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

NCT03848234 | Completed Phase 3

• 1 other identifier: EST-S-01
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorders

Outcome Measures

Primary Outcomes (1)

• PANSS positive subscale at the end of the trial

  To evaluate the effects of Estradiol on Positive and Negative Syndrome Scale for Schizophrenia (PANSS)

  8 weeks

Secondary Outcomes (5)

• PANSS total, negative and general psychopathology scales

  8 weeks

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

  8 weeks

• Brief Assessment of Cognition in Schizophrenia (BACS),

  8 weeks

• Montgomery-Asberg Depression Rating Scale

  8 weeks

• Rates of drop outs before the end of the trial

  through study completion, an average of 1 year

Study Arms (2)

A Estradiol

EXPERIMENTAL

2 trans dermal patches to be changed twice a week for the duration of 8 weeks

Drug: Estradiol; Device: Placebo

B Placebo

PLACEBO COMPARATOR

2 trans dermal patches to be changed twice a week for the duration of 8 weeks

Drug: Estradiol; Device: Placebo

Interventions

Estradiol DRUG

2 trans dermal patches to be changed twice a week for the duration of 8 weeks.

Also known as: trans dermal patches

A Estradiol; B Placebo

Placebo DEVICE

2 trans dermal patches to be changed twice a week for the duration of 8 weeks.

Also known as: trans dermal patches

A Estradiol; B Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female, 18-45 years of age, inclusive
• Willing and able to provide informed consent, after the nature of the study has been fully explained
• Current DSM-IV-TR diagnosis of schizophrenia, schizoaffective or schizophreniform disorder as confirmed by modified SCID.
• Total PANSS score \> 60 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 insure 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,
• 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, vaginal bleeding between periods, untreated endometrial hyperplasia, previous or present thrombembolism, known thrombophilic disorders, abnormal liver function tests, porphyria.
• History of 1st and 2nd grade family with breast or uterine cancer,
• 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 is at imminent risk of suicide or harming others.
• Patients with a current DSM-IV 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

Study Sites (1)

Clinical Psychiatric Hospital

Codru, Chișinău Municipality, 2011, Moldova

Location

Related Publications (1)

• Weiser M, Levi L, Zamora D, Biegon A, SanGiovanni JP, Davidson M, Burshtein S, Gonen I, Radu P, Slobozean Pavalache K, Nastas I, Hemi R, Ryan T, Davis JM. Effect of Adjunctive Estradiol on Schizophrenia Among Women of Childbearing Age: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Oct 1;76(10):1009-1017. doi: 10.1001/jamapsychiatry.2019.1842.

  PMID: 31365044 DERIVED

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

• Paull G Radu, M.D.

  Tangent Data

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• 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: February 13, 2019
• First Posted: February 20, 2019
• Study Start: December 4, 2015
• Primary Completion: July 29, 2016
• Study Completion: July 29, 2016
• Last Updated: May 22, 2020

Record last verified: 2019-02

Locations

MO (1)