We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Clinical Estradiol Trial in Women With Schizophrenia

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.
ClinicalTrials.gov Identifier: NCT00206570
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : February 4, 2015
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder Drug: Estradiol Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Study Start Date : January 2001
Primary Completion Date : December 2004
Study Completion Date : December 2004

Arms and Interventions

Outcome Measures

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

Secondary Outcome Measures :
  1. Abnormal Involuntary Movement Scale at end of trial period
  2. Adverse Symptom Checklist at end of trial period
  3. Simpson Angus Scale at end of trial period
  4. Hormone Measurements at end of four week period
  5. Cognitive Measurements at end of trial period

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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 ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00206570     History of Changes
Other Study ID Numbers: APRC 75/02
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 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