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

Primary Purpose

Schizophrenia

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

LY2140023

Olanzapine

Aripiprazole

Risperidone

Quetiapine

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

LY2140023

Arm Description

20mg, 40mg or 80mg After 104 weeks, patients have the option to continue on treatment until the end of the study

Outcomes

Primary Outcome Measures

Time to discontinuation due to adverse events

Secondary Outcome Measures

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Full Information

NCT ID

NCT01129674

First Posted

May 21, 2010

Last Updated

January 11, 2013

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01129674

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Terminated

Why Stopped

The decision to stop the trial was based on efficacy results in the overall schizophrenia participant population.

Study Start Date

June 2010 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care

Arm Type

Active Comparator

Arm Title

LY2140023

Arm Type

Experimental

Arm Description

20mg, 40mg or 80mg After 104 weeks, patients have the option to continue on treatment until the end of the study

Intervention Type

Drug

Intervention Name(s)

LY2140023

Other Intervention Name(s)

mGlu 2/3 Prodrug II

Intervention Description

Administered orally, twice daily for 104 weeks

Intervention Type

Drug

Intervention Name(s)

Olanzapine

Other Intervention Name(s)

Zyprexa, LY170053

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Aripiprazole

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Risperidone

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Quetiapine

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to discontinuation due to adverse events

