NCT01052103

Brief Summary

The purpose of this study is to determine whether LY2140023, when added to standard-of-care antipsychotic treatment, will improve negative symptoms.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
167

participants targeted

Target at P50-P75 for phase_2 schizophrenia

Timeline
Completed

Started Jan 2010

Typical duration for phase_2 schizophrenia

Geographic Reach
4 countries

9 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

Study Start

First participant enrolled

January 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 20, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
9.3 years until next milestone

Results Posted

Study results publicly available

September 22, 2021

Completed
Last Updated

September 7, 2022

Status Verified

August 1, 2022

Enrollment Period

2.4 years

First QC Date

January 13, 2010

Results QC Date

August 25, 2021

Last Update Submit

August 10, 2022

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in the 16-Item Negative Symptoms Assessment (NSA-16)

    The NSA-16 scale is used to help clinicians rate behaviors (not psychopathology) commonly associated with negative symptoms of schizophrenia. The scale rates participants on 16 "anchors". Each item ("anchor") is rated from 1 (better) to 6 (worse). The total score is the sum of the 16 specific items and ranges from 16 to 96. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measure (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values are controlled for visit, pooled investigative site, treatment, standard of care (SOC) type, baseline positive symptom stratum, treatment\*visit, baseline NSA-16 total score, and baseline NSA-16 total score\*visit.

    Baseline, randomization treatment Week 16

Secondary Outcomes (24)

  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score

    Baseline, randomization treatment Week 16

  • Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale

    Baseline, randomization treatment Week 16

  • Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB) Overall Composite T-Score

    Baseline, randomization treatment Week 16

  • Change From Baseline in University of California at San Diego Performance-Based Skills Assessment-Brief Version (UPSA-B) Total Score

    Baseline, randomization treatment Week 16

  • Change From Baseline in Barnes-Akathisia Scale (BAS) Global Score

    Baseline, randomization treatment Week 16

  • +19 more secondary outcomes

Study Arms (2)

LY2140023

EXPERIMENTAL

40 mg/day, given orally twice daily (BID) as a 20-mg tablet. LY2140023 dosage was adjustable from 10 mg to 40 mg BID.

Drug: LY2140023Drug: Standard of Care

Placebo

PLACEBO COMPARATOR

Placebo tablets to match LY2140023 tablets

Drug: PlaceboDrug: Standard of Care

Interventions

LY2140023DRUG

40 milligrams (mg), oral tablets, twice daily: 20 mg in the morning, 20 mg in the evening, for 16 or 17 weeks. The dose may be adjusted to a minimum of 20 mg or a maximum of 80 mg.

Also known as: pomaglumetad methionil
LY2140023
PlaceboDRUG

Placebo oral tablets, twice daily: in the morning and in the evening, for 16 or 17 weeks.

Placebo
Standard of CareDRUG

United States (U.S.) label prescribed dose of one of the following Standard of Care Antipsychotics (aripiprazole, olanzapine, risperidone, quetiapine)

LY2140023Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of schizophrenia
  • Participants must have been receiving monotherapy treatment for at least 3 months prior to study entry with one of 4 atypical antipsychotic medications (aripiprazole, olanzapine, risperidone, quetiapine)
  • Disease symptoms must meet a certain range as assessed by the clinician
  • Participants must have evidence of prominent negative symptoms of schizophrenia (for example blunted affect, emotional withdrawal, or motor retardation)
  • Participants must be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures
  • Participants must be able to understand the nature of the study and have given their informed consent

You may not qualify if:

  • Participants who are actively suicidal
  • Participants who are pregnant or nursing
  • Participants who have had electroconvulsive therapy (ECT) within 3 months of screening or who will have ECT at any time during the study
  • Participants with uncorrected narrow-angle glaucoma, history of or current seizure disorder, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, uncontrolled thyroid condition or other serious or unstable illnesses
  • Participants with Parkinson's disease, psychosis related to dementia or related disorders
  • Participants with known Human Immunodeficiency Virus positive (HIV+) status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

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.

Garden Grove, California, 92845, United States

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.

Chicago, Illinois, 60640, United States

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.

Hoffman Estates, Illinois, 60169, United States

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.

New York, New York, 10035, United States

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.

Jerusalem, 91060, Israel

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.

Parma, 43100, Italy

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.

Torino, 10126, Italy

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.

Barcelona, 08036, Spain

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.

Zamora, 49021, Spain

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

LY 2140023pomaglumetad methionilStandard of Care

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

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

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2010

First Posted

January 20, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

September 7, 2022

Results First Posted

September 22, 2021

Record last verified: 2022-08

Locations

IL(1)IT(2)ES(2)US(4)