ITI-007 (Lumateperone Tosylate) for Schizophrenia
Study Details
Study Description
Brief Summary
The purpose of this study is to offer open label ITI-007 treatment to patients who poorly respond or poorly tolerate approved medications.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ITI-007 Open-Label ITI-007 40-60 mg |
Drug: ITI-007
ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Schizophrenia Symptoms [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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)
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New York State Psychiatric Institute | New York | New York | United States | 10032 |
Sponsors and Collaborators
- New York State Psychiatric Institute
- Intra-Cellular Therapies, Inc.
Investigators
- Principal Investigator: Jeffrey A Lieberman, MD, New York State Psychiatric Institute
Study Documents (Full-Text)
More Information
Publications
None provided.- 7716
Study Results
Participant Flow
| Recruitment Details | Enrollment reflects the number of participants were deemed eligible and received study drug |
|---|---|
| Pre-assignment Detail | Participants underwent a screening phase to determine eligibility to receive study medication |
| Arm/Group Title | ITI-007 |
|---|---|
| Arm/Group Description | Open-Label ITI-007 40-60 mg ITI-007: ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events |
| Period Title: Overall Study | |
| STARTED | 4 |
| COMPLETED | 1 |
| NOT COMPLETED | 3 |
Baseline Characteristics
| Arm/Group Title | ITI-007 |
|---|---|
| Arm/Group Description | Open-Label ITI-007 40-60 mg ITI-007: ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events |
| Overall Participants | 4 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
4
100%
|
| >=65 years |
0
0%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
0
0%
|
| Male |
4
100%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
0
0%
|
| Not Hispanic or Latino |
4
100%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
1
25%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
3
75%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (Count of Participants) | |
| United States |
4
100%
|
Outcome Measures
| Title | Schizophrenia Symptoms |
|---|---|
| Description | 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. |
| Time Frame | Change from baseline in Total PANSS score after 6 month treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Completed participants (6 months of treatment). Outcome measure reported as change in PANSS score from baseline to end of treatment |
| Arm/Group Title | ITI-007 |
|---|---|
| Arm/Group Description | Open-Label ITI-007 40-60 mg ITI-007: ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events |
| Measure Participants | 1 |
| Number [change in PANSS score from baseline] |
11
|
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) | |
|---|---|---|
| Adverse Event Reporting Description | AE/SAE collection from all individuals who signed informed consent (total: 8) | |
| Arm/Group Title | ITI-007 | |
| Arm/Group Description | Open-Label ITI-007 40-60 mg ITI-007: ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events | |
All Cause Mortality |
||
| ITI-007 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | |
Serious Adverse Events |
||
| ITI-007 | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/8 (12.5%) | |
| Psychiatric disorders | ||
| worsening of symptoms | 1/8 (12.5%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| ITI-007 | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/8 (12.5%) | |
| Gastrointestinal disorders | ||
| vomiting | 1/8 (12.5%) | 1 |
| Psychiatric disorders | ||
| hypomania | 1/8 (12.5%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Marlene Carlson, MPH |
|---|---|
| Organization | New York State Psychiatric Institute |
| Phone | 646-774-5340 |
| marlene.carlson@nyspi.columbia.edu |
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