At a glance
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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
In Brief
A Phase 2 clinical trial evaluating LY2140023, aripiprazole, and 2 other interventions for Schizophrenia. Completed, enrolled 261 participants across 23 sites in 4 countries.
Detailed 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.
Study Details
Timeline
Interventions
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).