Status:
UNKNOWN
Estradiol as add-on to Antipsychotics
Lead Sponsor:
Tangent Data
Collaborating Sponsors:
Stanley Medical Research Institute
MediStat Ltd.
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
FEMALE
38-48 years
Phase:
PHASE3
Brief 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 o...
Detailed Description
Several lines of evidence suggest that estrogen affects the course of schizophrenia. The onset of schizophrenia is 2-4 years later in women than in men, and women have a lower incidence of schizophren...
Eligibility Criteria
Inclusion
- Female above 38, up to 45 years of age, inclusive
- Willing and able to provide informed consent, after the nature of the study has been fully explained
- Current DSM-V diagnosis of schizophrenia, schizoaffective or schizophreniform disorder as confirmed by modified SCID.
- Total PANSS score \> 70 and (PANSS positive subscale \>15 and/or PANSS negative subscale \>15)
- Must be on a stable dose of any antipsychotic drug, for at least 2 weeks prior to the baseline visit, at doses within the PORT criteria, whenever possible. Patients receiving higher doses will have their records reviewed to ensure that their dose is required and, if possible, will be stabilized on a lower dose prior to study entry.
- Patients who are physically and endocrinologically healthy,
- Not menopausal as assessed by asking patients if they are menstruating
- Inpatients or outpatients. Inpatients will be randomized 3 days or more after admission
Exclusion
- Unwilling or unable, in the opinion of the Investigator, to comply with study instructions
- Pregnant or breast-feeding
- Women who are menopausal.
- Patients treated with oral estrogen preparations containing estradiol greater than 30 mcg.
- Women who have known severe abnormalities in the hypothalamo-pituitary gonadal axis, thyroid disorders, severe medical conditions and disorders that would contraindicate estrogen use (breast cancer, migraine with aura or stroke)
- History of endometrial cancer or breast cancer, history of breast or uterine cancer, no history of 1st and 2nd grade family with breast or uterine cancer, vaginal bleeding between periods.
- Likely allergy or sensitivity to estradiol.
- Schizoaffective disorder in the manic phase.
- At significant risk of committing suicide, or in the opinion of the Investigator, currently at imminent risk of suicide or harming others.
- Patients with a current DSM-V substance or alcohol abuse. Patients with a history of and/or current recreational use of cannabinoids or alcohol, and/or patients who smoke cigarettes can be included.
- Concurrent delirium, mental retardation, drug-induced psychosis, or history of clinically significant brain trauma documented by CT or MRI.
- Patients receiving phenobarbital, phenytoin, carbamazepine, rifampicin, rifabutin, nevirapine, efavirenz, ritonavir and nelfinavir,or Hypericum perforatum.
Key Trial Info
Start Date :
December 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04093518
Start Date
December 2 2019
End Date
November 1 2020
Last Update
May 26 2020
Active Locations (1)
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1
Centrul Comunitar de Sănătate Mintală Botanica
Chisinau, Moldova, MD2072