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OpenTrials
Terminated

NCT Number: NCT01129674

A Long-Term, Open-Label, Study on Schizophrenia

The primary purpose of the study is to help answer the following research questions:

How LY 2140023 can be tolerated by patients with Schizophrenia compared to standard of care treatment in 52 weeks time period.

Whether LY 2140023 can help patients with Schizophrenia.

Why the study stopped: The decision to stop the trial was based on efficacy results in the overall schizophrenia participant population.
Terminated

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

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., Zagreb, Croatia

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About this study

The study includes 2 treatment periods. Study Period I will begin at participant randomization (enrollment into Study HBBO) and continue through the first 2 years of treatment. Study Period II will be only for participants randomized to treatment with LY2140023, and will begin after the participant has completed the second year of treatment. Participants who qualify for enrollment will be randomized in a 3:1 ratio (LY2140023 versus standard of care, respectively) into 2 treatment groups: flexible, twice-daily dose of LY2140023 or standard-of-care (olanzapine, risperidone, aripiprazole, or quetiapine). Those assigned to LY2140023 will have the option to continue on LY2140023 after 2 years if deemed appropriate by the investigator.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must have met all entry criteria for, and have completed, an acute, placebo-controlled clinical trial of LY2140023 (such as Study H8Y-MC-HBBM, or other acute, placebo-controlled LY2140023 studies if allowed by the protocols for those studies).
  • Female participants of childbearing potential must agree to use a single, effective, medically acceptable method of birth control.
  • Participants must be considered reliable and have a level of understanding sufficient to perform all tests and examinations required by the protocol.
  • Participants must be able to understand the nature of the study and have given their own informed consent.

Exclusion criteria

  • Are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an investigational product or nonapproved use of a drug or device (other than LY2140023), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Participants for whom treatment with olanzapine, risperidone, aripiprazole, quetiapine, or LY2140023, as specified in this protocol, is relatively or absolutely clinically contraindicated.
  • Participants who have received treatment with clozapine at doses greater than 200 mg daily within 12 months prior to study enrollment, or who have received any clozapine at all during the month before study enrollment.
  • Participants who require concomitant treatment with any other medication with primary central nervous system activity, other than those allowed in study protocol.
  • Participants have risk of suicide.
  • Participants diagnosed with substance dependence or substance abuse within the 6 months prior to study enrollment.
  • Participants diagnosed with substance-induced psychosis within 7 days of study enrollment or at any time during the study.
  • Female participants who are pregnant, nursing, lactating or who intend to become pregnant within 30 days of completing the study.
  • Have known glaucoma.
  • Have a history of some types of seizures.
  • Have seizure liability inconsistent with the exclusion criteria of the completed acute feeder study.
  • Participants who have had electroconvulsive therapy (ECT) within 3 months of study enrollment or who will have ECT at any time during the study.
  • Participants with known Human Immunodeficiency Virus positive (HIV+) status.
  • Participants have a serious disease, such as recent stroke, heart, liver, kidney, lung or blood diseases
  • Participants with Parkinson's disease
  • Are incapable of participating in the study or are unwilling to engage in a meaningful way as study participants.

Treatment and study plan

LY2140023

Drug

Administered orally, twice daily for 104 weeks

Other names: metabotropic glutamate (mGlu) 2/3 Prodrug II

Olanzapine

Drug

Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks

Other names: Zyprexa, LY170053

Aripiprazole

Drug

Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks

Risperidone

Drug

Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks

Quetiapine

Drug

Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks

Primary outcomes

  1. Time to discontinuation due to adverse events

    Time frame: Baseline through 52 weeks

Secondary outcomes

  1. Change from baseline to 52 weeks endpoint in PANSS (Positive and Negative Syndrome Scale)

    Time frame: Baseline, 52 weeks

  2. Change from baseline to 52 week endpoint in Clinical Global Impression-Severity (CGI-S)

    Time frame: Baseline, 52 weeks

  3. Change from baseline to 52 week endpoint in NSA-16 (16-item Negative Symptoms Assessment)

    Time frame: Baseline, 52 weeks

  4. The number of patients with statistically significant changes (treatment emergent ideation and behavior; improvement) based on the Columbia Suicide Severity Rating Scale (C-SSRS)

    Time frame: 52 weeks, 104 weeks, end of study

  5. Change from baseline to 52 week endpoint in PSP scale (Personal and Social Performance)

    Time frame: Baseline, 52 weeks

  6. Change from baseline to 52 week endpoint in the SWN Scale (Subjective Well-Being Under Neuroleptic Treatment)

    Time frame: Baseline, 52 weeks

  7. Change from baseline to 104 week endpoint in the Schizophrenia Resource Use Model (S-RUM)

    Time frame: Baseline, 104 weeks

  8. Change from baseline to 104 week endpoint in the EuroQoL Questionnaire-5 Dimension (EQ-5D)

    Time frame: Baseline, 104 weeks

  9. Change from 52 week to 104 week endpoint in PANSS (Positive and Negative Syndrome Scale)

    Time frame: 52 weeks, 104 weeks

  10. Change from 52 week to 104 week endpoint in Clinical Global Impression-Severity (CGI-S)

    Time frame: 52 weeks, 104 weeks

  11. Change from 52 week to 104 week endpoint in NSA-16 (16-item Negative Symptoms Assessment)

    Time frame: 52 weeks, 104 weeks

  12. Change from 104 week to study endpoint in Clinical Global Impression-Severity (CGI-S)

    Time frame: 104 weeks, end of study

  13. Change from baseline to 104 week endpoint in PSP scale (Personal and Social Performance)

    Time frame: Baseline, 104 weeks

  14. Change from baseline to 104 week endpoint in the SWN Scale (Subjective Well-Being Under Neuroleptic Treatment)

    Time frame: Baseline, 104 weeks

  15. Change from Baseline to 52 week endpoint in the Schizophrenia Resource Use Model (S-RUM)

    Time frame: Baseline, 52 weeks

  16. Change from 104 week to study endpoint in the EuroQoL Questionnaire-5 Dimension (EQ-5D)

    Time frame: 104 weeks, end of study

  17. Change from baseline to 52 weeks endpoint in PANSS (Positive and Negative Syndrome Scale) in a genetically defined subgroup

    Time frame: Baseline, 52 Weeks

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Denovo Biopharma LLC

Industry

Registry information

Official study title

A Long-Term, Open-Label, Multicenter Study of LY2140023 Compared to Atypical Antipsychotic Standard of Care in Patients With DSM-IV-TR Schizophrenia

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 25, 2010
Registry last updated
Sep 14, 2026

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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