Estradiol as add-on to Antipsychotics

• Status: Unknown status
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CliniRx Tangent Research; Tangent Data
• Collaborators: MediStat Ltd.; PCI pharma services (formerly BIOTEC SERVICES INTERNATIONAL LIMITED); S.C. IMUNOTEHNOMED S.R.L.; Stanley Medical Research Institute; Tangent Data Srl
• Treatments: Antipsychotic Agents; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Polyestradiol phosphate

Criteria

Inclusion Criteria:

1. Female above 38, up to 45 years of age, inclusive

2. Willing and able to provide informed consent, after the nature of the study has been fully explained

3. Current DSM-V diagnosis of schizophrenia, schizoaffective or schizophreniform disorder as confirmed by modified SCID.

4. Total PANSS score > 70 and (PANSS positive subscale >15 and/or PANSS negative subscale >15)

5. 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.

6. Patients who are physically and endocrinologically healthy,

7. Not menopausal as assessed by asking patients if they are menstruating

8. Inpatients or outpatients. Inpatients will be randomized 3 days or more after admission

Exclusion Criteria:

1. Unwilling or unable, in the opinion of the Investigator, to comply with study instructions

2. Pregnant or breast-feeding

3. Women who are menopausal.

4. Patients treated with oral estrogen preparations containing estradiol greater than 30 mcg.

5. 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)

6. 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.

7. Likely allergy or sensitivity to estradiol.

8. Schizoaffective disorder in the manic phase.

9. At significant risk of committing suicide, or in the opinion of the Investigator, currently at imminent risk of suicide or harming others.

10. 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.

11. Concurrent delirium, mental retardation, drug-induced psychosis, or history of clinically significant brain trauma documented by CT or MRI.

12. Patients receiving phenobarbital, phenytoin, carbamazepine, rifampicin, rifabutin, nevirapine, efavirenz, ritonavir and nelfinavir,or Hypericum perforatum.