A Physical Dependence Study in Schizophrenia

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether or not people with schizophrenia who take LY2140023 become physically dependent on it, and experience a series of symptoms such as craving to have the drug when they stop using it.

This trial consists of two phases: An open-label phase consisting of up to 4 weeks and a double-blind phase consisting of up to 3 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Denovo Biopharma LLC; Eli Lilly and Company

Criteria

Inclusion Criteria:

• Clinical diagnosis of schizophrenia

• Female participants of childbearing potential must test negative for pregnancy at study entry and agree to use a single, effective, medically acceptable method of birth control

• Participants must require a modification of antipsychotic medication or the initiation of antipsychotic medication, as indicated by their present clinical psychiatric status and/or treatment tolerability as outpatients

• Participants must be considered reliable and have a level of understanding sufficient to perform all tests and examinations required, 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 a Clinical Global Impression-Severity Scale (CGI-S) score >4 at study entry

• Have any other psychiatric diagnoses in addition to schizophrenia

• Participants who have a history of inadequate clinical response to antipsychotic treatment for schizophrenia

• Participants who have received an adequate treatment trial, in the opinion of the investigator, with clozapine at doses >200 mg daily within 12 months prior to study entry, or who have received any clozapine at all during the month before study entry

• Participants who are actively suicidal

• Female participants who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study

• Have known, uncorrected, narrow-angle glaucoma

• Participants who have had electroconvulsive therapy (ECT) within 3 months of study entry or who will have ECT at any time during the study

• Participants with known medical history of human immunodeficiency virus positive (HIV+) status

• Participants who test positive for Hepatitis C virus antibody or Hepatitis B surface antigen (HBsAg) with or without positive Hepatitis B core total antibody

• Participants with current or a history of seizure disorder, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, uncontrolled thyroid condition or other serious or unstable illnesses

• Participants with a corrected QT interval (Bazett's; QTcB) >450 milliseconds (msec) (male) or >470 msec (female) at study entry (based on the central vendor's electrocardiogram [ECG] overread)

• Have previously completed or withdrawn from this study, or any other study investigating LY2140023 or any predecessor molecules with glutamatergic activity

• Are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an investigational product for 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