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A Study of LY2140023 in Schizophrenia Patients With Prominent Negative Symptoms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01052103
First received: January 13, 2010
Last updated: September 18, 2012
Last verified: July 2012

January 13, 2010
September 18, 2012
January 2010
June 2012   (final data collection date for primary outcome measure)
Change from baseline in the 16-item Negative Symptoms Assessment (NSA-16) [ Time Frame: Baseline, 16 or 17 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01052103 on ClinicalTrials.gov Archive Site
  • Change from baseline in Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline, 16 or 17 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Clinical Global Impression Severity Scale (CGI-S) [ Time Frame: Baseline, 16 or 17 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB) [ Time Frame: Baseline, 17 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in University of California at San Diego Performance-Based Skills Assessment-Brief Version (UPSA-B) [ Time Frame: Baseline, 17 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Barnes-Akathisia Scale [ Time Frame: Baseline, 16 or 17 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of epileptiform activity in Electroencephalograms (EEGs) [ Time Frame: Up to 19 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of potentially clinically significant changes in QT intervals Electrocardiograms (ECGs) [ Time Frame: Up to 17 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of change in Neurological Examination [ Time Frame: Up to 17 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in blood pressure [ Time Frame: Baseline, 16 or 17 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in weight [ Time Frame: Baseline, 16 or 17 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of potentially clinical significant change in laboratory values [ Time Frame: Up to 17 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of potentially clinical significant change of Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to 17 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 17 weeks endpoint in Personal and Social Performance (PSP) Scale [ Time Frame: Baseline, 17 weeks ] [ Designated as safety issue: No ]
  • Time to discontinuation [ Time Frame: Up to 17 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Simpson Angus Scale [ Time Frame: Baseline, 16 or 17 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline, 16 or 17 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in pulse rate [ Time Frame: Baseline, 16 or 17 weeks ] [ Designated as safety issue: Yes ]
  • Change from 1 week to 18 weeks endpoint in the Schizophrenia Resource Use Module (S-RUM) [ Time Frame: 1 week, 18 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 17 weeks endpoint in the EuroQol Questionnaire-5 Dimension (EQ-5D) [ Time Frame: baseline, 17 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 17 weeks endpoint in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) [ Time Frame: baseline, 17 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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 Compared to Placebo Combined With Standard of Care in the Treatment of Patients With Prominent Negative Symptoms of Schizophrenia

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: LY2140023
    40mg, 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 20mg or a maximum of 80mg.
  • Drug: Placebo
    Placebo oral tablets, twice daily: in the morning and in the evening, for 16 or 17 weeks.
  • Drug: Standard of Care
    U.S. label prescribed dose of one of the following Standard of Care Antipsychotics (aripiprazole, olanzapine, risperidone, quetiapine)
    Other Names:
    • Zyprexa
    • LY170053
  • Experimental: LY2140023
    Interventions:
    • Drug: LY2140023
    • Drug: Standard of Care
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Placebo
    • Drug: Standard of Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of schizophrenia
  • Patients 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
  • Patients must have evidence of prominent negative symptoms of schizophrenia (i.e. blunted affect, emotional withdrawal, or motor retardation)
  • Patients 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
  • Patients must be able to understand the nature of the study and have given their informed consent

Exclusion Criteria:

  • Patients who are actively suicidal
  • Patients who are pregnant or nursing
  • Patients who have had electroconvulsive therapy (ECT) within 3 months of screening or who will have ECT at any time during the study
  • Patients 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
  • Patients with Parkinson's disease, psychosis related to dementia or related disorders
  • Patients with known Human Immunodeficiency Virus positive (HIV+) status
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Israel,   Italy,   Spain
 
NCT01052103
13261, H8Y-MC-HBCO
Yes
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: 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
Eli Lilly and Company
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP