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Estradiol as add-on to Antipsychotics

NCT04093518 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-05-26

No results posted yet for this study

Summary

The objective of the study is to evaluate the efficacy of Estradiol patch compared to placebo, as add-on to anti-psychotics in the treatment of women 38 and older with schizophrenia, schizoaffective or schizophreniform disorder.

Conditions

  • Schizophrenia
  • Schizoaffective Disorder
  • Schizophreniform Disorders

Interventions

DRUG

Estradiol

2 transdermal patches to be changed twice a week for the duration of 16 weeks

DRUG

Placebo

2 transdermal patches to be changed twice a week for the duration of 16 weeks

Sponsors & Collaborators

  • Stanley Medical Research Institute

    collaborator OTHER

  • MediStat Ltd.

    collaborator UNKNOWN

  • PCI pharma services (formerly BIOTEC SERVICES INTERNATIONAL LIMITED)

    collaborator UNKNOWN

  • S.C. IMUNOTEHNOMED S.R.L.

    collaborator UNKNOWN

  • Tangent Data Srl

    collaborator UNKNOWN

  • Tangent Data

    lead OTHER

Principal Investigators

  • Mark Weiser, M.D. · Sheba Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
38 Years
Max Age
48 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-02
Primary Completion
2020-10-15
Completion
2020-11-01

Countries

  • Moldova

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04093518 on ClinicalTrials.gov