A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients

NCT ID: NCT00845026

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 261 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-12-31

Brief Summary

The primary objective of this study was to 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 (SOC) treatment. Lack of tolerability was defined as discontinuation due to adverse events (AEs).

Patients who completed the active treatment phase were eligible to continue to an optional 28 weeks of treatment extension phase. This extension phase assessed key safety and efficacy measures.

Detailed Description

A Phase 2, multicenter, randomized, parallel, open-label study comparing the long-term safety and tolerability of LY2140023 with atypical antipsychotic agents considered to be the current SOC for patients with schizophrenia. The study included a 24-week active treatment phase and an optional 28-week active treatment extension phase.

The time to discontinuation due to AEs during Study Period III (24-week active treatment phase) was compared between LY2140023 and standard of care using the log-rank test from the Kaplan-Meier survival analysis. Patients who completed Study Period III or who discontinued for a reason other than AEs were considered as censored observations.

Secondary objectives were assessed during both Study Period III [Active Treatment Phase] and Study Period IV [Active Treatment Extension Phase]) except for treatment-emergent adverse events (TEAEs), extrapyramidal symptoms (EPS), electroencephalograms (EEGs), electrocardiograms (ECGs) (analysis for Study Period III only) (indicated in "Time Frame" in "Results" section)

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

LY2140023

LY2140023 (80 mg/day), given orally twice daily as two 40-mg tablets for 24 weeks

Group Type: EXPERIMENTAL

LY2140023

Intervention Type: DRUG

80 milligram (mg), 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 40 mg or a maximum of 160 mg.

aripiprazole

aripiprazole (20 mg/day), given orally once daily for 24 weeks

Group Type: ACTIVE_COMPARATOR

aripiprazole

Intervention Type: DRUG

10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).

olanzapine

olanzapine (15 mg/day), given orally once daily for 24 weeks

Group Type: ACTIVE_COMPARATOR

olanzapine

Intervention Type: DRUG

10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).

risperidone

risperidone (4 mg/day), given orally, once or BID for 24 weeks

Group Type: ACTIVE_COMPARATOR

risperidone

Intervention Type: DRUG

2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).

Interventions

LY2140023

80 milligram (mg), 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 40 mg or a maximum of 160 mg.

Intervention Type: DRUG

aripiprazole

10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).

Intervention Type: DRUG

olanzapine

10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).

Intervention Type: DRUG

risperidone

2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).

Intervention Type: DRUG

Other Intervention Names

pomaglumetad methionil; Abilify; Zyprexa; Risperdal

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Denovo Biopharma LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Escondido, California, United States

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Garden Grove, California, United States

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Washington D.C., District of Columbia, United States

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Chicago, Illinois, United States

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Hoffman Estates, Illinois, United States

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Indianapolis, Indiana, United States

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Lake Charles, Louisiana, United States

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Willingboro, New Jersey, United States

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Amityville, New York, United States

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Oklahoma City, Oklahoma, United States

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DeSoto, Texas, United States

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Jena, , Germany

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Mannheim, , Germany

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Wiesbaden, , Germany

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Guadalajara, , Mexico

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Mexico City, , Mexico

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Monterrey, , Mexico

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Khot'kovo, , Russia

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Lipetsk, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Saint Petersburg, , Russia

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Samara, , Russia

Countries

United States; Germany; Mexico; Russia

Other Identifiers

H8Y-MC-HBBR

Identifier Type: OTHER

Identifier Source: secondary_id

12648

Identifier Type: -

Identifier Source: org_study_id