ITI-007 (Lumateperone Tosylate) for Schizophrenia
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|ClinicalTrials.gov Identifier: NCT03817528|
Recruitment Status : Suspended (This study is temporarily suspended due to COVID-19 pandemic.)
First Posted : January 25, 2019
Last Update Posted : April 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: ITI-007||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||open-label|
|Masking:||None (Open Label)|
|Masking Description:||None (open label)|
|Official Title:||ITI-007 (Lumateperone Tosylate) for Schizophrenia|
|Actual Study Start Date :||March 1, 2019|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||March 1, 2021|
Open-Label ITI-007 40-60 mg
ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events
Other Name: Lumateperone tosylate
- 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.
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): NCT03817528
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Jeffrey A Lieberman, MD||New York State Psychiatric Institute|