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

Denovo Biopharma

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: aripiprazole; Drug: LY2140023; Drug: risperidone; Drug: olanzapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00845026

12648

H8Y-MC-HBBR (Other Identifier)

Details and patient eligibility

About

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.

Full 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)

Enrollment: 261 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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261 participants in 4 patient groups

LY2140023

Experimental group

Description:

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

Treatment:

Drug: LY2140023

aripiprazole

Active Comparator group

Description:

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

Treatment:

Drug: aripiprazole

olanzapine

Active Comparator group

Description:

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

Treatment:

Drug: olanzapine

risperidone

Active Comparator group

Description:

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

Treatment:

Drug: risperidone