Status:
COMPLETED
Clinical Estradiol Trial in Women With Schizophrenia
Lead Sponsor:
Bayside Health
Collaborating Sponsors:
National Alliance for Research on Schizophrenia and Depression
Stanley Medical Research Institute
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
To investigate the 'estrogen-protection' hypothesis by comparing changes in psychotic symptoms between one group of patients receiving standard antipsychotic drug treatment plus placebo and a second m...
Detailed Description
BACKGROUND: Schizophrenia is a severe mental disorder that affects up to two percent of the adult population. Patients present with a variety of symptoms including hallucinations, delusions and bizar...
Eligibility Criteria
Inclusion
- Female patients of potential child-bearing age (Pre-menopausal and Post-menarche)
- Female patients who have a current diagnosis of Schizophrenia, Schizophreniform Disorder, or Schizoaffective Disorder (not in manic phase)
- Female patients who score more than or equal to 60 on PANSS rating scale
- Female patients who are able to give informed consent
Exclusion
- Female patients who are pregnant or lactating.
- Female patients with known severe abnormalities in the hypothalamo-pituitary gonadal axis, thyroid dysfunction, central nervous system tumours, or other serious medical conditions which would contraindicate estrogen use.
- Female patients already taking estrogen preparations such as the oral contraceptive pill
- Post-menopausal or pre-menarche female patients.
- Female patients whose psychotic illness is due to illicit drugs or who have a history of consistent substance abuse or dependence during the last 6 months.
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2004
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00206570
Start Date
January 1 2001
End Date
December 1 2004
Last Update
February 4 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Bayside Health - The Alfred Hospital
Melbourne, Victoria, Australia, 3181