Study of LY2140023 in Schizophrenia - Full Text View

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: LY2140023 Drug: olanzapine Drug: placebo	Phase II

MedlinePlus related topics:

Schizophrenia

ChemIDplus related topics:

Olanzapine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Randomized, Double-Blind Comparison of LY2140023, Olanzapine, and Placebo in the Treatment of Patients With Schizophrenia

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Safety and tolerability of compared with placebo and olanzapine
Efficacy of LY2140023 compared with placebo in change from baseline to Visit 8 in the PANSS positive symptom subset score
Efficacy of LY2140023 compared with placebo in the responder rate (defined as 25% or more decrease from baseline to Visit 8) in the PANSS total score
Efficacy of LY2140023 compared with placebo in responder rate (defined as 25% or more decrease from baseline to Visit 8) in the PANSS positive and negative symptom subset score

Estimated Enrollment:	250
Study Start Date:	August 2005
Estimated Study Completion Date:	July 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149292

Locations


Russian Federation
	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, Russian Federation
	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, Russian Federation

Sponsors and Collaborators

Eli Lilly and Company

Investigators


Study Director:	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

More Information

Study ID Numbers:	9777, H8Y-BD-HBBD
First Received:	September 2, 2005
Last Updated:	July 31, 2006
ClinicalTrials.gov Identifier:	NCT00149292
Health Authority:	Russia: Pharmacological Committee, Ministry of Health

Study placed in the following topic categories:

Schizophrenia

Mental Disorders

Olanzapine

Psychotic Disorders

Serotonin

Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Gastrointestinal Agents

Psychotropic Drugs

Antiemetics

Central Nervous System Depressants

Antipsychotic Agents

Serotonin Uptake Inhibitors

Pharmacologic Actions

Serotonin Agents

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 14, 2008

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00149292