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).