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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-23

Study Completion Date

2006-07-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Investigators and patients were blinded to each patient's treatment. Only a pharmacist or designated person at the study site were unblinded to each patient's treatment.

Study Groups

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LY2140023

40 mg LY2140023 BID for 28 days

Group Type EXPERIMENTAL

LY2140023

Intervention Type DRUG

Olanzapine

15 mg Olanzapine once daily (QD) for 28 days

Group Type ACTIVE_COMPARATOR

olanzapine

Intervention Type DRUG

Placebo

placebo for 28 days

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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LY2140023

Intervention Type DRUG

olanzapine

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No