A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

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.
    

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 patients with schizophrenia. The study included a 24-week active treatment phase and
      an optional 28-week active treatment extension phase.

      The time to discontinuation due to AEs during Study Period III (24-week active treatment
      phase) was compared between LY2140023 and standard of care using the log-rank test from the
      Kaplan-Meier survival analysis. Patients who completed Study Period III or who discontinued
      for a reason other than AEs were considered as censored observations.

      Secondary objectives were assessed during both Study Period III [Active Treatment Phase] and
      Study Period IV [Active Treatment Extension Phase]) except for treatment-emergent adverse
      events (TEAEs), extrapyramidal symptoms (EPS), electroencephalograms (EEGs),
      electrocardiograms (ECGs) (analysis for Study Period III only) (indicated in "Time Frame" in
      "Results" section)
    

Intervention name(s): LY2140023; aripiprazole; olanzapine; risperidone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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).
Other intervention name(s): pomaglumetad methionil; Abilify; Zyprexa; Risperdal
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment