A Phase 2, Multicenter, Double-Blind, Placebo-Controlled Comparator Study of 2 Doses of LY2140023 versus Placebo in Patients with DSM-IVTR Schizophrenia - HBBM(a)

• Conditions: Schizophrenia; MedDRA version: 12.1Level: LLTClassification code 10039626Term: Schizophrenia

• Registration Number: EUCTR2009-017852-28-DE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-22
• Last Update Posted: 28 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 880

Inclusion Criteria

[1] Patients are male or female, 18 to 65 years of age (inclusive) at study
entry, with a diagnosis of schizophrenia as defined in the Diagnostic
and Statistical Manual of Mental Disorders, Fourth Edition, Text
Revision (DSM-IV-TR; APA 2000) (Disorganized, 295.10; Catatonic,
295.20; Paranoid 295.30; or Undifferentiated, 295.90) and confirmed
by the Structured Clinical Interview for DSM-IV-TR (SCID).
[2] 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, specifically: an oral contraceptive
combined pill; an implantable contraceptive; an injectable
contraceptive; a contraceptive patch (for women <198 pounds or 90
Kg); or an intrauterine device/system. The double-barrier method, as
defined by two physical barriers such as a condom, diaphragm, or
cervical occlusive cap, coupled with an additional barrier such as
spermicidal foam, gel, film, cream or suppository, is also an acceptable
method of birth control. Patients having undergone a hysterectomy or
bilateral oophorectomy or other form of female sterilization, or
patients having been medically confirmed to be post-menopausal,
would not require any method of contraception.
[3] At Visits 1 and 2, patients must meet a Clinical Global Impression-
Severity (CGI-S) rating =4 (moderately ill) and must be patients in
whom a modification of antipsychotic medication, or the initiation of
antipsychotic medication, is acutely indicated, in the opinion of the
investigator.
[4] Patients must be willing to participate in a minimum of 3 weeks of
inpatient hospitalization, and this must be appropriate for the patient in
the clinical judgment of the investigator.
[5] Patients must have been suffering from schizophrenia for at least 1
year prior to Visit 1, as determined from onset of illness.
[6] At Visit 1, patients who are not antipsychotic treatment-naive must
have a lifetime history of at least one hospitalization for the treatment
of schizophrenia, not including hospitalization required for this study.
Patients who are antipsychotic treatment-naive may enter the study,
even without a history of hospitalization.
[7] At Visit 1, patients who are not antipsychotic treatment-naïve must
have a history of at least one episode of illness exacerbation requiring
an intensification of treatment intervention or care in the last 2 years,
not including the present episode of illness. Patients who are
antipsychotic treatment-naive may enter the study, even without a past
history of illness exacerbation and intensification of treatment in the
last 2 years.
[8] At Visit 1, patients also must have experienced an exacerbation of
their illness within the 2 weeks prior to Visit 1, leading to an
intensification of psychiatric care in the opinion of the investigator.
Examples of intensification of care include, but are not limited to:
inpatient hospitalization, day/partial hospitalization, outpatient crisis
management, or psychiatric treatment in an emergency room. If
exacerbation occurs in patients who are presently hospitalized, the
patient must not have been hospitalized longer than 60 days prior to
Visit 1.
[9] 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.
[10] Patients must be able to understand the nature of the study and have
given their own informed co

Exclusion Criteria

[13] Have any other current Axis I psychiatric diagnoses (as defined in
DSM-IV-TR) in addition to schizophrenia.
[16] Patients for whom treatment with risperidone, LY2140023, or placebo,
as specified in this protocol, is relatively or absolutely clinically
contraindicated.
[17] Patients who have received treatment 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.
[21] Patients who require concomitant treatment with any other medication
with primary central nervous system activity, other than those allowed
as specified in Section 9.8 and Attachment HBBM.3, or with any other
medication specifically excluded in Protocol Attachment HBBM.3.
[22] Patients currently receiving treatment (within 1 dosing interval,
minimum of 4 weeks, prior to Visit 1) with a depot formulation of an
antipsychotic medication.
[23] Patients 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.
[26] Female patients who are pregnant, nursing, or who intend to become
pregnant within 30 days of completing the study.
[27] Have known, uncorrected, narrow-angle glaucoma.
[28] Have a history of one or more seizures, except for those who
experienced a single simple febrile seizure between ages 6 months and
5 years (a single simple febrile seizure is defined as lacking focality
and lasting less than 15 minutes, not associated with a central nervous
system (CNS) infection or severe metabolic disturbance).
[29] Patients are excluded if they have a first-degree relative (that is,
biological father, mother, brother, sister, or child) with history of
idiopathic epilepsy.
[30] Within 1 year of study enrollment, patients have a history of CNS
infection, uncontrolled migraine, transient ischemic attack (TIA), or
head trauma with loss of consciousness or a post-concussive
syndrome.
[31] Patients are excluded if they have a lifetime history of any of the
following:
o head trauma, stroke, or CNS infection with persistent neurological
deficit (focal or diffuse);
o brain surgery;
o an EEG with paroxysmal (epileptiform) activity, for example, one
that demonstrates 3 or more focal sharp or spike waves, any sharp
and slow wave complex, or any epileptiform discharge that is
rhythmic, sustained, or generalized; or as locally defined; or
o brain structural lesion, including developmental abnormalities, as
determined by examination or previous neuroimaging studies that
are consistent with a diagnosable neurological disease or
syndrome.
[32] Patients who have had electroconvulsive therapy (ECT) within 3
months of Visit 1 or who will have ECT at any time during the study.
[33] Patients with untreated hyper- or hypothyroidism. An abnormal TSH
(outside the limits of the central laboratory reference range) will
automatically result in a Free T3 and a Free T4 by the central
laboratory. Patients with mildly abnormal thyroid test results may be
included if their hyper- or hypothyroidism is adequately treated based
on the investigator’s clinical assessment and interpret

Study & Design

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