Status:
COMPLETED
A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients
Lead Sponsor:
Denovo Biopharma LLC
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The primary objective of this study was to assess time to discontinuation due to lack of tolerability among patients with schizophrenia receiving LY2140023, given orally twice daily for 24 weeks, vers...
Detailed Description
A Phase 2, multicenter, randomized, parallel, open-label study comparing the long-term safety and tolerability of LY2140023 with atypical antipsychotic agents considered to be the current SOC for pati...
Eligibility Criteria
Inclusion
- Clinical diagnosis of schizophrenia
- Patients, in the investigator's opinion, must require a switch to another antipsychotic medication as clinically indicated or initiation of an antipsychotic agent
- Patients must be willing and able to be hospitalized, or to remain hospitalized (if already hospitalized), for up to 17 days
- The investigator expects, at the time of enrollment, that the patient will be able to be discharged from the hospital after the first 2 weeks of active treatment
- Disease symptoms must meet a certain range as assessed by the clinician
- Patients must have evidence of functional impairment (i.e. social or vocational deficiency)
- Patients must be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures
- Patients must be able to understand the nature of the study and have given their informed consent
Exclusion
- Patients who are actively suicidal
- Patients who are pregnant or nursing
- Patients who have had electroconvulsive therapy (ECT) within 3 months of screening or who will have ECT at any time during the study
- Patients with uncorrected narrow-angle glaucoma, seizures, uncontrolled diabetes, certain diseases of the liver, uncontrolled thyroid condition or other serious or unstable illnesses
- Patients with Parkinson's disease, psychosis related to dementia or related disorders
- Patients with known Human Immunodeficiency Virus positive (HIV+) status
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
261 Patients enrolled
Trial Details
Trial ID
NCT00845026
Start Date
March 1 2009
End Date
December 1 2010
Last Update
November 8 2022
Active Locations (23)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Escondido, California, United States, 92025
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Garden Grove, California, United States, 92845
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Washington D.C., District of Columbia, United States, 20016
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chicago, Illinois, United States, 60640