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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]

05T-742

Secondary ID [2]

202/04

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Schizophrenia

Schizoaffective Disorder

Schizophreniform Disorder(Not in Manic Phase)

Condition category

Condition code

Mental Health

Schizophrenia

Mental Health

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]

Treatment: Drugs

Intervention code [2]

Other interventions

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Positive and Negative Syndrome Scale (PANSS)

Timepoint [1]

Baseline and week 8

Secondary outcome [1]

Cognitive Performance (RBANS Scores)

Timepoint [1]

baseline and week 8

Secondary outcome [2]

Scores on MADRS at Trial Completion

Timepoint [2]

Baseline and week 8

Secondary outcome [3]

Scores on Adverse Symptom Checklist at Trial Completion

Timepoint [3]

Baseline and weeks 1, 2, 4, 6, 8

Secondary outcome [4]

Change in Hormone Levels Over Trial Duration

Timepoint [4]

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?

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]

Bayside Health - The Alfred Hospital - Melbourne

Recruitment postcode(s) [1]

3181 - Melbourne

Funding & Sponsors

Primary sponsor type

Other

Name

The Alfred

Address

Country

Other collaborator category [1]

Other

Name [1]

Stanley Medical Research Institute

Address [1]

Country [1]

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

Jayashri Kulkarni, MBBS, MPM, FRANZCP, PhD

Address

Bayside Health / Monash University

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00357006

Trial Review

Registering a new trial?

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