A Phase 3, Multicenter, Double-Blind Comparison of LY2140023 and Aripiprazole in Patients with Schizophrenia Followed by Open-Label Treatment with LY2140023
- Conditions
- SchizophreniaMedDRA version: 14.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2010-023550-36-ES
- Lead Sponsor
- illy S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 670
[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. Menopausal women include women in either of the following categories:
[a] Spontaneous amenorrhea for at least 12 months, not induced by a
medical condition such as anorexia nervosa and not taking medications
during the amenorrhea that induced the amenorrhea (for example, oral
contraceptives, hormones, gonadotropin releasing hormone, antiestrogens, selective estrogen receptor modulators (SERMs), or
chemotherapy). or [b] Spontaneous amenorrhea for 6 to 12 months and a follicle-stimulating hormone (FSH) level greater than 40mIU/mL.
[3] In the opinion of the investigator, at Visit 1, patients must require initiation of or modification to current antipsychotic treatment as outpatients.
[4] 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.
[5] 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 670
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
[6] Are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an investigational product or nonapproved use of a drug or device, or concurrently enrolled in any other type of medical research
[7] Are investigator site personnel directly affiliated with this study and/or their immediate families
[8] Lilly employees.
[9] on treatment with aripiprazole in the past 2 months or aripiprazole nonresponders.
[10] Patients for whom treatment with LY2140023 or aripiprazole is relatively or absolutely clinically contraindicated.
[11] Are hospitalized within 2 weeks of Visit 1 or have been hospitalized for anexacerbation of symptoms of schizophrenia with a discharge date in the past 2months
[12] Have any other current Axis I psychiatric diagnoses
[13] Have previously completed or withdrawn from this study, or any other study investigating LY2140023 or any predecessor molecules with glutamatergic activity
[14] Patients who have received an adequate treatment trial 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
[15] Patients who have a history of an inadequate clinical response to antipsychotic treatment for schizophrenia
[16] Patients who require concomitant treatment with any other medication with primary central nervous system activity
[17] 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.
[18] 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.
[19] diagnosis of substance dependence or abuse
[20] Diagnosis of substance-induced psychosis within 7 days of Visit 1 (or at any time during the study).
[21] Female patients who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study.
[22] Have known, uncorrected, narrow-angle glaucoma.
[23] Have a history of one or more seizures except for: A single simple febrile seizure between ages 6 months and 5 years or A single seizure with an identifiable etiology, which has been completely resolved.
[24] Patients who have had ECT within 3 months of Visit 1 or who will have ECT at any time during the study.
[25] Patients with untreated hyper- or hypothyroidism
[26] Have leukopenia or a history of leukopenia without a clear and resolved etiology, or known history of agranulocytosis during the patient?s lifetime.
[27] Patients with known medical history of Human Immunodeficiency Virus positive (HIV+) status.
[28] Test positive for (1) Hepatitis C virus antibody or (2) Hepatitis B surface antigen (HBsAg) with or without positive Hepatitis B core total antibody. Patients with positive Hepatitis B core antibody test and negative HBsAg may be included in the study if ALT/SGPT and AST/SGOT levels are less than 2 times the upper limit of normal (ULN) and total bilirubin does not exceed the ULN of the central laboratory
[29] Patients with ALT/SGPT or AST/SGOT values >2 times ULN of the p
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method