A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients
Tracking InformationStart Date ICMJE | April 2009 |
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Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) |
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Current Primary Outcome Measures ICMJE (submitted: March 23, 2009) | Time to discontinuation. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ] |
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Original Primary Outcome Measures ICMJE (submitted: February 13, 2009) | Time to discontinuation. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] |
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Change History | Complete list of historical versions of study NCT00845026 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE (submitted: March 23, 2009) | - Extrapyramidal symptoms (EPS) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- Electroencephalograms (EEGs) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- Electrocardiograms (ECGs). [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- Neurological examination. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- Changes in vitals signs. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- Changes in weight [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- Changes in laboratory values [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- Positive and Negative Syndrome Scale (PANSS). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Clinical Global Impression Severity Scale (CGI-S) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- 16-item Negative Symptoms Assessment (NSA-16). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- MATRICS Consensus Cognitive Battery (MCCB). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Montgomery-Asberg Depression Rating Scale (MADRS). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Health outcome as measured by quality of life, functioning, resource utilization, and patient-reported outcomes compared to standard of care. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Rate of response [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Rate of remission [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Rate of relapse [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
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Original Secondary Outcome Measures ICMJE (submitted: February 13, 2009) | - Extrapyramidal symptoms (EPS) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- Electroencephalograms (EEGs) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- Electrocardiograms (ECGs). [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- Neurological examination. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- Changes in vitals signs. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- Changes in weight [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- Changes in laboratory values [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- Positive and Negative Syndrome Scale (PANSS). [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- Clinical Global Impression Severity Scale (CGI-S) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- 16-item Negative Symptoms Assessment (NSA-16). [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- MATRICS Consensus Cognitive Battery (MCCB). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Montgomery-Asberg Depression Rating Scale (MADRS). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Health outcome as measured by quality of life, functioning, resource utilization, and patient-reported outcomes compared to standard of care. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Rate of response [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Rate of remission [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Rate of relapse [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
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Descriptive InformationBrief Title ICMJE | A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients. |
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Official Title ICMJE | A Long-Term, Phase 2, Multicenter, Randomized, Open-Label Comparative Safety Study of LY2140023 Versus Atypical Antipsychotic Standard of Care in Patients With DSM-IV-TR Schizophrenia. |
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Brief Summary | This study will assess time to discontinuation due to lack of tolerability among patients with schizophrenia receiving LY2140023, given orally twice daily for 24 weeks, versus those on atypical antipsychotic standard-of-care treatment. Lack of tolerability is defined as discontinuation due to adverse events (AEs). |
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Detailed Description | |
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Study Phase | Phase II |
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Study Type ICMJE | Interventional |
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Study Design ICMJE | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety Study |
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Condition ICMJE | Schizophrenia |
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Intervention ICMJE | - Drug: LY2140023
80mg, oral tablets,twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40mg or a maximum of 160mg. - Drug: aripiprazole
10mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20mg, 2-10mg oral tablets,once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10mg or a maximum of 30mg (3-10mg oral tablets). - Drug: olanzapine
10mg dose (2-5mg oral tablets) once every evening, for 3 days. Followed by an increase to 15mg (3-5mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10mg or a maximum of 20mg (4-5mg oral tablets). - Drug: risperidone
2mg dose, 2-1mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4mg (4-1mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2mg/day or a maximum of 6mg/day (6-1mg tablets).
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Study Arms / Comparison Groups | - LY2140023: Experimental
Intervention: Drug: LY2140023 - aripiprazole: Active Comparator
Intervention: Drug: aripiprazole - olanzapine: Active Comparator
Intervention: Drug: olanzapine - risperidone: Active Comparator
Intervention: Drug: risperidone
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Recruitment InformationEstimated Enrollment ICMJE | 260 |
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Estimated Completion Date | June 2010 |
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Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) |
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Eligibility Criteria ICMJE | Inclusion Criteria: - Clinical diagnosis of schizophrenia
- Patients, in the investigator's opinion, must require a switch to another antipsychotic medication as clinically indicated or initiation of an antipsychotic agent
- Patients must be willing and able to be hospitalized, or to remain hospitalized (if already hospitalized), for up to 17 days
- The investigator expects, at the time of enrollment, that the patient will be able to be discharged from the hospital after the first 2 weeks of active treatment
- Disease symptoms must meet a certain range as assessed by the clinician
- Patients must have evidence of functional impairment (i.e. social or vocational deficiency)
- Patients must be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures
- Patients must be able to understand the nature of the study and have given their informed consent
Exclusion Criteria: - Patients who are actively suicidal
- Patients who are pregnant or nursing
- Patients who have had electroconvulsive therapy (ECT) within 3 months of screening or who will have ECT at any time during the study
- Patients with uncorrected narrow-angle glaucoma, seizures, uncontrolled diabetes, certain diseases of the liver, uncontrolled thyroid condition or other serious or unstable illnesses
- Patients with Parkinson's disease, psychosis related to dementia or related disorders
- Patients with known Human Immunodeficiency Virus positive (HIV+) status
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Gender | Both |
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Ages | 18 Years to 65 Years |
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Accepts Healthy Volunteers | No |
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Contacts ICMJE | Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 | | |
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Location Countries ICMJE | United States, Germany, Mexico, Russian Federation |
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Administrative InformationNCT ID ICMJE | NCT00845026 |
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Responsible Party | Chief Medical Officer, Eli Lilly |
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Study ID Numbers ICMJE | 12648, H8Y-MC-HBBR |
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Study Sponsor ICMJE | Eli Lilly and Company |
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Collaborators ICMJE | |
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Investigators ICMJE | 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 | |
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Information Provided By | Eli Lilly and Company |
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