A Long-Term Study in Schizophrenia



Status:Completed
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:December 2011
End Date:October 2012
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone:1-317-615-4559

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Long-Term Open-Label Safety Study of Pomaglumetad Methionil in Patients With Schizophrenia


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


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- Have previously completed or withdrawn from this study, or any other study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
We found this trial at
18
sites
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Miami, FL
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Alexandria, LA
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Bridgewater, NJ
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Brooklyn, NY
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Chapel Hill, North Carolina 27599
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Chicago, IL
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Fort Worth, TX
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Indianapolis, IN
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Kansas City, MO
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Los Angeles, CA
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Muskogee, OK
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Norfolk, VA
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Philadelphia, Pennsylvania 19107
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Philadelphia, PA
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Picayune, MS
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Portland, OR
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Seattle, WA
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Washington, District of Columbia 20010
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Washington,
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