SchizophreniaPhase 3NCT03848234
Estradiol Patch as add-on to Antipsychotics in Patients With Schizophrenia, Schizoaffective or Schizophreniform Disorder
A Phase 3 study testing Estradiol in people with Schizophrenia and Schizoaffective Disorder, run by Tangent Data at 1 site in Moldova.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders
- What is being tested?
- Estradiol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 209 participants
- Where
- 1 siteMoldova
- Study dates
- 4 Dec 2015to 29 Jul 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Moldova1 site
Clinical Psychiatric Hospital
Codru, Chișinău Municipality, 2011
About this study
Official title: A Randomized Trial Administering Estradiol Patch vs. Placebo Patch as add-on to Antipsychotics in Patients With Schizophrenia, Schizoaffective or Schizophreniform Disorder
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
Read the 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.
- Being tested
- Estradiol, Placebo
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstradiolDrug
Also called trans dermal patches
2 trans dermal patches to be changed twice a week for the duration of 8 weeks.
PlaceboDevice
Also called trans dermal patches
2 trans dermal patches to be changed twice a week for the duration of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A Estradiol | Experimental | 2 trans dermal patches to be changed twice a week for the duration of 8 weeks Receives: Drug: Estradiol; Device: Placebo |
| B Placebo | Placebo comparator | 2 trans dermal patches to be changed twice a week for the duration of 8 weeks Receives: Drug: Estradiol; Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PANSS positive subscale at the end of the trial
To evaluate the effects of Estradiol on Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Measured: 8 weeks
Secondary outcomes (5)
PANSS total, negative and general psychopathology scales
To evaluate the effects of Estradiol on Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Measured: 8 weeks
Clinical Global Impression Scale-Severity (CGI-S) and Global Impression Scale-Improvement (CGI-I)
To evaluate the effects of Estradiol on Clinical Global Impression
Measured: 8 weeks
Brief Assessment of Cognition in Schizophrenia (BACS),
To evaluate the effects of Estradiol on cognition
Measured: 8 weeks
Montgomery-Asberg Depression Rating Scale
To evaluate the effects of Estradiol on depressive symptoms
Measured: 8 weeks
Rates of drop outs before the end of the trial
To evaluate the rate of drop outs
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start4 Dec 2015
- Primary completion29 Jul 2016
- Study completion29 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, add-on to anti-psychotics, double blind, placebo-controlled, parallel group clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tangent Data
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Paull G Radu, M.D., Study director, Tangent Data
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848234
- Sponsor's protocol ID
- EST-S-01
- Status last verified
- Feb 2019
- First submitted
- 13 Feb 2019
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31365044
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Administering Estradiol Patch vs. Placebo Patch as add-on to Antipsychotics in Patients With Schizophrenia, Schizoaffective or Schizophreniform Disorder
- ClinicalTrials.gov ID
- NCT03848234
- Acronym / sponsor ID
- EST-S-01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Tangent DataUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Study start
- 4 Dec 2015 (actual)
- Primary completion
- 29 Jul 2016 (actual)
- Study completion
- 29 Jul 2016 (actual)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, add-on to anti-psychotics, double blind, placebo-controlled, parallel group clinical trial
| Arm | Type | Receives |
|---|---|---|
| A Estradiol | Experimental | Drug: Estradiol, Device: Placebo2 trans dermal patches to be changed twice a week for the duration of 8 weeks |
| B Placebo | Placebo comparator | Drug: Estradiol, Device: Placebo2 trans dermal patches to be changed twice a week for the duration of 8 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EstradiolAlso: trans dermal patches2 trans dermal patches to be changed twice a week for the duration of 8 weeks. | Drug | A Estradiol, B Placebo |
| PlaceboAlso: trans dermal patches2 trans dermal patches to be changed twice a week for the duration of 8 weeks. | Device | A Estradiol, B Placebo |
Primary outcome
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)
5 secondary outcomes
PANSS total, negative and general psychopathology scales
Time frame: 8 weeks
Clinical Global Impression Scale-Severity (CGI-S) and Global Impression Scale-Improvement (CGI-I)
Time frame: 8 weeks
Brief Assessment of Cognition in Schizophrenia (BACS),
Time frame: 8 weeks
Montgomery-Asberg Depression Rating Scale
Time frame: 8 weeks
Rates of drop outs before the end of the trial
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
- Derived from this study: PubMed 31365044Weiser 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.
- Individual participant dataSharing planned: Undecided
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paull G Radu, M.D. study director
Tangent Data
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Estradiol in people with Schizophrenia and Schizoaffective Disorder, run by Tangent Data at 1 site in Moldova.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PANSS positive subscale at the end of the trial (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03848234, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2020.