A Long-Term Study in Schizophrenia

Phase 3

Terminated

Conditions: Schizophrenia

Interventions: Drug: Pomaglumetad methionil

Registration Number: NCT01487083

Lead Sponsor: Eli Lilly and Company

Brief Summary: The purpose of this study is to evaluate the long-term safety of pomaglumetad methionil in participants with schizophrenia.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 282

Inclusion Criteria

Participants are clinically diagnosed with 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
New participants must require initiation of or modification to current antipsychotic treatment, as indicated by their present clinical psychiatric status and/or treatment tolerability as outpatients. Criterion does not apply to participants rolling over from a feeder study (NCT01328093 and NCT01452919)
Participants must be considered reliable and 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

Are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an investigational product (IP) or nonapproved 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, except for participants who are rolling over from a feeder study (NCT01328093 and NCT01452919) who will have completed a clinical trial of pomaglumetad methionil
Have any other current psychiatric diagnoses in addition to schizophrenia
Have previously completed or withdrawn from this study, or any other study investigating pomaglumetad methionil or any predecessor molecules with glutamatergic activity, except for participants who are rolling over from a feeder study (NCT01328093 and NCT01452919) who will have completed a clinical trial of pomaglumetad methionil
Participants who have received an adequate treatment trial, in the opinion of the investigator, with clozapine at doses greater than 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 have a history of an inadequate clinical response to antipsychotic treatment for schizophrenia
Participants who, for any reason, are considered to be a danger to themselves, or who are actively exhibiting suicidal behaviors
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 with current or a history of seizure disorder, leucopenia, 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 of study entry or who will have ECT at any time during the study
Participants with known medical history of Human Immunodeficiency Virus (HIV) positive status
Participants who 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 msec (male) or >470 msec (female) at study entry

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pomaglumetad methionil	Pomaglumetad methionil	Pomaglumetad methionil will be administered orally. Participants entering the study will be flexibly dosed between 20 mg, 40 mg, and 80 mg twice daily.

Primary Outcome Measures

Name	Time	Method
Categorical change from baseline up to 5 years in Barnes Akathisia Scale (BAS)	Baseline, up to 5 years
Categorical change from baseline up to 5 years in Simpson-Angus Scale (SAS)	Baseline, up to 5 years
Categorical change from baseline up to 5 years in Abnormal Involuntary Movement Scale (AIMS)	Baseline, up to 5 years
Proportion of participants with clinically significant weight change from baseline up to 5 years	Baseline up to 5 years
Categorical change from baseline up to 5 years in prolactin level	Baseline, up to 5 years
Categorical change from baseline up to 5 years in fasting glucose and lipids	Baseline, up to 5 years

Secondary Outcome Measures

Name	Time	Method
Time to lack of efficacy	Baseline up to 5 years
Number of participants with suicidal behaviors and ideations measured by Columbia Suicide Severity Rating Scale (CSSRS)	Baseline up to 5 years
Change from baseline up to 5 years in Clinical Global Impressions-Severity (CGI-S)	Baseline, up to 5 years
Change from baseline up to 5 years in Brief Psychiatric Rater Scale (BPRS)	Baseline, up to 5 years

Trial Locations

Locations (1): 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.
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Malmo, Sweden