Status:
COMPLETED
Selective Estrogen Receptor Modulators (SERMs) - A Potential Treatment for Psychotic Symptoms of Schizophrenia in Men?
Lead Sponsor:
The Alfred
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
MALE
18-45 years
Phase:
PHASE4
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 a...
Detailed Description
With the recent advent of selective estrogen receptor modulators (SERMS), such as raloxifene hydrochloride, there is the potential to harness the positive estrogenic effect on central nervous system (...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2019
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01481883
Start Date
January 1 2012
End Date
February 1 2019
Last Update
November 28 2023
Active Locations (1)
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1
Alfred Hospital
Melbourne, Victoria, Australia, 3004