A Definitive Estrogen Patch Study (ADEPT)
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|ClinicalTrials.gov Identifier: NCT00357006|
Recruitment Status : Completed
First Posted : July 27, 2006
Results First Posted : April 1, 2015
Last Update Posted : May 12, 2015
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.
That women receiving adjunctive estrogen will demonstrate significantly greater improvements in the symptoms of schizophrenia than women receiving adjunctive placebo.
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).
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.
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).
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder Schizophreniform Disorder(Not in Manic Phase)||Drug: Estradiol Other: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official 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|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||December 2013|
Active Comparator: 1
100 mcg Estradiol
100 mcg adjunctive transdermal estradiol
Active Comparator: 2
200 mcg Estradiol
200 mcg adjunctive transdermal estradiol
Placebo Comparator: 3
adjunctive transdermal placebo
adjunctive transdermal placebo
- Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline and week 8 ]The Positive and Negative Syndrome Scale (PANSS) is a well validated, standardized method of evaluating and monitoring psychotic symptoms. The PANSS assesses: positive (hallucinations, delusions, thought disorder), negative (blunted affect, abstract thinking and general symptomatology. The positive and negative subscale each consist of 7 items rated from 1(absent) - 7(extreme) with a minimum score = 7, maximum score = 49. The general subscale consists of 16 items with a minimum score = 16, maximum score = 112. A Total PANSS score (positive+ negative + general scores) has a minimum of 30 and maximum of 210. Higher scores represent more severity in symptoms.
- Cognitive Performance (RBANS Scores) [ Time Frame: baseline and week 8 ]
- Scores on MADRS at Trial Completion [ Time Frame: Baseline and week 8 ]
- Scores on Adverse Symptom Checklist at Trial Completion [ Time Frame: Baseline and weeks 1, 2, 4, 6, 8 ]
- Change in Hormone Levels Over Trial Duration [ Time Frame: Baseline and weeks 1, 4 and 8. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00357006
|Bayside Health - The Alfred Hospital|
|Melbourne, Victoria, Australia, 3181|
|Principal Investigator:||Jayashri Kulkarni, MBBS, MPM, FRANZCP, PhD||Bayside Health / Monash University|