Clinical Estradiol Trial in Women With Schizophrenia

NCT00206570 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-02-04

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00206570 on ClinicalTrials.gov