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Clinical Estradiol Trial in Women With Schizophrenia

This study has been completed.
National Alliance for Research on Schizophrenia and Depression
Stanley Medical Research Institute
National Health and Medical Research Council, Australia
Information provided by:
Bayside Health Identifier:
First received: September 13, 2005
Last updated: February 2, 2015
Last verified: February 2015

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
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder Drug: Estradiol Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Double Blind Study of Estradiol Plus Neuroleptic Versus Placebo Plus Neuroleptic in the Treatment of Psychotic Symptoms in Women With Schizophrenia

Resource links provided by NLM:

Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • The change in psychotic symptoms as measured by Positive and Negative Symptom Scale (PANSS) over 4 week period

Secondary Outcome Measures:
  • Abnormal Involuntary Movement Scale at end of trial period
  • Adverse Symptom Checklist at end of trial period
  • Simpson Angus Scale at end of trial period
  • Hormone Measurements at end of four week period
  • Cognitive Measurements at end of trial period

Estimated Enrollment: 100
Study Start Date: January 2001
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
  Show Detailed Description


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00206570

Australia, Victoria
Bayside Health - The Alfred Hospital
Melbourne, Victoria, Australia, 3181
Sponsors and Collaborators
Bayside Health
National Alliance for Research on Schizophrenia and Depression
Stanley Medical Research Institute
National Health and Medical Research Council, Australia
Principal Investigator: Jayashri Kulkarni, MBBS, MPM, FRANZCP, PhD Bayside Health / Monash University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00206570     History of Changes
Other Study ID Numbers: APRC 75/02
Study First Received: September 13, 2005
Last Updated: February 2, 2015

Keywords provided by Bayside Health:
Gender differences

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Contraceptive Agents, Female
Pathologic Processes
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents processed this record on September 21, 2017