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Trial record 23 of 2076 for:    ESTRADIOL

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

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ClinicalTrials.gov Identifier: NCT03848234
Recruitment Status : Completed
First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
CliniRx Tangent Research

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

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Schizophreniform Disorders Drug: Estradiol Device: Placebo Phase 3

Detailed Description:

Estradiol has been shown to be an effective adjunctive treatment for schizophrenia. The estradiol hypothesis was tested in a randomized-controlled trial in which estradiol was given to women with schizophrenia, schizoaffective or schizophreniform disorder aged 18 to 45 - Kulkarni 2014. In that 3 arms trial, Kulkarni administered transdermal 100 µg estradiol/200 µg estradiol/ placebo to patients receiving anti-psychotics and reported reductions in PANSS positive, general and total symptoms in both estradiol patients' groups compared with the placebo group. Patients receiving 200 µg experienced greater improvement, specifically in the PANSS positive subscale, the effect size was 0.44.

The objective of this study is to attempt to confirm Kulkarni's trial in a large-scale trial. This proposed study is a 2-arm study, in which patients will be randomized to either 200 µg estradiol or placebo in order to test the effectiveness of estradiol on women of childbearing age with schizophrenia, schizoaffective or schizophreniform disorder for a limited period of 56 days.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 209 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, add-on to anti-psychotics, double blind, placebo-controlled, parallel group clinical trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Trial Administering Estradiol Patch vs. Placebo Patch as add-on to Antipsychotics in Patients With Schizophrenia, Schizoaffective or Schizophreniform Disorder
Actual Study Start Date : December 4, 2015
Actual Primary Completion Date : July 29, 2016
Actual Study Completion Date : July 29, 2016


Arm Intervention/treatment
Experimental: A Estradiol
2 trans dermal patches to be changed twice a week for the duration of 8 weeks
Drug: Estradiol
2 trans dermal patches to be changed twice a week for the duration of 8 weeks.
Other Name: trans dermal patches

Device: Placebo
2 trans dermal patches to be changed twice a week for the duration of 8 weeks.
Other Name: trans dermal patches

Placebo Comparator: B Placebo
2 trans dermal patches to be changed twice a week for the duration of 8 weeks
Drug: Estradiol
2 trans dermal patches to be changed twice a week for the duration of 8 weeks.
Other Name: trans dermal patches

Device: Placebo
2 trans dermal patches to be changed twice a week for the duration of 8 weeks.
Other Name: trans dermal patches




Primary Outcome Measures :
  1. PANSS positive subscale at the end of the trial [ Time Frame: 8 weeks ]
    To evaluate the effects of Estradiol on Positive and Negative Syndrome Scale for Schizophrenia (PANSS)


Secondary Outcome Measures :
  1. PANSS total, negative and general psychopathology scales [ Time Frame: 8 weeks ]
    To evaluate the effects of Estradiol on Positive and Negative Syndrome Scale for Schizophrenia (PANSS)

  2. Clinical Global Impression Scale-Severity (CGI-S) and Global Impression Scale-Improvement (CGI-I) [ Time Frame: 8 weeks ]
    To evaluate the effects of Estradiol on Clinical Global Impression

  3. Brief Assessment of Cognition in Schizophrenia (BACS), [ Time Frame: 8 weeks ]
    To evaluate the effects of Estradiol on cognition

  4. Montgomery-Asberg Depression Rating Scale [ Time Frame: 8 weeks ]
    To evaluate the effects of Estradiol on depressive symptoms

  5. Rates of drop outs before the end of the trial [ Time Frame: through study completion, an average of 1 year ]
    To evaluate the rate of drop outs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female, 18-45 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-IV-TR diagnosis of schizophrenia, schizoaffective or schizophreniform disorder as confirmed by modified SCID.
  4. Total PANSS score > 60 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 insure 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. 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, vaginal bleeding between periods, untreated endometrial hyperplasia, previous or present thrombembolism, known thrombophilic disorders, abnormal liver function tests, porphyria.
  7. History of 1st and 2nd grade family with breast or uterine cancer,
  8. Likely allergy or sensitivity to estradiol.
  9. Schizoaffective disorder in the manic phase.
  10. At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others.
  11. 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.
  12. Concurrent delirium, mental retardation, drug-induced psychosis, or history of clinically significant brain trauma documented by CT or MRI.
  13. Patients receiving phenobarbital, phenytoin, carbamazepine, rifampicin, rifabutin, nevirapine, efavirenz, ritonavir and nelfinavir,or Hypericum perforatum

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848234


Locations
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Moldova, Republic of
Clinical Psychiatric Hospital
Codru, Chisinau, Moldova, Republic of, 2011
Sponsors and Collaborators
CliniRx Tangent Research
Stanley Medical Research Institute
Investigators
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Study Director: Paull G Radu, M.D. Tangent Data

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: CliniRx Tangent Research
ClinicalTrials.gov Identifier: NCT03848234     History of Changes
Other Study ID Numbers: EST-S-01
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Disease
Schizophrenia
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs