NCT03848234

Estradiol Patch as add-on to Antipsychotics in Patients With Schizophrenia, Schizoaffective or Schizophreniform Disorder

A Randomized Trial Administering Estradiol Patch vs. Placebo Patch as add-on to Antipsychotics in Patients With Schizophrenia, Schizoaffective or Schizophreniform Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 209 (actual)
• Sponsor: Tangent Data · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Schizophrenia
• Schizoaffective Disorder
• Schizophreniform Disorders

Interventions

Type	Name	Description
DRUG	Estradiol	2 trans dermal patches to be changed twice a week for the duration of 8 weeks.
DEVICE	Placebo	2 trans dermal patches to be changed twice a week for the duration of 8 weeks.

Timeline

• Start date: 2015-12-04
• Primary completion: 2016-07-29
• Completion: 2016-07-29
• First posted: 2019-02-20
• Last updated: 2020-05-22

Locations

1 site across 1 country: Moldova