A Comparison Study of LY2140023 and Aripiprazole in Schizophrenia Patients

Denovo Biopharma

Status and phase: Terminated; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Aripiprazole; Drug: LY2140023

Study type: Interventional

Funder types: Industry

Identifiers

NCT01328093

14211

H8Y-MC-HBDE (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine whether weight gain will be significantly less in LY2140023 than aripiprazole in patients with schizophrenia.

Full description

The primary objective of this study was to test the hypothesis that mean weight gain, as assessed by change from baseline, would be statistically significantly less for flexibly dosed LY2140023 (20, 40, or 80 mg twice daily [BID]) than for flexibly dosed aripiprazole (10, 15, or 30 mg/day) in patients with schizophrenia after 24 weeks of double-blind treatment.

This was a multicenter, randomized, double-blind, Phase 3 study to assess the safety and efficacy of LY2140023 (flexibly dosed between 20 and 80 mg BID) in patients with schizophrenia. An active control, aripiprazole (flexibly dosed between 10 and 30 mg/day), was included for comparison.

Enrollment: 678 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of schizophrenia
• Female participants of childbearing age must test negative for pregnancy at screening and agree to use single, effective, medically acceptable method of birth control
• Participants must require initiation of or modification to current antipsychotic treatment as outpatients
• Participants 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
• Participants must be able to understand the nature of the study and have given their own informed consent

Exclusion criteria

• Have been on treatment with aripiprazole in the past 2 months or are aripiprazole nonresponders
• Participants who are pregnant, nursing, or intend to become pregnant within 30 days of completing the study
• Hospitalized within 2 weeks of screening or have been hospitalized for an exacerbation of symptoms of schizophrenia with a discharge date in the past 2 months
• Participants who are actively suicidal
• Participants with uncorrected narrow-angle glaucoma, history of or current seizure disorder, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, uncontrolled thyroid condition or other serious or unstable illnesses
• Participants who have had electroconvulsive therapy (ECT) within 3 months prior to screening or will have ECT at any time during the study
• Participants with known medical history of Human Immunodeficiency Virus positive (HIV+) status
• Test positive for (1) Hepatitis C virus antibody or (2) Hepatitis B surface antigen (HBsAg) with or without positive Hepatitis B core total antibody
• Participants with a corrected QT interval (Bazett's; QTcB)>450 milliseconds (msec) (male) or >470 msec (female) at screening
• Participants who have a history of inadequate clinical response to antipsychotic treatment for schizophrenia
• Participants who have received treatment with any depot formulation of an antipsychotic medication within 1 dosing interval, minimum of 4 weeks, prior to screening
• Are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an investigational product or unapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
• Have any other psychiatric diagnoses in addition to schizophrenia
• Have previously completed or withdrawn from this study, or any other study investigating LY2140023 or any predecessor molecules with glutamatergic activity
• Participants who have received an adequate treatment trial, in the opinion of the investigator, with clozapine at doses greater than 200 milligrams (mg) daily within 12 months prior to screening, or who have received any clozapine at all during the month before screening
• Diagnosis of substance-induced psychosis within 7 days of screening (or at any time during the study)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

678 participants in 2 patient groups

LY2140023

Experimental group

Description:

Double Blind Phase: 40 milligrams (mg) administered orally, given twice daily for 24 weeks. Dose may be adjusted to a minimum of 20 mg or a maximum of 80 mg. Open Label Phase: 40 mg administered orally, given twice daily for an additional 28 weeks.

Treatment:

Drug: LY2140023

Aripiprazole

Active Comparator group

Description:

Double Blind Phase: 15 mg administered orally, given once daily for 24 weeks. Dose can be adjusted to a minimum of 10 mg or a maximum of 30 mg. Open Label Phase: LY2140023, 40 mg administered orally, given twice daily for an additional 28 weeks.

Treatment:

Drug: LY2140023

Drug: Aripiprazole