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A Study of LY2140023 in Schizophrenia Patients With Prominent Negative Symptoms | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of LY2140023 in Schizophrenia Patients With Prominent Negative Symptoms

A 17-Week, Phase 2, Multicenter, Randomized, Double-Blind Study of Treatment With LY2140023 Combined With Standard of Care (SOC) Compared to Placebo With SOC in the Treatment of Patients With Prominent Negative Symptoms of Schizophrenia

NCT01052103•Denovo Biopharma LLC

View on ClinicalTrials.gov

Summary

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

Detailed Description

The primary objective of this study was to test the hypothesis that treatment with LY2140023 compared to placebo, when added to a fixed dose of a standard of care (SOC) antipsychotic, would demonstrate significantly greater reduction of negative symptoms, as assessed by the 16-item Negative Symptom Assessment scale (NSA-16), in patients with schizophrenia. Patients included in this study were concurrently receiving 1 of 4 second generation antipsychotics (SGAs): aripiprazole, olanzapine, risperidone, or quetiapine.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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

Locations (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, United States

Chicago, Illinois, United States

Hoffman Estates, Illinois, United States

New York, New York, United States

Jerusalem, Israel

Parma, Italy

Torino, Italy

Barcelona, Spain

Zamora, Spain

Key Dates

Start Date

January 1, 2010

Primary Completion Date

June 1, 2012

Completion Date

June 1, 2012

Last Updated

September 7, 2022

Enrollment

167

ACTUAL participants

Conditions

Schizophrenia

Interventions

LY2140023

DRUG

Placebo

DRUG

Standard of Care

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 7, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of LY2140023 in Schizophrenia Patients With Prominent Negative Symptoms

Inclusion Criteria

Exclusion Criteria

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

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