A Study for Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00520923
First received: August 24, 2007
Last updated: October 16, 2009
Last verified: October 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Inpatient, Phase 2, Double-blind, Placebo-Controlled Dose Ranging Study of LY2140023 in Patients With DSM-IV Schizophrenia

Resource links provided by NLM:


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
Experimental: 1
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.
Other Name: LY2140023
Experimental: 2
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.
Other Name: LY2140023
Experimental: 3
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.
Other Name: LY2140023
Experimental: 4
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.
Other Name: LY2140023
Placebo Comparator: 5
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.
Active Comparator: 6
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00520923     History of Changes
Other Study ID Numbers: 11757, H8Y-MC-HBBI
Study First Received: August 24, 2007
Last Updated: October 16, 2009
Health Authority: Russia: Ministry of Health 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

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

ClinicalTrials.gov processed this record on September 18, 2014