A Definitive Estrogen Patch Study (ADEPT)
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 women 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) P
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).
Schizophreniform Disorder(Not in Manic Phase)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline and weeks 1, 2, 4 and 8 of the trial. ] [ Designated as safety issue: No ]
- Cognitive performance (RBANS Scores) [ Time Frame: baseline and week 8 ] [ Designated as safety issue: No ]
- Scores on MADRS at trial completion [ Time Frame: Baseline and weeks 1, 2, 4 and 8 ] [ Designated as safety issue: No ]
- Scores on Adverse Symptom Checklist at trial completion [ Time Frame: Baseline and weeks 1, 2, 4, 6, 8 ] [ Designated as safety issue: Yes ]
- Change in hormone levels over trial duration [ Time Frame: Baseline and weeks 1, 4 and 8. ] [ Designated as safety issue: No ]
|Study Start Date:||July 2006|
|Estimated Study Completion Date:||December 2013|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
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
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|Bayside Health - The Alfred Hospital|
|Melbourne, Victoria, Australia, 3181|
|Principal Investigator:||Jayashri Kulkarni, MBBS, MPM, FRANZCP, PhD||Bayside Health / Monash University|