigators are conducting a
double-blind, placebo controlled, three month study comparing the psychotic symptom response
of women with schizophrenia in both groups. One group will receive standard antipsychotic
medication plus 120mg Raloxifene, while the second group will receive standard antipsychotic
medication plus oral placebo.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02354001
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries