Schizophrenia Clinical Trial
Official title:
A Randomized Trial Administering Estradiol Patch vs. Placebo Patch as add-on to Antipsychotics in Patients With Schizophrenia, Schizoaffective or Schizophreniform Disorder
To evaluate the effects of Estradiol patches vs placebo patches as add-on to antipsychotics on psychometric performance in patients with schizophrenia, schizoaffective or schizophreniform disorder
Estradiol has been shown to be an effective adjunctive treatment for schizophrenia. The
estradiol hypothesis was tested in a randomized-controlled trial in which estradiol was given
to women with schizophrenia, schizoaffective or schizophreniform disorder aged 18 to 45 -
Kulkarni 2014. In that 3 arms trial, Kulkarni administered transdermal 100 µg estradiol/200
µg estradiol/ placebo to patients receiving anti-psychotics and reported reductions in PANSS
positive, general and total symptoms in both estradiol patients' groups compared with the
placebo group. Patients receiving 200 µg experienced greater improvement, specifically in the
PANSS positive subscale, the effect size was 0.44.
The objective of this study is to attempt to confirm Kulkarni's trial in a large-scale trial.
This proposed study is a 2-arm study, in which patients will be randomized to either 200 µg
estradiol or placebo in order to test the effectiveness of estradiol on women of childbearing
age with schizophrenia, schizoaffective or schizophreniform disorder for a limited period of
56 days.
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