Clinical Estradiol Trial in Women With Schizophrenia
NCT00206570 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2015-02-04
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 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.
Conditions
- Schizophrenia
- Schizoaffective Disorder
- Schizophreniform Disorder
Interventions
- DRUG
-
Estradiol
Sponsors & Collaborators
-
National Alliance for Research on Schizophrenia and Depression
collaborator OTHER -
Stanley Medical Research Institute
collaborator OTHER -
National Health and Medical Research Council, Australia
collaborator OTHER -
Bayside Health
lead OTHER_GOV
Principal Investigators
-
Jayashri Kulkarni, MBBS, MPM, FRANZCP, PhD · Bayside Health / Monash University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-01-31
- Primary Completion
- 2004-12-31
- Completion
- 2004-12-31
Countries
- Australia
Study Locations
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