Estradiol as add-on to Antipsychotics

NCT04093518 | Unknown Phase 3

• 1 other identifier: EST-S-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 or schizophreniform disorder.

Conditions

Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorders

Outcome Measures

Primary Outcomes (1)

• Change in total PANSS scores at the end of the trial

  The Positive and Negative Syndrome Scale (PANSS) is a well validated, standardized method of evaluating and monitoring psychotic symptoms. The PANSS assesses: positive (hallucinations, delusions, thought disorder), negative (blunted affect, abstract thinking and general symptomatology. The positive and negative subscale each consist of 7 items rated from 1(absent) - 7(extreme) with a minimum score = 7, maximum score = 49. The general subscale consists of 16 items with a minimum score = 16, maximum score = 112. A Total PANSS score (positive+ negative + general scores) has a minimum of 30 and maximum of 210. Higher scores represent more severity in symptoms.

  Change from Baseline at 16 weeks

Secondary Outcomes (4)

• Positive and Negative Syndrome Scale (PANSS) and general psychopathology scales

  through study, 16 weeks

• Clinical Global Impression Scale-Severity (CGI-S) and Global Impression Scale-Improvement (CGI-I),

  through study, 16 weeks

• Montgomery-Asberg Depression Rating Scale

  through study, 16 weeks

• Rates of drop outs before the end of the trial

  through study completion, an average of 1 year

Study Arms (2)

Active Comparator

ACTIVE COMPARATOR

Estradiol 200µg

Drug: Estradiol

Placebo Comparator

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Estradiol DRUG

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

Also known as: trans dermal patches

Active Comparator

Placebo DRUG

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

Also known as: trans dermal patches

Placebo Comparator

Eligibility Criteria

• Age: 38 Years - 48 Years
• Gender Eligibility Details: Gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tangent Data: lead
• Stanley Medical Research Institute: collaborator
• MediStat Ltd.: collaborator
• PCI pharma services (formerly BIOTEC SERVICES INTERNATIONAL LIMITED): collaborator
• S.C. IMUNOTEHNOMED S.R.L.: collaborator
• Tangent Data Srl: collaborator

Study Sites (1)

Centrul Comunitar de Sănătate Mintală Botanica

Chisinau, MD2072, Moldova

RECRUITING

Related Publications (17)

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MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Mark Weiser, M.D.

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paull G Radu, M.D.

CONTACT

+407 2323 4545; paull.radu@tangentdata.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Triple
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, add-on to anti-psychotics, double blind, placebo-controlled, parallel group clinical trial

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 18, 2019
• Study Start: December 2, 2019
• Primary Completion: October 15, 2020
• Study Completion: November 1, 2020
• Last Updated: May 26, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)