Status:
COMPLETED
The Use of Selective Estrogen Receptor Modulators in the Treatment of Schizophrenia- a Pilot Study
Lead Sponsor:
The Alfred
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
FEMALE
45-70 years
Phase:
PHASE2
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 ...
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, cl...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00206557
Start Date
October 1 2002
End Date
April 1 2007
Last Update
April 23 2007
Active Locations (1)
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1
Alfred Psychiatry Research Centre, Alfred Hospital
Melbourne, Victoria, Australia, 3181