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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00206570




Registration number
NCT00206570
Ethics application status
Date submitted
13/09/2005
Date registered
21/09/2005
Date last updated
4/02/2015

Titles & IDs
Public title
Clinical Estradiol Trial in Women With Schizophrenia
Scientific title
Double Blind Study of Estradiol Plus Neuroleptic Versus Placebo Plus Neuroleptic in the Treatment of Psychotic Symptoms in Women With Schizophrenia
Secondary ID [1] 0 0
ERE-IND-INP-GRA
Secondary ID [2] 0 0
APRC 75/02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 0 0
Schizoaffective Disorder 0 0
Schizophreniform Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Schizophrenia
Mental Health 0 0 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The change in psychotic symptoms as measured by Positive and Negative Symptom Scale (PANSS) over 4 week period
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Abnormal Involuntary Movement Scale at end of trial period
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Adverse Symptom Checklist at end of trial period
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Simpson Angus Scale at end of trial period
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Hormone Measurements at end of four week period
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Cognitive Measurements at end of trial period
Timepoint [5] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2004
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Bayside Health - The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Alliance for Research on Schizophrenia and Depression
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Stanley Medical Research Institute
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
National Health and Medical Research Council, Australia
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00206570
Trial related presentations / publications
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. doi: 10.1001/archpsyc.65.8.955.
Public notes

Contacts
Principal investigator
Name 0 0
Jayashri Kulkarni, MBBS, MPM, FRANZCP, PhD
Address 0 0
Bayside Health / Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00206570