A Study for Patients With Schizophrenia
This study has been completed.
Sponsor:
Eli Lilly and Company
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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520923
Show 35 Study Locations
Show 35 Study LocationsSponsors 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 Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on June 18, 2013