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A Study for Patients With Schizophrenia
This study has been completed.
First Received: August 24, 2007   Last Updated: October 22, 2008   History of Changes
Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00520923
  Purpose

The purpose of this study is to test the hypothesis that 1 or more dose levels of LY2140023 given orally to patients with schizophrenia twice daily for 4 weeks will have significantly greater effect than placebo.


Condition Intervention Phase
Schizophrenia
Drug: LY2140023
Drug: Olanzapine
Drug: Placebo
Phase II

MedlinePlus related topics: Schizophrenia
Drug Information available for: Olanzapine LY2140023
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A Multi-Center, Inpatient, Phase 2, Double-Blind, Placebo-Controlled Dose Ranging Study of LY2140023 in Patients With DSM-IV Schizophrenia

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: over 4 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PANSS subscores: positive subscore; negative subscore; general psychopathology subscore and cognitive subscore [ Time Frame: over 4 weeks of treatment ] [ Designated as safety issue: No ]
  • Clinical Global Impression-Severity (CGI-S) [ Time Frame: over 4 weeks of treatment ] [ Designated as safety issue: No ]
  • Drug Attitude Inventory-10 (DAI-10) [ Time Frame: over 4 weeks of treatment ] [ Designated as safety issue: No ]
  • Response and Remission Rates [ Time Frame: over 4 weeks of treatment ] [ Designated as safety issue: No ]
  • Assessment of Cognition in Schizophrenia (BACS) Symbol Coding Task [ Time Frame: over 4 weeks of treatment ] [ Designated as safety issue: No ]
  • Montgomery-Asberg Depression RatingScale (MADRS) [ Time Frame: over 4 weeks of treatment ] [ Designated as safety issue: No ]
  • Safety and Tolerability [ Time Frame: over 4 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: over 4 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 654
Study Start Date: September 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
160mg of LY2140023, taken orally as 80mg twice daily, for up to 4 weeks.
Drug: LY2140023
80mg, PO (by mouth) BID (twice a day) for up to 4 weeks.
2: Experimental
80mg of LY2140023, taken orally as 40mg twice daily, for up to 4 weeks.
Drug: LY2140023
40mg, PO (by mouth) BID (twice daily) for up to 4 weeks.
3: Experimental
40mg of LY2140023, taken orally as 20mg twice daily, for up to 4 weeks.
Drug: LY2140023
20mg, PO (by mouth) BID (twice daily) for up to 4 weeks.
4: Experimental
10mg of LY2140023, taken orally as 5mg twice daily, for up to 4 weeks.
Drug: LY2140023
5mg, PO (by mouth) BID (twice daily) for up to 4 weeks.
5: Placebo Comparator
Placebo of LY2140023, taken orally twice daily, for up to 4 weeks.
Drug: Placebo
Taken PO (by mouth) BID (twice daily) for up to 4 weeks.
6: Active Comparator
Placebo, taken orally every morning, followed by Olanzapine 15mg taken orally every evening for up to 4 weeks.
Drug: Olanzapine
10mg, PO (by mouth) QPM (every evening) for the first 3 days, then 15mg PO QPM, for up to 4 weeks.
Drug: Placebo
Taken PO (by mouth) QAM (every morning) for up to 4 weeks.

  Eligibility

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

Some Inclusion Criteria:

  • Patients must have a diagnosis of Schizophrenia as defined in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (Disorganized, 295.10; Catatonic, 295.20; Paranoid, 295.30; Residual, 295.60; or Undifferentiated, 295.90) and confirmed by the Structured Clinical Interview for DSM-IV (SCID).
  • Patients must meet the following psychopathologic severity criteria at Visit 1: Brief Psychiatric Rating Scale (BPRS) total score, extracted from the Positive and Negative Syndrome Scale (PANSS), of at least 45 (18-item version, in which 1 indicates "absent" and 7 indicates "severe"). In addition, item scores of at least 4 (moderate) will be required on 2 of the following BPRS items: conceptual disorganization, suspiciousness, hallucinatory behavior, and/or unusual thought content.
  • Patients must receive a rating of 4 (moderately ill) or greater on the Clinical Global Impression-Severity (CGI-S) scale at Visit 1.
  • Patients in whom, in the opinion of the investigator, a switch to another antipsychotic medication or initiation of an antipsychotic medication is acutely indicated.

Some Exclusion Criteria:

  • Patients in whom treatment with olanzapine or placebo is relatively or absolutely clinically contraindicated.
  • Patients who have a history of inadequate response to an adequate treatment trial with olanzapine, in the opinion of the investigator.
  • Patients who have received treatment with olanzapine within 6 weeks prior to Visit 1.
  • Patients who have received treatment with clozapine at doses greater than 200 mg daily within 12 months prior to Visit 1, or who have received any clozapine at all during the month before Visit 1.
  • Patients who have a history of an inadequate response, in the opinion of the investigator, to 2 or more adequate antipsychotic medication trials of at least 8 weeks duration in the past 12 months prior to Visit 1.
  • Patients with acute, serious, or unstable medical conditions, including (but not limited to) inadequately controlled diabetes (hemoglobin A1c (HbA1c) 8%), severe hypertriglyceridemia (fasting triglycerides 5.6 mmol/L, recent cerebrovascular accidents, serious acute systemic infection or immunologic disease, unstable cardiovascular disorders (including ischemic heart disease), malnutrition, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, or hematologic diseases.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520923

  Show 35 Study Locations
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 - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
No publications provided

Responsible Party: Eli Lilly ( Chief Medical Officer )
Study ID Numbers: 11757, H8Y-MC-HBBI
Study First Received: August 24, 2007
Last Updated: October 22, 2008
ClinicalTrials.gov Identifier: NCT00520923     History of Changes
Health Authority: Russia: Ministry of Health and Social Development of the Russian Federation;   Mexico: Ministry of Health;   South Africa: Medicines Control Council;   Croatia: Ministry of Health and Social Care;   Portugal: National Pharmacy and Medicines Institute;   Austria: Ethikkommission;   Germany: Federal Institute for Drugs and Medical Devices;   Romania: National Medicines Agency;   Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study placed in the following topic categories:
Neurotransmitter Agents
Tranquilizing Agents
Olanzapine
Psychotropic Drugs
Central Nervous System Depressants
Antiemetics
Antipsychotic Agents
Serotonin Uptake Inhibitors
Serotonin
Schizophrenia
Mental Disorders
Psychotic Disorders
Peripheral Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Olanzapine
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Schizophrenia
Serotonin Agents
Autonomic Agents
Mental Disorders
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009