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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/NCT00206557




Registration number
NCT00206557
Ethics application status
Date submitted
13/09/2005
Date registered
21/09/2005
Date last updated
23/04/2007

Titles & IDs
Public title
The Use of Selective Estrogen Receptor Modulators in the Treatment of Schizophrenia- a Pilot Study
Scientific title
The Use of Selective Estrogen Receptor Modulators in the Treatment of Schizophrenia- a Pilot Study
Secondary ID [1] 0 0
03T-422
Secondary ID [2] 0 0
APRC 146/02
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
Schizophreniform 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
Treatment: Drugs - Estradiol/dyhydroprogestrone

Treatment: Drugs: Raloxifene


Treatment: Drugs: Estradiol/dyhydroprogestrone
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PANSS score at trial completion (12 weeks)
Timepoint [1] 0 0
Secondary outcome [1] 0 0
MADRS score at trial completion (12 weeks)
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Cognitive Test scores at trial completion (12 weeks)
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Adverse Symptom Checklist score at trial completion (12 weeks)
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Hormone level change over study period (12 weeks)
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
- Female aged over 45 years

- Current diagnosis of DSM-IV Schizophrenia, Schizoaffective or Schizophreniform
Disorder

- Symptom rating greater than 60 on the PANSS at baseline/screening

- Patient able to give informed consent

- Patient post menopausal (confirmed by hormone assay and Greene Climacteric Scale plus
Menstrual Cycle Questionnaire)
Minimum age
45 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Clinically significant concomitant medical or neurological condition or history of
venous thromboembolic event

- High suicide/aggression Risk in the opinion of the investigator.

- If patient's psychotic illness is directly related to illicit substance abuse or has a
history of substance abuse or dependence in the past 6 months

- Smoking more than 20 cigarettes per day

- Use of any form of hormones or hormone therapy

- Illness causing immobilisation

- Undiagnosed postmenopausal vaginal bleeding

- Consumption of more than 30gm of alcohol (3 standard drinks)per day.

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?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
1/10/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2007
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Psychiatry Research Centre, Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Stanley Medical Research Institute
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) as a
treatment for schizophrenia in postmenopausal women. Raloxifene is a selective estrogen
receptor modulator (SERM) which means that it can affect the central nervous system effects
of estrogen (eg: improving emotional symptoms, memory, information processing and
concentration), without adversely affecting reproductive tissue / organs such as breast,
uterus and ovaries.We are conducting a double blind placebo controlled 3 month duration study
comparing the psychotic symptom response between three groups of postmenopausal women with
schizophrenia. One group will receive standard antipsychotic medication plus 60mg Raloxifene,
the second group receives standard antipsychotic medication plus Hormone Therapy(estradiol
2mg oral per day + dyhydroprogesterone 10mg oral per day) and the third group receives
standard antipsychotic medication plus oral placebo. Hypothesis 1: That the women receiving
adjunctive raloxifene or HT would have a quicker recovery from psychotic symptoms, as
measured on the rating scales, compared with the women receiving adjunctive
placebo.Hypothesis 2: That the Raloxifene group would have better cognitive improvement than
the other two groups.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00206557
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jayashri Kulkarni, MBBS, MPM, FRANZCP, PHD
Address 0 0
Bayside Health; Alfred Hospital
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