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Clinical Estradiol Trial in Women With Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00206570
First Posted: September 21, 2005
Last Update Posted: February 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Alliance for Research on Schizophrenia and Depression
Stanley Medical Research Institute
National Health and Medical Research Council, Australia
Information provided by:
Bayside Health
  Purpose

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

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00206570


Locations
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
Investigators
Principal Investigator: Jayashri Kulkarni, MBBS, MPM, FRANZCP, PhD Bayside Health / Monash University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00206570     History of Changes
Other Study ID Numbers: APRC 75/02
ERE-IND-INP-GRA
143654
00-105
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: February 4, 2015
Last Verified: February 2015

Keywords provided by Bayside Health:
Schizophrenia
Gender differences
Hormones
Estradiol
PANSS

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