Time Frame

Baseline through 52 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

Baseline, 52 weeks

Title

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

Time Frame

Baseline, 52 weeks

Title

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

Time Frame

Baseline, 52 weeks

Title

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

Title

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

Time Frame

Baseline, 52 weeks

Title

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

Time Frame

Baseline, 52 weeks

Title

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

Time Frame

Baseline, 104 weeks

Title

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

Time Frame

Baseline, 104 weeks

Title

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

Time Frame

52 weeks, 104 weeks

Title

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

Time Frame

52 weeks, 104 weeks

Title

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

Time Frame

52 weeks, 104 weeks

Title

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

Time Frame

104 weeks, end of study

Title

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

Time Frame

Baseline, 104 weeks

Title

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

Time Frame

Baseline, 104 weeks

Title

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

Time Frame

Baseline, 52 weeks

Title

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

Time Frame

104 weeks, end of study

Title

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

Time Frame

Baseline, 52 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72201

Country

United States

Facility Name

City

Escondido

State/Province

California

ZIP/Postal Code

92025

Country

United States

Facility Name

City

Garden Grove

State/Province

California

ZIP/Postal Code

92845

Country

United States

Facility Name

City

Long Beach

State/Province

California

ZIP/Postal Code

90813

Country

United States

Facility Name

City

National City

State/Province

California

ZIP/Postal Code

91950

Country

United States

Facility Name

City

Oakland

State/Province

California

ZIP/Postal Code

94612

Country

United States

Facility Name

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

Facility Name

City

Paramount

State/Province

California

ZIP/Postal Code

90723

Country

United States

Facility Name

City

Pasadena

State/Province

California

ZIP/Postal Code

91106

Country

United States

Facility Name

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

City

Sherman Oaks

State/Province

California

ZIP/Postal Code

91403

Country

United States

Facility Name

City

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

Facility Name

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20016

Country

United States

Facility Name

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33308

Country

United States

Facility Name

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

City

Kissimmee

State/Province

Florida

ZIP/Postal Code

34741

Country

United States

Facility Name

City

Maitland

State/Province

Florida

ZIP/Postal Code

32751

Country

United States

Facility Name

City

University Park

State/Province

Florida

ZIP/Postal Code

34201

Country

United States

Facility Name

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30308

Country

United States

Facility Name

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60640

Country

United States

Facility Name

City

Hoffman Estates

State/Province

Illinois

ZIP/Postal Code

60169

Country

United States

Facility Name

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46222

Country

United States

Facility Name

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67207

Country

United States

Facility Name

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70629

Country

United States

Facility Name

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71104

Country

United States

Facility Name

City

Flowood

State/Province

Mississippi

ZIP/Postal Code

39232

Country

United States

Facility Name

City

Creve Coeur

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

City

Marlton

State/Province

New Jersey

ZIP/Postal Code

08053

Country

United States

Facility Name

City

Buffalo

State/Province

New York

ZIP/Postal Code

14215

Country

United States

Facility Name

City

Cedarhurst

State/Province

New York

ZIP/Postal Code

11516

Country

United States

Facility Name

City

Holliswood

State/Province

New York

ZIP/Postal Code

11423

Country

United States

Facility Name

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

City

Rochester

State/Province

New York

ZIP/Postal Code

14615

Country

United States

Facility Name

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45417

Country

United States

Facility Name

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19139

Country

United States

Facility Name

City

Austin

State/Province

Texas

ZIP/Postal Code

78754

Country

United States

Facility Name

City

Dallas

State/Province

Texas

ZIP/Postal Code

75243

Country

United States

Facility Name

City

Desoto

State/Province

Texas

ZIP/Postal Code

75115

Country

United States

Facility Name

City

Houston

State/Province

Texas

ZIP/Postal Code

77008

Country

United States

Facility Name

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Facility Name

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24014

Country

United States

Facility Name

City

Zagreb

ZIP/Postal Code

10090

Country

Croatia

Facility Name

City

Aichi

ZIP/Postal Code

470-1168

Country

Japan

Facility Name

City

Kanagawa

ZIP/Postal Code

210-0013

Country

Japan

Facility Name

City

Kumamoto

ZIP/Postal Code

861-0002

Country

Japan

Facility Name

City

Kyoto

ZIP/Postal Code

625-8502

Country

Japan

Facility Name

City

Nagano

ZIP/Postal Code

384-8540

Country

Japan

Facility Name

City

Nagasaki

ZIP/Postal Code

856-0847

Country

Japan

Facility Name

City

Nara

ZIP/Postal Code

634-8522

Country

Japan

Facility Name

City

Osaka

ZIP/Postal Code

569-1041

Country

Japan

Facility Name

City

Saga

ZIP/Postal Code

842-0192

Country

Japan

Facility Name

City

Tokyo

ZIP/Postal Code

120-0033

Country

Japan

Facility Name

City

Toyama

ZIP/Postal Code

939-8073

Country

Japan

Facility Name

City

Goyang-Si

ZIP/Postal Code

410-719

Country

Korea, Republic of

Facility Name

City

Incheon

ZIP/Postal Code

400-711

Country

Korea, Republic of

Facility Name

City

Naju

ZIP/Postal Code

520-833

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

150-713

Country

Korea, Republic of

Facility Name

City

Suwon-City

ZIP/Postal Code

442-723

Country

Korea, Republic of

Facility Name

City

Yongin

ZIP/Postal Code

446-769

Country

Korea, Republic of

Facility Name

City

Guadalajara

ZIP/Postal Code

44340

Country

Mexico

Facility Name

City

Monterrey

ZIP/Postal Code

64060

Country

Mexico

Facility Name

City

Ponce

ZIP/Postal Code

00731

Country

Puerto Rico

Facility Name

City

San Juan

ZIP/Postal Code

00926

Country

Puerto Rico

Facility Name

City

Khotkovo

ZIP/Postal Code

127025

Country

Russian Federation

Facility Name

City

Lipetsk

ZIP/Postal Code

399007

Country

Russian Federation

Facility Name

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

City

Nizhniy Novgorod

ZIP/Postal Code

603155

Country

Russian Federation

Facility Name

City

Saint Petersburg

ZIP/Postal Code

190121

Country

Russian Federation

Facility Name

City

Samara

ZIP/Postal Code

443016

Country

Russian Federation

Facility Name

City

Saratov

ZIP/Postal Code

410060

Country

Russian Federation

Facility Name

City

Tomsk

ZIP/Postal Code

634014

Country

Russian Federation

Facility Name

City

Voronezh

ZIP/Postal Code

394071

Country

Russian Federation

Facility Name

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

City

Changhua

ZIP/Postal Code

50550

Country

Taiwan

Facility Name

City

Neihu Taipei

ZIP/Postal Code

114

Country

Taiwan

Facility Name

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

City

Donetsk

ZIP/Postal Code

83037

Country

Ukraine

Facility Name

City

Kherson

ZIP/Postal Code

73488

Country

Ukraine

Facility Name

City

Kiev

ZIP/Postal Code

2660

Country

Ukraine

Facility Name

City

Vinnytsya

ZIP/Postal Code

21005

Country

Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs