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A Study for Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

LY2140023

Olanzapine

Placebo

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

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.

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Arm Description

160mg of LY2140023, taken orally as 80mg twice daily, for up to 4 weeks.

80mg of LY2140023, taken orally as 40mg twice daily, for up to 4 weeks.

40mg of LY2140023, taken orally as 20mg twice daily, for up to 4 weeks.

10mg of LY2140023, taken orally as 5mg twice daily, for up to 4 weeks.

Placebo of LY2140023, taken orally twice daily, for up to 4 weeks.

Placebo, taken orally every morning, followed by Olanzapine 15mg taken orally every evening for up to 4 weeks.

Outcomes

Primary Outcome Measures

Positive and Negative Syndrome Scale (PANSS) total score

Secondary Outcome Measures

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

Clinical Global Impression-Severity (CGI-S)

Drug Attitude Inventory-10 (DAI-10)

Response and Remission Rates

Assessment of Cognition in Schizophrenia (BACS) Symbol Coding Task

Montgomery-Asberg Depression RatingScale (MADRS)

Safety and Tolerability

Pharmacokinetics

Full Information

NCT ID

NCT00520923

First Posted

August 24, 2007

Last Updated

October 16, 2009

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00520923

Brief Title

A Study for Patients With Schizophrenia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

654 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

160mg of LY2140023, taken orally as 80mg twice daily, for up to 4 weeks.

Arm Title

Arm Type

Experimental

Arm Description

80mg of LY2140023, taken orally as 40mg twice daily, for up to 4 weeks.

Arm Title

Arm Type

Experimental

Arm Description

40mg of LY2140023, taken orally as 20mg twice daily, for up to 4 weeks.

Arm Title

Arm Type

Experimental

Arm Description

10mg of LY2140023, taken orally as 5mg twice daily, for up to 4 weeks.

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo of LY2140023, taken orally twice daily, for up to 4 weeks.

Arm Title

Arm Type

Active Comparator

Arm Description

Placebo, taken orally every morning, followed by Olanzapine 15mg taken orally every evening for up to 4 weeks.

Intervention Type

Drug

Intervention Name(s)

LY2140023

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

LY2140023

Intervention Description

40mg, PO (by mouth) BID (twice daily) for up to 4 weeks.

Intervention Type

Drug

Intervention Name(s)

LY2140023

Intervention Description

20mg, PO (by mouth) BID (twice daily) for up to 4 weeks.

Intervention Type

Drug

Intervention Name(s)

LY2140023

Intervention Description

5mg, PO (by mouth) BID (twice daily) for up to 4 weeks.

Intervention Type

Drug

Intervention Name(s)

Olanzapine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Taken PO (by mouth) BID (twice daily) for up to 4 weeks.

Primary Outcome Measure Information:

Title

Positive and Negative Syndrome Scale (PANSS) total score

Time Frame

over 4 weeks of treatment

Secondary Outcome Measure Information:

Title

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

Time Frame

over 4 weeks of treatment

Title

Clinical Global Impression-Severity (CGI-S)

Time Frame

over 4 weeks of treatment

Title

Drug Attitude Inventory-10 (DAI-10)

Time Frame

over 4 weeks of treatment

Title

Response and Remission Rates

Time Frame

over 4 weeks of treatment

Title

Assessment of Cognition in Schizophrenia (BACS) Symbol Coding Task

Time Frame

over 4 weeks of treatment

Title

Montgomery-Asberg Depression RatingScale (MADRS)

Time Frame

over 4 weeks of treatment

Title

Safety and Tolerability

Time Frame

over 4 weeks of treatment

Title

Pharmacokinetics

Time Frame

over 4 weeks of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

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

Banfield

ZIP/Postal Code

B1828CKR

Country

Argentina

Facility Name

City

Buenos Aires

ZIP/Postal Code

C1424CAB

Country

Argentina

Facility Name

City

Lanus Este

ZIP/Postal Code

B18241BR

Country

Argentina

Facility Name

City

Munro

ZIP/Postal Code

1605

Country

Argentina

Facility Name

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Facility Name

City

Osijek

ZIP/Postal Code

HR-31000

Country

Croatia

Facility Name

City

Split

ZIP/Postal Code

21000

Country

Croatia

Facility Name

City

Zagreb

ZIP/Postal Code

HR-10090

Country

Croatia

Facility Name

City

Aachen

ZIP/Postal Code

D-52057

Country

Germany

Facility Name

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

City

München

ZIP/Postal Code

D-81675

Country

Germany

Facility Name

City

Mexico City

ZIP/Postal Code

14420

Country

Mexico

Facility Name

City

Monterrey

ZIP/Postal Code

64000

Country

Mexico

Facility Name

City

Lisbon

ZIP/Postal Code

1350-190

Country

Portugal

Facility Name

City

Porto

ZIP/Postal Code

4200-272

Country

Portugal

Facility Name

City

Bucharest

ZIP/Postal Code

73120

Country

Romania

Facility Name

City

Craiova

ZIP/Postal Code

200738

Country

Romania

Facility Name

City

Iasi

ZIP/Postal Code

700282

Country

Romania

Facility Name

City

Targu Mures

ZIP/Postal Code

540139

Country

Romania

Facility Name

City

Kazan

ZIP/Postal Code

420012

Country

Russian Federation

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

123367

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

Village Nikolskoe

ZIP/Postal Code

188357

Country

Russian Federation

Facility Name

City

Bloemfontein

ZIP/Postal Code

9300

Country

South Africa

Facility Name

City

Cape Town

ZIP/Postal Code

7530

Country

South Africa

Facility Name

City

Durban

ZIP/Postal Code

4000

Country

South Africa

Facility Name

City

Johannesburg

ZIP/Postal Code

2198

Country

South Africa

Facility Name

City

Pretoria

ZIP/Postal Code

0181

Country

South Africa

Facility Name

City

Randburg

ZIP/Postal Code

2125

Country

South Africa

12. IPD Sharing Statement

Citations:

PubMed Identifier

25890643

Citation

Kinon BJ, Millen BA, Zhang L, McKinzie DL. Exploratory analysis for a targeted patient population responsive to the metabotropic glutamate 2/3 receptor agonist pomaglumetad methionil in schizophrenia. Biol Psychiatry. 2015 Dec 1;78(11):754-62. doi: 10.1016/j.biopsych.2015.03.016. Epub 2015 Mar 19.

Results Reference

derived

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A Study for Patients With Schizophrenia

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