3817528
Last Update Posted: 2021-11-04
Recruiting has ended
Males accepted | 18 Years-60 Years |
4 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
ITI-007 (Lumateperone Tosylate) for Schizophrenia
The purpose of this study is to offer open label ITI-007 treatment to patients who poorly respond or poorly tolerate approved medications.
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.
Eligibility
Relevant conditions:
Schizophrenia
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov