A Long-Term, Phase 2, Multicenter, Randomized, Open-Label Comparative Safety Study of LY2140023 Versus Atypical Antipsychotic Standard of Care in Patients With DSM-IV-TR Schizophrenia

12648

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, versus those on atypical antipsychotic standard-of-care (SOC) treatment. Lack of tolerability was defined as discontinuation due to adverse events (AEs). Patients who completed the active treatment phase were eligible to continue to an optional 28 weeks of treatment extension phase. This extension phase assessed key safety and efficacy measures.

2009-03-01

2010-05-01

2010-12-01

Completed

Early phase I

261

Inclusion Criteria: * 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 Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 261, 'type': 'ACTUAL'}}

2022-11-08