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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00361543




Registration number
NCT00361543
Ethics application status
Date submitted
7/08/2006
Date registered
8/08/2006
Date last updated
30/01/2015

Titles & IDs
Public title
Selective Estrogen Receptor Modulators - A Potential Treatment for Psychotic Symptoms of Schizophrenia
Scientific title
Selective Estrogen Receptor Modulators - A Potential Treatment for Psychotic Symptoms of Schizophrenia?
Secondary ID [1] 0 0
03T-422
Secondary ID [2] 0 0
MAPrc 94/06
Universal Trial Number (UTN)
Trial acronym
SERM
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 hydrochloride
Other interventions - Lactose Capsules

Active comparator: 1 - Raloxifene Hydrochloride

Placebo comparator: 2 - placebo tablet


Treatment: Drugs: Raloxifene hydrochloride
120 mg per capsule (1 tablet daily)

Other interventions: Lactose Capsules
1 tablet daily for 12 weeks
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PANSS score at trial completion (12 weeks)
Timepoint [1] 0 0
baseline, week 2,4,6,8,10,12
Secondary outcome [1] 0 0
MADRS score at trial completion (12 weeks)
Timepoint [1] 0 0
baseline, week 2,4,6,8,10,12
Secondary outcome [2] 0 0
Cognitive Test scores at trial completion (12weeks)
Timepoint [2] 0 0
baseline and week 12
Secondary outcome [3] 0 0
Adverse Symptom Checklist score at trial completion (12 weeks)
Timepoint [3] 0 0
baseline, week 2,4,6,8,10,12
Secondary outcome [4] 0 0
Hormone level change over study duration (12 weeks)
Timepoint [4] 0 0
baseline, weeks 4, 8, 12

Eligibility
Key inclusion criteria
* Physically well.
* A current DSM-IV diagnosis of schizophrenia or related disorder.
* 45-70 years
* 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
45 Years
Maximum age
70 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
1/08/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
Accrual to date
Final
54
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
Stanley Medical Research Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
National Health and Medical Research Council, Australia
Address [2] 0 0
Country [2] 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 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.

Hypothesis 1: That the women receiving adjunctive Raloxifene 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 placebo group.
Trial website
https://clinicaltrials.gov/study/NCT00361543
Trial related presentations / publications
Thomas N, Gurvich C, Hudaib AR, Gavrilidis E, Kulkarni J. Dissecting the syndrome of schizophrenia: Associations between symptomatology and hormone levels in women with schizophrenia. Psychiatry Res. 2019 Oct;280:112510. doi: 10.1016/j.psychres.2019.112510. Epub 2019 Aug 8.
Kulkarni J, Gavrilidis E, Gwini SM, Worsley R, Grigg J, Warren A, Gurvich C, Gilbert H, Berk M, Davis SR. Effect of Adjunctive Raloxifene Therapy on Severity of Refractory Schizophrenia in Women: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Sep 1;73(9):947-54. doi: 10.1001/jamapsychiatry.2016.1383.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00361543