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OpenTrials
Completed

NCT Number: NCT00520923

A Study for Patients With Schizophrenia

The purpose of this study is to test the hypothesis that 1 or more dose levels of LY2140023 given orally to patients with schizophrenia twice daily for 4 weeks will have significantly greater effect than placebo.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Banfield, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Some Inclusion Criteria:

  • Patients must have a diagnosis of Schizophrenia as defined in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (Disorganized, 295.10; Catatonic, 295.20; Paranoid, 295.30; Residual, 295.60; or Undifferentiated, 295.90) and confirmed by the Structured Clinical Interview for DSM-IV (SCID).
  • Patients must meet the following psychopathologic severity criteria at Visit 1: Brief Psychiatric Rating Scale (BPRS) total score, extracted from the Positive and Negative Syndrome Scale (PANSS), of at least 45 (18-item version, in which 1 indicates "absent" and 7 indicates "severe"). In addition, item scores of at least 4 (moderate) will be required on 2 of the following BPRS items: conceptual disorganization, suspiciousness, hallucinatory behavior, and/or unusual thought content.
  • Patients must receive a rating of 4 (moderately ill) or greater on the Clinical Global Impression-Severity (CGI-S) scale at Visit 1.
  • Patients in whom, in the opinion of the investigator, a switch to another antipsychotic medication or initiation of an antipsychotic medication is acutely indicated.

Some Exclusion Criteria:

  • Patients in whom treatment with olanzapine or placebo is relatively or absolutely clinically contraindicated.
  • Patients who have a history of inadequate response to an adequate treatment trial with olanzapine, in the opinion of the investigator.
  • Patients who have received treatment with olanzapine within 6 weeks prior to Visit 1.
  • Patients who have received treatment with clozapine at doses greater than 200 mg daily within 12 months prior to Visit 1, or who have received any clozapine at all during the month before Visit 1.
  • Patients who have a history of an inadequate response, in the opinion of the investigator, to 2 or more adequate antipsychotic medication trials of at least 8 weeks duration in the past 12 months prior to Visit 1.
  • Patients with acute, serious, or unstable medical conditions, including (but not limited to) inadequately controlled diabetes (hemoglobin A1c (HbA1c) 8%), severe hypertriglyceridemia (fasting triglycerides 5.6 mmol/L, recent cerebrovascular accidents, serious acute systemic infection or immunologic disease, unstable cardiovascular disorders (including ischemic heart disease), malnutrition, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, or hematologic diseases.

Treatment and study plan

LY2140023

Drug

80mg, PO (by mouth) BID (twice a day) for up to 4 weeks.

Olanzapine

Drug

10mg, PO (by mouth) QPM (every evening) for the first 3 days, then 15mg PO QPM, for up to 4 weeks.

Placebo

Drug

Taken PO (by mouth) QAM (every morning) for up to 4 weeks.

Primary outcomes

  1. Positive and Negative Syndrome Scale (PANSS) total score

    Time frame: over 4 weeks of treatment

Secondary outcomes

  1. PANSS subscores: positive subscore; negative subscore; general psychopathology subscore and cognitive subscore

    Time frame: over 4 weeks of treatment

  2. Clinical Global Impression-Severity (CGI-S)

    Time frame: over 4 weeks of treatment

  3. Drug Attitude Inventory-10 (DAI-10)

    Time frame: over 4 weeks of treatment

  4. Response and Remission Rates

    Time frame: over 4 weeks of treatment

  5. Assessment of Cognition in Schizophrenia (BACS) Symbol Coding Task

    Time frame: over 4 weeks of treatment

  6. Montgomery-Asberg Depression RatingScale (MADRS)

    Time frame: over 4 weeks of treatment

  7. Safety and Tolerability

    Time frame: over 4 weeks of treatment

  8. Pharmacokinetics

    Time frame: over 4 weeks of treatment

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Multi-Center, Inpatient, Phase 2, Double-blind, Placebo-Controlled Dose Ranging Study of LY2140023 in Patients With DSM-IV Schizophrenia

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 27, 2007
Registry last updated
Oct 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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