SchizophreniaPhase 2NCT03817528

ITI-007 (Lumateperone Tosylate) for Schizophrenia

A Phase 2 study testing ITI-007 in people with Schizophrenia, run by New York State Psychiatric Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The purpose of this study is to offer open label ITI-007 treatment to patients who poorly respond or poorly tolerate approved medications. Read more about this study

Who is it for?: Ages 18 to 60 years, men only
Conditions the study is for: Schizophrenia
What is being tested?: ITI-007
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2019to 23 Sep 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 years
Men only
No healthy volunteers
Adult

Who may be able to join

Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder
Has capacity to provide informed consent
Medically stable for study participation
Judged clinically not to be at significant suicide or violence risk
Inadequate response or tolerability to previously antipsychotic therapy, as defined by at least one of the following: prior clozapine failure, a PANSS>80 despite at least six weeks of a current antipsychotic therapy, a Clinical Global Impressions scale-Improvement (CGI-I) of 4 after at least two six week trials of antipsychotics (retrospective assessment) or failure to tolerate an adequate dose of at least antipsychotics (as defined by the Physicians Desk Reference)

Who cannot join

Substance abuse within last 90 days
ECG abnormality that is clinically significant
Pregnancy, lactation, or lack of use of effective birth control
Presence or positive history of significant unstable medical or neurological illness (including any history of seizure disorder, hepatitis, renal insufficiency or mental retardation), history of HIV
Clinically significant abnormal laboratory tests, positive for hepatitis B or C or liver function tests (LFTs) > 2x Upper Limit of Normal, use of strong CYP3A4 inhibitors or inducers
History or presence of concomitant major psychiatric illness.
Use of other antipsychotic medications at baseline.
Use of another investigational medication in the previous 4 weeks

Trial locations and contacts

1 site in 1 country.

United States1 site

New York State Psychiatric Institute
New York, New York, 10032

Other trials in United States

About this study

The purpose of this study is to offer open label ITI-007 treatment to patients who poorly respond or poorly tolerate approved medications.

Read the detailed description

Patients will be started on ITI-007 and current medication will be slowly discontinued within the first 7 days of starting ITI-007, with some flexibility allowed if clinically indicated. No patients will be left unmedicated because of this study.

Patients will be seen weekly for the first 4 weeks, biweekly for the second month and then monthly for six months. Patients will be monitored by clinical and safety rating scales, and will be required to show improvement after 3 months to remain in this study. Patients not improving at this time will be assessed for the risks/benefits of continuing.

Conditions: Schizophrenia
Being tested: ITI-007
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ITI-007Drug
Also called Lumateperone tosylate
ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events

Study groups in NCT03817528
Study group	Role	What they receive
ITI-007	Experimental	Open-Label ITI-007 40-60 mg Receives: Drug: ITI-007

What is being measured

The primary outcome is the main question the study is designed to answer.

Schizophrenia Symptoms
schizophrenia symptoms will be measures using the Positive and Negative Symptom Scale (PANSS) Total PANSS score (range: 30-210). Individual items scored from 1(absent) to 7 (extremely severe). Total PANSS score is sum of the 30 individual items with lowest score (30) indicating all symptoms absent and the maximum score (210) indicating all symptoms rated as extremely severe.
Measured: Change from baseline in Total PANSS score after 6 month treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 201923 Sep 2020

First posted25 Jan 2019
Study start1 Mar 2019
Primary completion23 Sep 2020
Study completion23 Sep 2020

Why it stopped: ITI-007 approved by FDA

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: open-label
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03817528
Sponsor's protocol ID: 7716
Status last verified: Nov 2021
First submitted: 30 Nov 2018
Last updated: 4 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ITI-007 (Lumateperone Tosylate) for Schizophrenia
ClinicalTrials.gov ID: NCT03817528
Acronym / sponsor ID: 7716
Conditions: Schizophrenia
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: ITI-007 approved by FDA
Enrolment: 4 participants (actual)
Lead sponsor: New York State Psychiatric InstituteUniversity, hospital or other
Collaborators: Intra-Cellular Therapies, Inc.
Study start: 1 Mar 2019 (actual)
Primary completion: 23 Sep 2020 (actual)
Study completion: 23 Sep 2020 (actual)
First posted: 25 Jan 2019 (actual)
Results: Posted 2 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to offer open label ITI-007 treatment to patients who poorly respond or poorly tolerate approved medications.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: open-label

Arm	Type	Receives
ITI-007	Experimental	Drug: ITI-007Open-Label ITI-007 40-60 mg

Who may qualify

Ages: 18 to 60 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder
Has capacity to provide informed consent
Medically stable for study participation
Judged clinically not to be at significant suicide or violence risk
Inadequate response or tolerability to previously antipsychotic therapy, as defined by at least one of the following: prior clozapine failure, a PANSS>80 despite at least six weeks of a current antipsychotic therapy, a Clinical Global Impressions scale-Improvement (CGI-I) of 4 after at least two six week trials of antipsychotics (retrospective assessment) or failure to tolerate an adequate dose of at least antipsychotics (as defined by the Physicians Desk Reference)

Key exclusion criteria (8 listed)

Substance abuse within last 90 days
ECG abnormality that is clinically significant
Pregnancy, lactation, or lack of use of effective birth control
Presence or positive history of significant unstable medical or neurological illness (including any history of seizure disorder, hepatitis, renal insufficiency or mental retardation), history of HIV
Clinically significant abnormal laboratory tests, positive for hepatitis B or C or liver function tests (LFTs) > 2x Upper Limit of Normal, use of strong CYP3A4 inhibitors or inducers

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
ITI-007Also: Lumateperone tosylateITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events	Drug	ITI-007

Primary outcome

Schizophrenia Symptoms
Time frame: Change from baseline in Total PANSS score after 6 month treatment
schizophrenia symptoms will be measures using the Positive and Negative Symptom Scale (PANSS) Total PANSS score (range: 30-210). Individual items scored from 1(absent) to 7 (extremely severe). Total PANSS score is sum of the 30 individual items with lowest score (30) indicating all symptoms absent and the maximum score (210) indicating all symptoms rated as extremely severe.

Results and safety

Results posted to the registry on 2 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ITI-007	4	1

Primary outcome: Schizophrenia Symptoms

Time frame: Change from baseline in Total PANSS score after 6 month treatment. Number. Unit: change in PANSS score from baseline

Measure	ITI-007 n = 1
Value	11

Population analysed: Completed participants (6 months of treatment). Outcome measure reported as change in PANSS score from baseline to end of treatment

Adverse events

Time frame: Adverse events to be reported from time of consent (whether received study drug or not) to 30 days after completion of study treatment (up to 8 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ITI-007	1 of 8 (12.5%)	1 of 8 (12.5%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Jeffrey A Lieberman, MD principal investigator

New York State Psychiatric Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ITI-007 in people with Schizophrenia, run by New York State Psychiatric Institute at 1 site in United States.

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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 4 Nov 2021. 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 United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Schizophrenia Symptoms (time frame: Change from baseline in Total PANSS score after 6 month treatment). 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 NCT03817528.

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 4 Nov 2021.