Study of LY2140023 in Schizophrenia Comparing LY2140023, Olanzapine, and Placebo

Denovo Biopharma

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: LY2140023; Drug: placebo; Drug: olanzapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00149292

H8Y-BD-HBBD

9777

Details and patient eligibility

About

Assess the efficacy of a new drug (a receptor agonist that modulates the glutamatergic activity) in the treatment of schizophrenia.

The primary objective of this study is to determine if a mGlu2/3 agonist dosed for 28 days is superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Symptom Scales (PANSS) total score.

Full description

The primary objective of this study was to determine if LY2140023 dosed at 40 mg twice daily (BID) for 28 days was superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) total score. The secondary objectives of the study were to assess the safety and tolerability of LY2140023 compared with placebo and olanzapine; efficacy of LY2140023 compared with placebo in change from baseline to Visit 8 in the PANSS positive symptom subset score; efficacy of LY2140023 compared with placebo in the responder rate (defined as 25% or more decrease from baseline to Visit 8) in the PANSS total score; efficacy of LY2140023 compared with placebo in responder rate (defined as 25% or more decrease from baseline to Visit 8) in the PANSS positive symptom subset score; efficacy of LY2140023 compared with placebo in change from baseline to Visit 8 in the PANSS negative symptom subset score; efficacy of LY2140023 compared with placebo in change from baseline to Visit 8 in mood and anxiety as measured by the Hamilton Anxiety Scale (HAMA) total score; efficacy of LY2140023 compared with placebo in change from baseline to Visit 8 in the Clinical Global Impression-Severity (CGI-S); effect of LY2140023 on prolactin levels of the patients after 4 weeks of treatment; efficacy of olanzapine compared with placebo on the PANSS total score; pharmacokinetics of LY2140023 and LY404039 in patients, and to explore the relationship between exposure and efficacy.

Enrollment: 195 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• meet the DSM-IV criteria for schizophrenia as confirmed by modified SCID

Exclusion criteria

• meet the full syndromal criteria for other Axis I disorder
• have taken any depot antipsychotic within 4 weeks before screening
• are taking mood-stabilizing agents

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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195 participants in 3 patient groups, including a placebo group

LY2140023

Experimental group

Description:

40 mg LY2140023 BID for 28 days

Treatment:

Drug: LY2140023

Olanzapine

Active Comparator group

Description:

15 mg Olanzapine once daily (QD) for 28 days

Treatment:

Drug: olanzapine

Placebo

Placebo Comparator group

Description:

placebo for 28 days

Treatment:

Drug: placebo