Status:
COMPLETED
A Definitive Estrogen Patch Study (ADEPT)
Lead Sponsor:
The Alfred
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
Brief Summary
OBJECTIVE: To test the use of adjunctive estrogen in a 8 week, three-arm, double-blind, placebo-controlled study in the treatment of psychotic symptoms in women with schizophrenia. HYPOTHESIS: That...
Detailed Description
This research protocol outlines a multi-site clinical trial of adjunctive estradiol in women with Schizophrenia. We propose to recruit 180 women into this study from 3 Australian sites - The Alfred Ho...
Eligibility Criteria
Inclusion
- Female participants of potential child-bearing age (Pre-menopausal and Post-menarche)
- Female participants who meet the MINI (Mini International Neuropsychiatric Interview for DSM-IV) diagnostic criteria for current psychotic disorder or have a current DSM-IV diagnosis of Schizophrenia, Schizophreniform Disorder, or Schizoaffective Disorder (not in manic phase).
- Female participants with a PANSS positive score greater than 15 and/or a PANSS negative score greater than 15.
- Female participants who are able to give informed consent
- Female participants receiving 2-20mg daily Risperidone equivalents for at least 4 weeks.
Exclusion
- Female participants who are pregnant or lactating.
- Female participants with known severe abnormalities in the hypothalamo-pituitary gonadal axis, thyroid dysfunction, central nervous system tumours, history of thromboembolic disorders, severe renal failure, severe hepatic failure, cardiac disease, epilepsy or other serious medical conditions which would contraindicate estrogen use.
- Female participants already taking oral estrogen preparations containing greater then 30mcg estradiol.
- Post-menopausal or pre-menarche female participants.
- Female participants whose psychotic illness meets DSM-IV criteria for substance-induced psychotic disorder.
- Female participants who have a current diagnosis of Schizoaffective Disorder and are in a manic phase.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00357006
Start Date
July 1 2006
End Date
December 1 2013
Last Update
May 12 2015
Active Locations (1)
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1
Bayside Health - The Alfred Hospital
Melbourne, Victoria, Australia, 3181