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

This study has been terminated.
(The decision to stop the trial was based on efficacy results in the overall schizophrenia participant population.)
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01129674
First received: May 21, 2010
Last updated: January 11, 2013
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: LY2140023
Drug: Olanzapine
Drug: Aripiprazole
Drug: Risperidone
Drug: Quetiapine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-Term, Open-Label, Multicenter Study of LY2140023 Compared to Atypical Antipsychotic Standard of Care in Patients With DSM-IV-TR Schizophrenia

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Time to discontinuation due to adverse events [ Time Frame: Baseline through 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline to 52 weeks endpoint in PANSS (Positive and Negative Syndrome Scale) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 week endpoint in Clinical Global Impression-Severity (CGI-S) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 week endpoint in NSA-16 (16-item Negative Symptoms Assessment) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Change from baseline to 52 week endpoint in PSP scale (Personal and Social Performance) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 week endpoint in the SWN Scale (Subjective Well-Being Under Neuroleptic Treatment) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 104 week endpoint in the Schizophrenia Resource Use Model (S-RUM) [ Time Frame: Baseline, 104 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 104 week endpoint in the EuroQoL Questionnaire-5 Dimension (EQ-5D) [ Time Frame: Baseline, 104 weeks ] [ Designated as safety issue: No ]
  • Change from 52 week to 104 week endpoint in PANSS (Positive and Negative Syndrome Scale) [ Time Frame: 52 weeks, 104 weeks ] [ Designated as safety issue: No ]
  • Change from 52 week to 104 week endpoint in Clinical Global Impression-Severity (CGI-S) [ Time Frame: 52 weeks, 104 weeks ] [ Designated as safety issue: No ]
  • Change from 52 week to 104 week endpoint in NSA-16 (16-item Negative Symptoms Assessment) [ Time Frame: 52 weeks, 104 weeks ] [ Designated as safety issue: No ]
  • Change from 104 week to study endpoint in Clinical Global Impression-Severity (CGI-S) [ Time Frame: 104 weeks, end of study ] [ Designated as safety issue: No ]
  • Change from baseline to 104 week endpoint in PSP scale (Personal and Social Performance) [ Time Frame: Baseline, 104 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 104 week endpoint in the SWN Scale (Subjective Well-Being Under Neuroleptic Treatment) [ Time Frame: Baseline, 104 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to 52 week endpoint in the Schizophrenia Resource Use Model (S-RUM) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from 104 week to study endpoint in the EuroQoL Questionnaire-5 Dimension (EQ-5D) [ Time Frame: 104 weeks, end of study ] [ Designated as safety issue: No ]
  • Change from baseline to 52 weeks endpoint in PANSS (Positive and Negative Syndrome Scale) in a genetically defined subgroup [ Time Frame: Baseline, 52 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1210
Study Start Date: June 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard of Care Drug: Olanzapine
Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks
Other Names:
  • Zyprexa
  • LY170053
Drug: Aripiprazole
Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks
Drug: Risperidone
Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks
Drug: Quetiapine
Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks
Experimental: LY2140023

20mg, 40mg or 80mg

After 104 weeks, patients have the option to continue on treatment until the end of the study

Drug: LY2140023
Administered orally, twice daily for 104 weeks
Other Name: mGlu 2/3 Prodrug II

Detailed Description:

The study includes 2 treatment periods. Study Period I will begin at patient randomization (enrollment into Study HBBO) and continue through the first 2 years of treatment. Study Period II will be only for patients randomized to treatment with LY2140023, and will begin after the patient has completed the second year of treatment. Patients 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 patients of childbearing potential must agree to use a single, effective, medically acceptable method of birth control.
  • Patients must be considered reliable and have a level of understanding sufficient to perform all tests and examinations required by the protocol.
  • Patients 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.
  • Patients for whom treatment with olanzapine, risperidone, aripiprazole, quetiapine, or LY2140023, as specified in this protocol, is relatively or absolutely clinically contraindicated.
  • Patients 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.
  • Patients who require concomitant treatment with any other medication with primary central nervous system activity, other than those allowed in study protocol.
  • Patients have risk of suicide.
  • Patients diagnosed with substance dependence or substance abuse within the 6 months prior to study enrollment.
  • Patients diagnosed with substance-induced psychosis within 7 days of study enrollment or at any time during the study.
  • Female patients 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.
  • Patients who have had electroconvulsive therapy (ECT) within 3 months of study enrollment or who will have ECT at any time during the study.
  • Patients with known Human Immunodeficiency Virus positive (HIV+) status.
  • Patients have a serious disease, such as recent stroke, heart, liver, kidney, lung or blood diseases
  • Patients with Parkinson's disease
  • Are incapable of participating in the study or are unwilling to engage in a meaningful way as study participants.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01129674

  Show 81 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01129674     History of Changes
Other Study ID Numbers: 11960, H8Y-MC-HBBO
Study First Received: May 21, 2010
Last Updated: January 11, 2013
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Croatia: Agency for Medicinal Product and Medical Devices
Russia: Ministry of Health of the Russian Federation
Japan: Pharmaceuticals and Medical Devices Agency
Romania: Ministry of Public Health

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on October 19, 2014