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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
209
Clinical Psychiatric Hospital
Codru, Chișinău Municipality, Moldova
PANSS positive subscale at the end of the trial
To evaluate the effects of Estradiol on Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Time frame: 8 weeks
PANSS total, negative and general psychopathology scales
To evaluate the effects of Estradiol on Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Time frame: 8 weeks
Clinical Global Impression Scale-Severity (CGI-S) and Global Impression Scale-Improvement (CGI-I)
To evaluate the effects of Estradiol on Clinical Global Impression
Time frame: 8 weeks
Brief Assessment of Cognition in Schizophrenia (BACS),
To evaluate the effects of Estradiol on cognition
Time frame: 8 weeks
Montgomery-Asberg Depression Rating Scale
To evaluate the effects of Estradiol on depressive symptoms
Time frame: 8 weeks
Rates of drop outs before the end of the trial
To evaluate the rate of drop outs
Time frame: through study completion, an average of 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.