NCT00149292

Brief Summary

Assess the efficacy of a new drug (a receptor agonist that modulates the glutamatergic activity) in the treatment of schizophrenia. The primary objective of this study is to determine if a mGlu2/3 agonist dosed for 28 days is superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Symptom Scales (PANSS) total score.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
195

participants targeted

Target at P50-P75 for phase_2 schizophrenia

Timeline
Completed

Started Aug 2005

Shorter than P25 for phase_2 schizophrenia

Geographic Reach
1 country

2 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

August 23, 2005

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2006

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

11 months

First QC Date

September 2, 2005

Last Update Submit

August 16, 2021

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • To determine if a mGlu2/3 agonist (LY2140023) dosed for 28 days is superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Symptom Scales (PANSS) total score

    The primary objective of this study was to determine if LY2140023 dosed at 40 mg twice daily (BID) for 28 days was superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Symptom Scale (PANSS) total score.

    28 days

Secondary Outcomes (4)

  • Safety and tolerability of LY2140023 compared with placebo and olanzapine

    28 days

  • Efficacy of LY2140023 compared with placebo in change from baseline to Visit 8 in the PANSS positive symptom subset score

    28 days

  • Efficacy of LY2140023 compared with placebo in the responder rate in the PANSS total score

    28 days

  • Efficacy of LY2140023 compared with placebo in responder rate in the PANSS positive and negative symptom subset score

    28 days

Study Arms (3)

LY2140023

EXPERIMENTAL

40 mg LY2140023 BID for 28 days

Drug: LY2140023

Olanzapine

ACTIVE COMPARATOR

15 mg Olanzapine once daily (QD) for 28 days

Drug: olanzapine

Placebo

PLACEBO COMPARATOR

placebo for 28 days

Drug: placebo

Interventions

LY2140023DRUG
LY2140023
olanzapineDRUG
Olanzapine
placeboDRUG
Placebo

Eligibility Criteria

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

You may qualify if:

  • meet the DSM-IV criteria for schizophrenia as confirmed by modified SCID

You may not qualify if:

  • meet the full syndromal criteria for other Axis I disorder
  • have taken any depot antipsychotic within 4 weeks before screening
  • are taking mood-stabilizing agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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.

Moscow, Russia

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.

Village Nikolskoe, Russia

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-5PM 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
Masking Details
Investigators and patients were blinded to each patient's treatment. Only a pharmacist or designated person at the study site were unblinded to each patient's treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 8, 2005

Study Start

August 23, 2005

Primary Completion

July 17, 2006

Study Completion

July 17, 2006

Last Updated

August 20, 2021

Record last verified: 2021-08

Locations

RU(2)