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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01481883




Registration number
NCT01481883
Ethics application status
Date submitted
16/11/2011
Date registered
30/11/2011
Date last updated
9/01/2020

Titles & IDs
Public title
Selective Estrogen Receptor Modulators (SERMs) - A Potential Treatment for Psychotic Symptoms of Schizophrenia in Men?
Scientific title
A Randomised Controlled Trial of Selective Estrogen Receptor Modulators (SERMs) - A Potential Treatment for Psychotic Symptoms of Schizophrenia in Men?
Secondary ID [1] 0 0
486/11
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 Hydrochloride
Treatment: Drugs - Placebo

Experimental: Raloxifene Hydrochloride 120mg oral per day - 120mg raloxifene plus antipsychotic drug

Placebo Comparator: Placebo tablet - one per day - Lactose pill plus antipsychotic medication


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

Treatment: Drugs: Placebo
1 capsule daily for 12 week trial

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

Outcomes
Primary outcome [1] 0 0
Change from Baseline to 12 week follow up in PANSS-positive and negative syndrome scale - Positive and Negative Symptom Schedule (PANSS): The PANSS will be performed at baseline and at weeks 2,4,6,8,10 and 12. The PANSS consists of a Positive Scale (7 positive symptom constructs), a Negative Scale (7 negative symptom constructs) and a General Psychopathology Scale (16 symptom constructs). For each patient, the scale will be administered by the same trained rater. The PANSS provides a well standardised method of evaluating and monitoring psychotic symptoms. The rater is trained and recertified against an internationally recognised "gold standard".
Timepoint [1] 0 0
baseline, week2, week4, week 6, week 8, week 10, week 12
Secondary outcome [1] 0 0
Montgomery Asberg Depression Rating Scale (MADRS): - Montgomery Asberg Depression Rating Scale (MADRS): The MADRS will be performed at baseline, then at weeks 2,4,6,8,10 and 12. Many patients with schizophrenia have co-existing depression, hence monitoring of depression is important.
Timepoint [1] 0 0
baseline, week2, week4, week 6, week 8, week 10, week 12
Secondary outcome [2] 0 0
MATRICS Consensus Cognitive Battery - MATRICS Consensus Cognitive Battery (MCCB): The MATRICS test battery will be conducted at baseline and at study completion to quantify changes in cognitive functioning. This standardized battery assess the key separable cognitive deficits in schizophrenia and has a high test-retest reliability. The MATRICS comprises 7 Domains of which we will be assessing speed of processing, working memory, verbal learning, visual learning and reasoning and problem solving.
Timepoint [2] 0 0
Baseline, week 12
Secondary outcome [3] 0 0
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) - A neuropsychological test battery will be conducted at baseline and study completion to quantify changes in cognitive functioning. The RBANS comprises 12 subtests that are used to calculate five index scores (Immediate Memory; Visuospatial/Constructional; Language; Attention and Delayed Memory) and a total score. There are alternate forms to be used at each time point to avoid practice effects. The inclusion of the RBANS will allow direct comparisons in cognitive functioning with our other estrogen trials.
Timepoint [3] 0 0
Baseline, week 12

Eligibility
Key inclusion criteria
- Physically well

- DSM-IV diagnosis of schizophrenia, schizoaffective or schizophreniform

- 18- 45 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
Minimum age
18 Years
Maximum age
45 Years
Gender
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 any significant unstable medical illness such as epilepsy and diabetes
or known active cardiac, renal or liver disease; presence of illness causing
immobilization.

- 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 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The aim of this project is to investigate the effect of Raloxifene 120mg in men with
schizophrenia. This trial will adopt a 12 week randomised controlled model.

Hypotheses 1: That the men receiving adjunctive selective estrogen receptor modulators (SERM)
will have a significantly greater reduction in psychosis symptoms over the course of the
study than men receiving adjunctive placebo.

Hypotheses 2: That the men receiving adjunctive SERM will have a significantly greater
improvement in cognitive function than men receiving adjunctive placebo
Trial website
https://clinicaltrials.gov/show/NCT01481883
Trial related presentations / publications
Kulkarni J, de Castella A, Headey B, Marston N, Sinclair K, Lee S, Gurvich C, Fitzgerald PB, Burger H. Estrogens and men with schizophrenia: is there a case for adjunctive therapy? Schizophr Res. 2011 Feb;125(2-3):278-83. doi: 10.1016/j.schres.2010.10.009. Epub 2010 Nov 9.
Public notes

Contacts
Principal investigator
Name 0 0
Jayashri Kulkarni, Phd,FRANZCP
Address 0 0
Monash Alfred Psychiatry Research Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Emmy Gavrilidis, BaAppSci
Address 0 0
Country 0 0
Phone 0 0
+61 3 9076 6913
Fax 0 0
Email 0 0
emmy.gavrilidis@monash.edu
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01481883