A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: LY2140023; aripiprazole; olanzapine; risperidone
Intervention description: 80 milligram (mg), oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.; 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).; 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).; 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 261.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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, 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.
    

Eligibility criteria:

        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