A Long-Term Study in Schizophrenia

• Conditions: Schizophrenia; MedDRA version: 14.1Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2011-004327-13-GR
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-27
• Last Update Posted: 25 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

•Patients are male or female, 18 to 65 years of age (inclusive) at study entry with a diagnosis of schizophrenia as defined in the DSM-IV-TR (APA 2000) (Disorganized, 295.10; Catatonic, 295.20; Paranoid 295.30; Residual 295.60; or Undifferentiated, 295.90) and confirmed by the SCID. Patients who roll over from a feeder study are 18 to 65 years of age (inclusive) at time of entry into the feeder study, and no confirmatory diagnostic scale is needed.
•Female patients of childbearing potential must test negative for pregnancy at Visit 1 and agree to use a single, effective, medically acceptable method of birth control.
•In the opinion of the investigator, at Visit 1, new patients 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 patients rolling over from a feeder study.
•Patients 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.
•Patients must be able to understand the nature of the study and have given their own informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 282
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an 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 patients who are rolling over from a feeder study who will have completed a clinical trial of Pomaglumetad Methionil.
•Are investigator site personnel directly affiliated with this study and/or their immediate families.
•Are Lilly employees.
•Are hospitalized within 2 weeks of Visit 1 or have been hospitalized for an exacerbation of symptoms of schizophrenia with a discharge date in the past 2 months. For patients rolling over from a feeder study who are hospitalized within 2 weeks of rollover, contact sponsor to determine eligibility.
•Have any other current Axis I psychiatric diagnoses (as defined in DSM-IV-TR) 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 patients who are rolling over from a feeder study who will have completed a clinical trial of Pomaglumetad Methionil.
•Patients 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 Visit 1, or who have received any clozapine at all during the month before Visit 1.
•Patients who have a history of an inadequate clinical response, in the opinion of the investigator, to antipsychotic treatment for schizophrenia.
•Patients who require concomitant treatment with any other medication with primary central nervous system (CNS) activity, other than those allowed.
•Patients who have received treatment with any depot formulation of an antipsychotic medication within 1 dosing interval, minimum of 4 weeks, prior to Visit 1.
•In the clinician's judgment, patients who, for any reason, are considered to be a danger to themselves, or who have answered yes” to either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the Suicidal Ideation portion of the C-SSRS, or answer yes to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the Suicidal Behavior portion of the C-SSRS; and the ideation or behavior occurred within the past month.
•DSM-IV-TR diagnosis of substance dependence or substance abuse (except nicotine and caffeine) within the 6 months prior to Visit 1.
•Diagnosis of substance-induced psychosis by DSM-IV-TR criteria within 7 days of Visit 1 (or at any time during the study).
•Female patients who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study.
•Have known, uncorrected, narrow-angle glaucoma.
•Have a history of one or more seizures.
•Patients who have had electroconvulsive therapy (ECT) within 3 months of Visit 1 or who will have ECT at any time during the study.
•Patients with untreated hyper- or hypothyroidism.
•Have leukopenia (white blood cells [WBC] <3500/mm3, or <3.5 GI/L, or <3.5 103/uL) or a history of leukopenia without a clear and resolved etiology, or known history of agranulocytosis (absolute neutrophil count <500/mm3, or <0.5 GI/L, or <0.5 103/uL) during the patient’s lifetime.
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Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified