Schizophrenia
Conditions
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.
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.
Interventions
DRUGITI-007
ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events
Sponsors
Intra-Cellular Therapies, Inc.
New York State Psychiatric Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
None (open label)
Intervention model description
open-label
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Enrollment reflects the number of participants were deemed eligible and received study drug
Pre-assignment details
Participants underwent a screening phase to determine eligibility to receive study medication
Participants by arm
| Arm | Count |
|---|---|
| ITI-007 Open-Label ITI-007 40-60 mg
ITI-007: ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | ITI-007 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 4 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 1 / 8 |
| serious Total, serious adverse events | 1 / 8 |
Outcome results
Primary
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.
Time frame: Change from baseline in Total PANSS score after 6 month treatment
Population: Completed participants (6 months of treatment). Outcome measure reported as change in PANSS score from baseline to end of treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ITI-007 | Schizophrenia Symptoms | 11 change in PANSS score from baseline |