Investigational Agent Targeting Metabotropic Glutamate 2/3 Receptors Demonstrates Antipsychotic Activity in Humans, Study in Nature Medi... (ia and perhaps otherneuropsychiatric dis...)

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Investigational Agent Targeting Metabotropic Glutamate 2/3 Receptors Demonstrates Antipsychotic Activity in Humans, Study in Nature Medicine Finds

Date:9/2/2007

ia and, perhaps, other neuropsychiatric disorders," said Steven Paul, M.D., Lilly's executive vice president of science and technology. "Additional and longer-term studies are needed to confirm and extend these exciting initial findings. However, these data suggest that LY2140023 may provide a new alternative for the treatment of this often devastating condition."

Study Design

The trial was a proof of concept study designed to determine LY2140023 superiority versus placebo. Olanzapine was used as an active control. 196 patients with schizophrenia were randomly assigned to LY2140023 (40 mg twice daily), olanzapine (15 mg daily) or placebo. All participants were hospitalized to ensure patient safety, tapered off from any pre-trial antipsychotic medications (no therapeutically stable patients were included in the trial), and treated in a double-blind manner for four weeks. In all, 118 patients completed four weeks of the planned study treatment.

Results

Treatment with LY2140023 or olanzapine resulted in statistically significant improvement in PANSS (Positive and Negative Syndrome Scale) total score (primary outcome) compared to placebo (-20.8, P < 0.001; -26.7, P < 0.001; respectively), After four weeks of treatment, the study showed that both the LY2140023 group (32.0%, P < 0.001) and the olanzapine group (41.2%, P < 0.001) demonstrated significantly greater response rates compared to the placebo group (3.2%). Response was measured primarily by the PANSS, the most common scale used for measuring symptoms of patients with schizophrenia. A patient showing a 25% or more decrease in PANSS total score was defined as a responder. Additionally, a mean 0.51-kg weight reduction from baseline was observed in the LY2140023 group. A moderate but statistically significant weight gain was observed in the olanzapine group (0.74 kg, P = 0.017) relative to the placebo group.

Results showed that the placebo arm experienced the highest rate of study discon
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