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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

654

participants targeted

Target at P75+ for phase_2 schizophrenia

Timeline

Completed

Started Sep 2007

Shorter than P25 for phase_2 schizophrenia

Geographic Reach

9 countries

35 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.1 years study duration

First Submitted

Initial submission to the registry

August 24, 2007

Completed

3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2007

Completed

5 days until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed

Last Updated

October 19, 2009

Status Verified

October 1, 2009

Enrollment Period

1.1 years

First QC Date

August 24, 2007

Last Update Submit

October 16, 2009

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

Positive and Negative Syndrome Scale (PANSS) total score
over 4 weeks of treatment

Secondary Outcomes (8)

PANSS subscores: positive subscore; negative subscore; general psychopathology subscore and cognitive subscore
over 4 weeks of treatment
Clinical Global Impression-Severity (CGI-S)
over 4 weeks of treatment
Drug Attitude Inventory-10 (DAI-10)
over 4 weeks of treatment
Response and Remission Rates
over 4 weeks of treatment
Assessment of Cognition in Schizophrenia (BACS) Symbol Coding Task
over 4 weeks of treatment
+3 more secondary outcomes

Study Arms (6)

1

EXPERIMENTAL

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

Drug: LY2140023

2

EXPERIMENTAL

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

Drug: LY2140023

3

EXPERIMENTAL

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

Drug: LY2140023

4

EXPERIMENTAL

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

Drug: LY2140023

5

PLACEBO COMPARATOR

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

Drug: Placebo

6

ACTIVE COMPARATOR

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

Drug: OlanzapineDrug: Placebo

Interventions

LY2140023DRUG

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

OlanzapineDRUG

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

PlaceboDRUG

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

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (35)

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, B1828CKR, Argentina

Location

Buenos Aires, C1424CAB, Argentina

Location

Lanús Este, B18241BR, Argentina

Location

Munro, 1605, Argentina

Location

Graz, 8036, Austria

Location

Vienna, 1090, Austria

Location

Osijek, HR-31000, Croatia

Location

Split, 21000, Croatia

Location

Zagreb, HR-10090, Croatia

Location

Aachen, D-52057, Germany

Location

Bochum, 44791, Germany

Location

Dresden, 01307, Germany

Location

München, D-81675, Germany

Location

Mexico City, 14420, Mexico

Location

Monterrey, 64000, Mexico

Location

Lisbon, 1350-190, Portugal

Location

Porto, 4200-272, Portugal

Location

Bucharest, 73120, Romania

Location

Craiova, 200738, Romania

Location

Iași, 700282, Romania

Location

Târgu Mureş, 540139, Romania

Location

Kazan', 420012, Russia

Location

Khot'kovo, 127025, Russia

Location

Lipetsk, 399007, Russia

Location

Moscow, 123367, Russia

Location

Nizhny Novgorod, 603155, Russia

Location

Saint Petersburg, 190121, Russia

Location

Samara, 443016, Russia

Location

Village Nikolskoe, 188357, Russia

Location

Bloemfontein, 9300, South Africa

Location

Cape Town, 7530, South Africa

Location

Durban, 4000, South Africa

Location

Johannesburg, 2198, South Africa

Location

Pretoria, 0181, South Africa

Location

Randburg, 2125, South Africa

Location

Related Publications (1)

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.
PMID: 25890643DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

LY 2140023Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

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
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

August 24, 2007

First Posted

August 27, 2007

Study Start

September 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

October 19, 2009

Record last verified: 2009-10

Locations

ZA(6)PT(2)AR(4)CR(3)RU(8)AU(2)ME(2)DE(4)RO(4)

A Study for Patients With Schizophrenia

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (6)

1

2

3

4

5

6

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (35)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (6)

1

2

3

4

5

6

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (35)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations