Cited by 261Schizophrenia research and treatmentNeuroscience and Neuropharmacology ResearchTreatment of Major Depression

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A Multicenter, Inpatient, Phase 2, Double-Blind, Placebo-Controlled Dose-Ranging Study of LY2140023 Monohydrate in Patients With DSM-IV Schizophrenia

Kinon, Bruce J., Zhang, Lu, Millen, Brian A., Osuntokun, Olawale O., Williams, Judy E., Kollack-Walker, Sara, Jackson, Kimberley, Kryzhanovskaya, Ludmila, Jarkova, Natalia·2011·Journal of Clinical Psychopharmacology

DOI 10.1097/jcp.0b013e318218dcd5

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Abstract

The primary objective of this study was to test the hypothesis that 1 or more dose levels of LY2140023 monohydrate, an oral prodrug of the potent metabotropic glutamate (mGlu) 2/3 receptor agonist LY404039, given to patients with schizophrenia for 4 weeks would demonstrate significantly greater efficacy than placebo. The HBBI study was a multicenter, randomized, double-blind, parallel, placebo- and active-controlled trial. Male and female patients aged 18 to 65 years who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for schizophrenia were randomized in a 2:2:2:2:2:1 ratio to receive 5-, 20-, 40-, or 80-mg LY2140023 monohydrate twice daily, placebo twice daily, or placebo (am) and 15 mg of olanzapine (pm) daily. Efficacy was defined as the change from baseline on the Positive and Negative Syndrome Scale (PANSS) total score assessed at 4 weeks. The primary analysis did not show that any of the 4 LY2140023 monohydrate doses were more efficacious than placebo as measured by the PANSS total score. Similarly, olanzapine did not significantly separate from placebo. A higher-than-anticipated treatment effect (14.6-point improvement) in the placebo group was observed on PANSS total score. LY2140023 monohydrate was generally well tolerated, although 4 patients reported the serious adverse event of convulsion. LY2140023 monohydrate-treated patients showed little change in dopamine-related adverse events and weight. The results of the HBBI study are considered to be inconclusive because LY2140023 monohydrate and the active control olanzapine did not separate from placebo in the treatment of patients with acutely exacerbated schizophrenia. Additional efficacy, safety, and tolerability testing are needed.

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Authors: Kinon, B. J., Zhang, L., Millen, B. A., Osuntokun, O. O., Williams, J. E., Kollack-Walker, S., Jackson, K., Kryzhanovskaya, L., & Jarkova, N.
Affiliations: Eli Lilly (United States) (US)
Corresponding author: Kinon, Bruce J.
Zhang, Lu
Millen, Brian A.
Osuntokun, Olawale O.
Williams, Judy E.
Jackson, Kimberley
Kryzhanovskaya, Ludmila
ORCID: Millen, Brian A.
Jackson, Kimberley
Venue: Journal of Clinical Psychopharmacology
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2011-06
Volume: 31
Issue: 3
Pages: 349-355
ISSN: 0271-0749 (ISSN-L)
DOI: 10.1097/jcp.0b013e318218dcd5
OpenAlex: W2312770619
Cited by: 256
References: 15
Citations by year: 2026: 5 · 2025: 7 · 2024: 9 · 2023: 4 · 2022: 17 · 2021: 9 · 2020: 10 · 2019: 13 · 2018: 12 · 2017: 13 · 2016: 19 · 2015: 28 · 2014: 29 · 2013: 34 · 2012: 39
FWCI: 24.04
Type: journal article
Language: en
Open access: closed
Locations: Journal of Clinical Psychopharmacology (publishedVersion)
PubMed (publishedVersion)
Funders: Eli Lilly and Company
Topics: Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neuroscience and Neuropharmacology Research
Health Sciences › Medicine › Pharmacology (medical) › Treatment of Major Depression
Keywords: prodrugs, schizophrenia, acute exacerbation of schizophrenia, olanzapine, dose-ranging, PANSS, convulsions, weight change, drug safety and tolerability
MeSH terms: Olanzapine, Assessment of Medication Adherence, Adolescent, Adult, Aged, Amino Acids, Benzodiazepines, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Inpatients, Male, Middle Aged, Prodrugs, Psychiatric Status Rating Scales, Schizophrenia, Antipsychotic Agents, Drug Monitoring, Receptors, Metabotropic Glutamate, Diagnostic and Statistical Manual of Mental Disorders, Medication Adherence

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A Multicenter, Inpatient, Phase 2, Double-Blind, Placebo-Controlled Dose-Ranging Study of LY2140023 Monohydrate in Patients With DSM-IV Schizophrenia

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