Clinical Estradiol Trial in Women With Schizophrenia

This study is currently recruiting participants.

Verified by Bayside Health, September 2005

First Received: September 13, 2005 Last Updated: February 16, 2007 History of Changes

Sponsors and Collaborators:	Bayside Health National Alliance for Research on Schizophrenia and Depression Stanley Medical Research Institute National Health and Medical Research Council, Australia
Information provided by:	Bayside Health
ClinicalTrials.gov Identifier:	NCT00206570

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 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

Resource links provided by NLM:

MedlinePlus related topics: Psychotic Disorders Schizophrenia

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

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 2002
Estimated Study Completion Date:	December 2005

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206570

Contacts

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

Locations

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)

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

Additional Information:

Alfred Psychiatry Research Centre This link exits the ClinicalTrials.gov site

No publications provided by Bayside Health

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Kulkarni J, de Castella A, Fitzgerald PB, Gurvich CT, Bailey M, Bartholomeusz C, Burger H. Estrogen in severe mental illness: a potential new treatment approach. Arch Gen Psychiatry. 2008 Aug;65(8):955-60.

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 History of Changes
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by Bayside Health:

Schizophrenia
Gender differences
Hormones
Estradiol
PANSS

Study placed in the following topic categories:

Estrogens
Contraceptive Agents
Benzoates
Hormone Antagonists
Estradiol valerate
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Estradiol 17 beta-cypionate
Antipsychotic Agents

Hormones
Estradiol
Schizophrenia
Mental Disorders
Estradiol 3-benzoate
Psychotic Disorders
Polyestradiol phosphate
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Estrogens
Disease
Contraceptive Agents
Physiological Effects of Drugs
Estradiol valerate
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Estradiol 17 beta-cypionate
Hormones

Pharmacologic Actions
Estradiol
Schizophrenia
Pathologic Processes
Mental Disorders
Therapeutic Uses
Estradiol 3-benzoate
Psychotic Disorders
Polyestradiol phosphate
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on July 02, 2009