Bipolar I Disorder (Manic or Mixed Episodes) or Schizophrenia MedDRA version: 13.1 Level: HLGT Classification code 10039628 Term: Schizophrenia and other psychotic disorders System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 13.1 Level: PT Classification code 10057667 Term: Bipolar disorder System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Zyprexa 2,5 mg
Pharmaceutical Form: Coated tablet
INN or Proposed INN: OLANZAPINE
CAS Number: 132539061
Current Sponsor code: F1D-MC-HGMX
Other descriptive name: HGMX
Concentration unit: m
Sponsors
Eli Lilly
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible for inclusion in this study only if they meet all of the following criteria: [1] Have a diagnosis of bipolar I disorder and display an acute manic or mixed episode (with or without psychotic features) according to the DSM-IV-TR and confirmed by the K-SADS-PL, including the following diagnoses: 296.4x Bipolar I Disorder, Most Recent Episode Manic and 296.6x Bipolar I Disorder, Most Recent Episode Mixed. OR: Have a diagnosis of schizophrenia (295.10, 295.20, 295.30, 295.60, and 295.90) according to the DSM-IV-TR and confirmed by the K-SADS-PL Patients must meet diagnostic criteria at Visits 1 and 2. [2] Meet severity criteria as follows: Patients with a diagnosis of schizophrenia must obtain a BPRS-C total score >30, with a minimum score of 3 on at least one of the following items at both Visits 1 and 2: • hallucinations • delusions • peculiar fantasies. Patients with a diagnosis of bipolar I disorder must have a YMRS total score =15 at both Visits 1 and 2. [3] All females must test negative for pregnancy and must agree to abstain and/or be using a medically accepted means of contraception during the study. [4] Has given assent (when applicable); and has a parent or authorized legal representative who has given informed consent, is reliable, has a level of understanding sufficient to permit patient to perform all tests and examinations required by the protocol, and understands the nature of the study. [5] Are male or female patients, 13 to 17 years of age, who will not reach their 18th birthday before Visit 1, when informed consent is obtained. [6] Are capable of swallowing study medication whole (without crushing, dissolving, etc.). Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: [7] Have a history of mental retardation, current comorbid autism, or current comorbid Pervasive Developmental Disorder. [8] Have DSM-IV-TR substance (except nicotine and caffeine) dependence within the past 30 days prior to Visit 2. [9] Have been judged clinically to be at any suicidal risk. [10] Have undergone treatment with remoxipride within 6 months (180 days) prior to Visit 2. [11] Have a history of allergic reaction or hypersensitivity to olanzapine. [12] Are receiving current pharmaceutical treatment for weight management or are participating in a structured behavioral diet and/or exercise weight loss program. [13] Other antipsychotics, mood stabilizers, or anticonvulsants used for the primary study conditions are excluded. Patients on these medications must have them discontinued 2 days prior to Visit 2. [14] Have acute, serious, or unstable medical conditions, including (but not limited to): • inadequately controlled diabetes (hemoglobin A1c [HgbA1c] >8%) • severe hypertriglyceridemia (fasting triglycerides =500 mg/dL [=5.65 mmol/L]) inadequately controlled thyroid disease (Patients needing a thyroid hormone supplement to treat hypothyroidism must have been on a stable dose of the medication for at least 2 months (60 days) prior to Visit 2.) • known uncorrected narrow-angle glaucoma • hepatic insufficiency (specifically any degree of jaundice) • cerebrovascular accidents • serious acute systemic infection or immunologic disease (including Human Immunodeficiency Virus positive status) • unstable cardiovascular disorders (including ischemic heart disease) • any other major renal, gastroenterologic, respiratory, endocrinologic, neurologic, or hematologic diseases (including current absolute neutrophil count 200 ng/mL (>200 ug/L, or >4228 mIU/L) at Visit 1. [20] Have QTc (Bazett’s) >450 milliseconds (males) or >460 milliseconds (females) at Visit 1. [21] Have previously been randomized in this study and/or participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to study entry (Visit 1). [22] Patient is currently prescribed olanzapine and has been taking olanzapine =5 days within 1 month (30 days) prior to Visit 1. [23] Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess, in adolescent patients with bipolar I disorder (mania or mixed episode) or in adolescents with schizophrenia: • overall safety of olanzapine for up to approximately 52 weeks of treatment (as described in Section 10.1), and • whether an intense behavioral weight intervention program is superior to a standard behavioral weight intervention program in mitigation of weight gain. The behavioral interventions will be assessed based on mean change from baseline body mass index (BMI) for patients with duration of treatment of at least 6 months.;Secondary Objective: • to assess the mean change from baseline in BMI for all patients. • to assess the time to event for 7%, 15%, and 25% weight gain between patients randomized to an intense behavioural weight intervention or standard behavioral weight intervention program. • to assess the mean change from baseline in waist circumference for all patients. • to assess the efficacy of oral olanzapine treatment in adolescents, as measured using psychiatric assessments including rating scales that will assess symptoms of bipolar I disorder (Adolescent Structured Young Mania Rating Scale [YMRS]) or schizophrenia (Anchored Version of the Brief Psychiatric Rating Scale for Children [BPRS-C]) and clinical global evaluations (Clinical Global Impression of Improvement/Severity [CGI-I/CGI-S]). ;Primary end point(s): Safety evaluations are primary measures in this long-term safety study of olanzapine treatment in adolescent patients. There is no primary efficacy measure in this study as safety is the primary objective. | — |
Countries
Germany
Outcome results
None listed