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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00520923 |
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 |
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Schizophrenia |
Drug: LY2140023 Drug: Olanzapine Drug: Placebo |
Phase II |
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 |
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 |
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1: Experimental
160mg of LY2140023, taken orally as 80mg twice daily, for up to 4 weeks.
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Drug: LY2140023
80mg, PO (by mouth) BID (twice a day) for up to 4 weeks.
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2: Experimental
80mg of LY2140023, taken orally as 40mg twice daily, for up to 4 weeks.
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Drug: LY2140023
40mg, PO (by mouth) BID (twice daily) for up to 4 weeks.
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3: Experimental
40mg of LY2140023, taken orally as 20mg twice daily, for up to 4 weeks.
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Drug: LY2140023
20mg, PO (by mouth) BID (twice daily) for up to 4 weeks.
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4: Experimental
10mg of LY2140023, taken orally as 5mg twice daily, for up to 4 weeks.
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Drug: LY2140023
5mg, PO (by mouth) BID (twice daily) for up to 4 weeks.
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5: Placebo Comparator
Placebo of LY2140023, taken orally twice daily, for up to 4 weeks.
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Drug: Placebo
Taken PO (by mouth) BID (twice daily) for up to 4 weeks.
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6: Active Comparator
Placebo, taken orally every morning, followed by Olanzapine 15mg taken orally every evening for up to 4 weeks.
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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.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Some Inclusion Criteria:
Some Exclusion Criteria:
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 |
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 |
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 |
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 |