Status:
COMPLETED
Selective Estrogen Receptor Modulators - A Potential Treatment for Psychotic Symptoms of Schizophrenia
Lead Sponsor:
The Alfred
Collaborating Sponsors:
Stanley Medical Research Institute
National Health and Medical Research Council, Australia
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
FEMALE
45-70 years
Phase:
PHASE4
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 Re...
Detailed Description
Estrogen is hypothesised to be protective for women against early onset of severe symptoms of schizophrenia (Hafner, 1991; Seeman, 1992). This 'estrogen hypothesis' was derived from epidemiological, c...
Eligibility Criteria
Inclusion
- 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.
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, 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00361543
Start Date
August 1 2006
End Date
December 1 2014
Last Update
January 30 2015
Active Locations (1)
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1
Monash Alfred Psychiatry Research Centre
Melbourne, Victoria, Australia, 3004