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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00357006




Registration number
NCT00357006
Ethics application status
Date submitted
26/07/2006
Date registered
27/07/2006
Date last updated
12/05/2015

Titles & IDs
Public title
A Definitive Estrogen Patch Study (ADEPT)
Scientific title
Multisite Double-Blind Randomized Controlled Study of Estradiol Plus Antipsychotic Versus Placebo Plus Antipsychotic in the Treatment of Psychotic Symptoms in Women With Schizophrenia
Secondary ID [1] 0 0
05T-742
Secondary ID [2] 0 0
202/04
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(Not in Manic Phase) 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
Treatment: Drugs - Estradiol
Treatment: Drugs - Estradiol
Other interventions - placebo

Active comparator: 1 - 100 mcg Estradiol

Active comparator: 2 - 200 mcg Estradiol

Placebo comparator: 3 - adjunctive transdermal placebo


Treatment: Drugs: Estradiol
100 mcg adjunctive transdermal estradiol

Treatment: Drugs: Estradiol
200 mcg adjunctive transdermal estradiol

Other interventions: placebo
adjunctive transdermal placebo
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Positive and Negative Syndrome Scale (PANSS)
Timepoint [1] 0 0
Baseline and week 8
Secondary outcome [1] 0 0
Cognitive Performance (RBANS Scores)
Timepoint [1] 0 0
baseline and week 8
Secondary outcome [2] 0 0
Scores on MADRS at Trial Completion
Timepoint [2] 0 0
Baseline and week 8
Secondary outcome [3] 0 0
Scores on Adverse Symptom Checklist at Trial Completion
Timepoint [3] 0 0
Baseline and weeks 1, 2, 4, 6, 8
Secondary outcome [4] 0 0
Change in Hormone Levels Over Trial Duration
Timepoint [4] 0 0
Baseline and weeks 1, 4 and 8.

Eligibility
Key inclusion criteria
* Female participants of potential child-bearing age (Pre-menopausal and Post-menarche)
* Female participants who meet the MINI (Mini International Neuropsychiatric Interview for DSM-IV) diagnostic criteria for current psychotic disorder or have a current DSM-IV diagnosis of Schizophrenia, Schizophreniform Disorder, or Schizoaffective Disorder (not in manic phase).
* Female participants with a PANSS positive score greater than 15 and/or a PANSS negative score greater than 15.
* Female participants who are able to give informed consent
* Female participants receiving 2-20mg daily Risperidone equivalents for at least 4 weeks.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Female participants who are pregnant or lactating.
* Female participants with known severe abnormalities in the hypothalamo-pituitary gonadal axis, thyroid dysfunction, central nervous system tumours, history of thromboembolic disorders, severe renal failure, severe hepatic failure, cardiac disease, epilepsy or other serious medical conditions which would contraindicate estrogen use.
* Female participants already taking oral estrogen preparations containing greater then 30mcg estradiol.
* Post-menopausal or pre-menarche female participants.
* Female participants whose psychotic illness meets DSM-IV criteria for substance-induced psychotic disorder.
* Female participants who have a current diagnosis of Schizoaffective Disorder and are in a manic phase.

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?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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
1/07/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2013
Sample size
Target
Accrual to date
Final
180
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
Other
Name
The Alfred
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Stanley Medical Research Institute
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
OBJECTIVE:

To test the use of adjunctive estrogen in a 8 week, three-arm, double-blind, placebo-controlled study in the treatment of psychotic symptoms in women with schizophrenia.

HYPOTHESIS:

That women receiving adjunctive estrogen will demonstrate significantly greater improvements in the symptoms of schizophrenia than women receiving adjunctive placebo.

STUDY POPULATION:

180 women will be recruited over a three-year period across three sites. Participant will be of potential child-bearing age (Pre-menopausal and Post-menarche) with a current diagnosis of Schizophrenia, Schizophreniform Disorder, or Schizoaffective Disorder (not in manic phase)according to the Mini International Neuropsychiatric Interview (MINI).

STUDY MEDICATION:

Estradiol. One third of the participants (n=60) will be randomised to receive adjunctive 100mcg Estradiol; one third of the participants (n=60) will be randomised to receive adjunctive 200mcg Estradiol n=60; and, one third of the participants (n=60) will be randomised to receive adjunctive placebo n=60). All patches will be covered with identical adhesive contact to ensure the "blind" is maintained.

STUDY EVALUATIONS:

Data will be collected over a two-month period for each participant. Visits will be performed at baseline, and then at weekly or fortnightly intervals. A total of six visits will be completed for each participant. The following evaluations will be performed:

i) Inclusion/exclusion checklist. (Baseline visit only)

ii) Informed consent. (Baseline visit only)

iii)psychiatric evaluation to determine diagnosis. (Baseline visit only)

iv) General clinical evaluation including medical history, current conditions and a non-invasive physical examination, body weight, vital signs. (Baseline and endpoint visits)

v) Medication history. (Baseline and evaluation visits)

vi) Demographics. (Baseline visits only)

vii) The primary outcome measures will be the Positive and Negative Syndrome Scale (PANSS), which will be taken at weeks 1, 2, 4 and 8 of the trial. Cognitive testing will take place at baseline and 8 weeks. Side effects will be assessed at weeks 1, 2, 4, 6, and 8 to measure changes in subject's reported side effects during the trial.

viii) Laboratory tests including; Serum levels of mood stabiliser, LH, FSH, Estrogen, Progesterone, Prolactin, DHEA,Testosterone and(Baseline and evaluation visits).
Trial website
https://clinicaltrials.gov/study/NCT00357006
Trial related presentations / publications
Thomas N, Gurvich C, Hudaib AR, Gavrilidis E, de Castella RA, Thomas EH, Kulkarni J. Serum estradiol as a blood-based biomarker predicting hormonal treatment outcomes in women with schizophrenia. Psychoneuroendocrinology. 2021 Apr;126:105165. doi: 10.1016/j.psyneuen.2021.105165. Epub 2021 Feb 10.
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/NCT00357006