ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study for Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00520923
Recruitment Status : Completed
First Posted : August 27, 2007
Last Update Posted : October 19, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

Brief Summary:
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 or disease Intervention/treatment Phase
Schizophrenia Drug: LY2140023 Drug: Olanzapine Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 654 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : September 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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.

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.

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.

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.

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.




Primary Outcome Measures :
  1. Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: over 4 weeks of treatment ]

Secondary Outcome Measures :
  1. PANSS subscores: positive subscore; negative subscore; general psychopathology subscore and cognitive subscore [ Time Frame: over 4 weeks of treatment ]
  2. Clinical Global Impression-Severity (CGI-S) [ Time Frame: over 4 weeks of treatment ]
  3. Drug Attitude Inventory-10 (DAI-10) [ Time Frame: over 4 weeks of treatment ]
  4. Response and Remission Rates [ Time Frame: over 4 weeks of treatment ]
  5. Assessment of Cognition in Schizophrenia (BACS) Symbol Coding Task [ Time Frame: over 4 weeks of treatment ]
  6. Montgomery-Asberg Depression RatingScale (MADRS) [ Time Frame: over 4 weeks of treatment ]
  7. Safety and Tolerability [ Time Frame: over 4 weeks of treatment ]
  8. Pharmacokinetics [ Time Frame: over 4 weeks of treatment ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00520923     History of Changes
Other Study ID Numbers: 11757
H8Y-MC-HBBI
First Posted: August 27, 2007    Key Record Dates
Last Update Posted: October 19, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents