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Sponsors and Collaborators: |
Bayside Health National Alliance for Research on Schizophrenia and Depression Stanley Medical Research Institute National Health and Medical Research Council, Australia |
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Information provided by: | Bayside Health |
ClinicalTrials.gov Identifier: | NCT00206570 |
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 matched group receiving standard antipsychotic drug treatment plus 100microgram estradiol patch in a double blind controlled trial.
Hypothesis : That the women receiving adjunctive estradiol will demonstrate a more rapid and more substantial decrease in psychotic symptoms over the course of the study than the women receiving adjunctive placebo.
Condition | Intervention | Phase |
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Schizophrenia Schizoaffective Disorder Schizophreniform Disorder |
Drug: Estradiol |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Double Blind Study of Estradiol Plus Neuroleptic Versus Placebo Plus Neuroleptic in the Treatment of Psychotic Symptoms in Women With Schizophrenia |
Estimated Enrollment: | 100 |
Study Start Date: | January 2002 |
Estimated Study Completion Date: | December 2005 |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jayashri Kulkarni, MBBS, MPM, FRANZCP, PhD | +61 3 9276 6564 ext 6564 | j.kulkarni@alfred.org.au |
Contact: Anthony de Castella, Dip App Sci, B.A, M.A | +61 3 9276 6564 ext 6564 | a.decastella@alfred.org.au |
Australia, Victoria | |
Bayside Health - The Alfred Hospital | Recruiting |
Melbourne, Victoria, Australia, 3181 | |
Contact: Anthony de Castella, Dip.App.Sci., B.A., M.A. +61 3 9276 6564 ext 6564 a.decastella@alfred.org.au | |
Contact: Suzette Sheppard, B Sc (Hons) +61 3 9276 6564 ext 6564 S.Sheppard@alfred.org.au | |
Sub-Investigator: Anthony R de Castella, Dip.App.Sci., B.A., M.A. | |
Sub-Investigator: Paul B Fitzgerald, MBBS, MPM, FRANZCP, PhD | |
Sub-Investigator: Suzette J Sheppard, B Sc (Hons) |
Principal Investigator: | Jayashri Kulkarni, MBBS, MPM, FRANZCP, PhD | Bayside Health / Monash University |
Study ID Numbers: | APRC 75/02, ERE-IND-INP-GRA, 143654, 00-105 |
Study First Received: | September 13, 2005 |
Last Updated: | February 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00206570 |
Health Authority: | Australia: Human Research Ethics Committee |
Schizophrenia Gender differences Hormones Estradiol PANSS |
Schizophrenia Benzoates Mental Disorders Estradiol 3-benzoate Estradiol valerate |
Psychotic Disorders Estradiol 17 beta-cypionate Polyestradiol phosphate Estradiol Schizophrenia and Disorders with Psychotic Features |
Estrogens Pathologic Processes Disease Contraceptive Agents Therapeutic Uses Physiological Effects of Drugs |
Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Hormones Pharmacologic Actions |