Manic or Mixed Episodes Associated with Bipolar I Disorder
Conditions
Interventions
Trade Name: ZYPREXA COATED TABLETS (5MG)
Product Name: ZYPREXA
Product Code: LY170053
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Olanzapine
Concentration unit: mg milligram(s)
Concentrati
Sponsors
ELI LILLY and COMPANY
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible to be included in the study only if they meet all of the following criteria: [1] have a diagnosis of bipolar I disorder (296.4x or 296.6x) and currently meet DSM-IV-TR criteria for a manic or mixed episode (with or without psychotic features), based on clinical assessment and confirmed by the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Axis I Disorders (SCID-I: Clinical Version). [2] are a male or female, inpatient or outpatient, between the ages of 18 and 65 years. [3] all female patients of childbearing potential must test negative on a serum pregnancy test at the time of enrollment and agree to use a medically accepted means of contraception throughout the study. NOTE: hormonal methods of birth control (the pill, injections, or implants) may be less effective due to a possible interaction with carbamazepine. All patients using these types of birth control should be considered for alternative forms of birth control. [4] are reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, understand the nature of the study, and have given informed consent. [5] have YMRS total score ³20 at both Visits 1 and 2. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: General: [6] are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. [7] are employed by Lilly (that is, employees, temporary contract workers, or designees responsible for conducting the study). Immediate family of Lilly employees may participate in Lilly?sponsored clinical trials, but are not permitted to participate at a Lilly facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. [8] have received treatment within the last 30 days prior to study entry (Visit 1) with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry. [9] have participated (been randomized) in a clinical trial of another investigational drug (including olanzapine or carbamazepine) within 30 days prior to Visit 1. [10] are actively suicidal (for example, any suicide attempts within the past month or any current suicidal intent including plan) in the clinical judgement of the investigator. [11] are female patients who are either pregnant or nursing. [12] have known, uncorrected, narrow-angle glaucoma. Safety-related: [13] have a clear, documented history of allergic or adverse reaction to olanzapine or carbamazepine, or had treatment withdrawn due to clinically significant and/or intolerable adverse effects, treatment resistance to, or lack of response to an adequate trial of olanzapine or carbamazepine, as determined by the investigator. [14] have experienced one or more seizures without a clear and resolved etiology. However, if the patient has had one or more seizures in the past with an identifiable etiology, and that etiology has been resolved, the patient may be entered. Note: the site must contact the sponsor or its representatives prior to entering a patient who has experienced any seizure. [15] have a history of agranulocytosis (absolute neutrophil count 8%); severe hypertriglyceridemia (fasting triglycerides ³500 mg/dL); hepatic insufficiency (specifically any degree of jaundice); recent cerebrovascular accidents; uncontrolled seizure disorders; serious, acute systemic infection or immunologic disease; unstable cardiovascular disorders (including ischemic heart disease); or renal, gastroenterologic, respiratory, endocrinologic, neurologic, or hematologic diseases (specifically current absolute neutrophil count 200 ng/mL at Visit 1, with the exception of patients presently treated with risperidone. Patients treated with risperidone are excluded if the prolactin level is >300 ng/mL at Visit 1. [20] have a history of severe thrombocytopenia (platelet count of <50,000/µL) during the patient’s lifetime or current thrombocytopenia (platelet count of <100,00
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the superiority of olanzapine (up to 30 mg/day) plus carbamazepine (400 to 1200 mg/day) versus placebo plus carbamazepine (400 to 1200 mg/day) in improving overall manic symptomatology in patients with mania associated with bipolar I disorder. ;Secondary Objective: The main secondary objectives of this study are to compare the efficacy and safety of up to 6 weeks of double-blind, concomitant use of olanzapine (up to 30 mg/day) plus carbamazepine to the concomitant use of placebo plus carbamazepine, using the following assessments: · rate of response and time to response, · rate of remission and time to remission of mania, · reductions from baseline to the endpoint on the MADRS, CGI and YMRS total score, · change in vital signs, laboratory values, ECGs, treatment-emergent adverse events and extrapyramidal symptoms.;Primary end point(s): The improvement in manic symptoms will be measured by a reduction in the total score of the Young Mania Rating Scale (YMRS [Young et al. 1978]) from baseline to endpoint during the 6-week, double-blind treatment phase. | — |
Countries
Hungary
Outcome results
None listed