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

D

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

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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