None listed
Conditions
Interventions
Drug : LY2140023 [20, 40, or 80 mg], given orally twice daily. Olanzapine, aripiprazole, risperidone, or quetiapine, given orally and up to 52 weeks, consistent with approved labeling and local practi
Sponsors
Eli Lilly Korea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Male or female patients, 18 to 65 years of age (inclusive) at the time of entry to the feeder study. [2] Must have met all entry criteria for, and have completed, an acute, placebo-controlled clinical trial of LY2140023 (such as Study H8Y-MC-HBBM, Study H8Y-MC-HBBN, Study H8Y-MC-HBBP, or other acute, placebo-controlled LY2140023 studies if allowed by the protocols for those studies). [3] Female patients of childbearing potential must 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. In addition, the double-barrier method, defined as 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 postmenopausal, would not require any other form of contraception. For female patients whose reproductive status changes during the study, contraception may be discontinued if menopause is confirmed by either of the following: [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, anti-estrogens, 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. [4] Patients must be considered reliable and have a level of understanding sufficient to perform all tests and examinations required by the protocol. [5] Patients must be able to understand the nature of the study and have given their own informed consent.
Exclusion criteria
Exclusion criteria: [1] Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. [2] Are Lilly employees or employees of third-party organizations involved in the study who require exclusion of their employees. [3] Are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an investigational product or nonapproved use of a drug or device (other than LY2140023), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. [4] Patients for whom treatment with olanzapine, risperidone, aripiprazole, quetiapine, or LY2140023, as specified in this protocol, is relatively or absolutely clinically contraindicated. [5] 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. [6] 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 3). [7] 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. [8] Patients diagnosed (per DSM-IV-TR) with substance dependence or substance abuse (except nicotine and caffeine) within the 6 months prior to Visit 1. [9] Patients diagnosed (per DSM-IV-TR) with substance-induced psychosis within 7 days of Visit 1 (or at any time during the study). [10] Female patients who are pregnant, nursing, lactating or who intend to become pregnant within 30 days of completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to discontinuation due to lack of tolerability | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment Emergent Adverse Events (TEAEs) | — |
Countries
Korea, Republic of
Contacts
Public ContactJungsik Lee
Yongin Mental Hospital
Outcome results
None listed