to compare the efficacy in the prevention of relapse to manic, depressive, or mixed episodes in two groups of bipolar I patients MedDRA version: 14.1 Level: PT Classification code 10004939 Term: Bipolar I disorder System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Zyprexa
Product Name: Olanzapina
Product Code: LY170053
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: OLANZAPINA
CAS Number: 132539-06-1
Current Sponsor code: Zyprexa
Other descr
Sponsors
Lilly.S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Male or female outpatients aged 18 years or older. [2] Women enrolled in this trial who are of childbearing age must be using contraceptive methods that are appropriate in the opinion of the investigator. [3] All patients must have the intellectual capacity necessary to understand and complete all the evaluations called for in the protocol. [4] Each patient (or the person acknowledged as his/ her legal representative) must understand the nature of the study and sign an informed consent form before any study procedure is undertaken. [5] Subjects must have a diagnosis of Bipolar I Disorder and must have recently experienced a manic or mixed episode according to DSM IV TR diagnostic criteria, whether or not said episode required hospital admission. [6] Participants must be in syndromic remission, according to DSM IV TR criteria, as well as symptomatic [remission] of the manic or mixed episode at the time of enrolment in the study, with a total YMRS score of ? 12 and a HAMD score of ? 8 at Visit 1 and Visit 2. [7] Olanzapine in mono or co-therapy must have been prescribed in all patients in order to achieve remission and treatment [with olanzapine] must have been maintained until the time of inclusion in the study. [8] Patients must have suffered at least 2 manic or mixed episodes, including the current episode, in the course of the 3 years prior to inclusion in the study 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 108 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 107
Exclusion criteria
Exclusion criteria: [9] Patients who have not experienced symptomatology of manic or mixed episodes in the month prior to admission into the study. [10] Patients who at the time of inclusion or at other time during the study require treatment with antiepileptics or other substances with a potential mood-stabilizing effect (p. eg. New antiepileptics) other than lithium, valproic acid and/ or carbamacepine. (See section 5.7.) [11] Personnel at the center of investigation who are directly related with the study or their immediate family. The term ?immediate family members? refers to spouse, parents, children, and siblings, both natural and adopted. [12] Lilly personnel (that is, personnel with a permanent or temporary contract [with Lilly], or people designated and in charge of conducting this study). Members of the immediate families of Lilly personnel may participate in clinical trials sponsored by the company, but they may not do so at Lilly facilities. The term ?immediate family members? refers to spouse, parents, children, and siblings, both natural and adopted. [13] Serious, unstable illness (including cardiac, hepatic, renal, respiratory, endocrine, neurological, hematological illnesses, morbid obesity and malnutrition) or anticipated hospitalization during the following six months, in the opinion of the clinical investigator. [14] Treatment during the last 30 days with a medication that has not been approved by healthcare authorities at the time of enrolment into the study (Visit 1) or with a drug under study in another clinical trial. [15] Clinical history of intolerance, allergic reaction, or serious adverse events with olanzapine. [16] Pregnant female patients or nursing mothers. [17] Confirmed diagnosis of schizophrenia or other psychotic disorder (schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to medical illness or substances use, psychotic disorder not otherwise specified) according to DSM IV TR criteria. [18] If the investigator believes there to be a risk of suicide. [19] Patients who achieve remission with ETC (electroconvulsive therapy) as adjunct to psychopharmacological treatment. [20] Substance use or abuse if it constitutes the primary diagnosis and the mood disorder is due to said use or abuse. [21] Refractory hypo- or hyperthyroidism. Patients receiving replacement therapy must be asymptomatic on stable doses for at least two weeks before Visit 1. 6.A.3. Criterion for Admission into Study Period III [22] Participants must be in syndromic and symptomatic remission of the manic, depressive, or mixed episode according to DSM IV TR criteria at the time of randomization, Visit 6, with a total score on the YMRS Scale of ? 12 and a score on the HAMD 21 of ? 8, scores that must have been maintained during Period II, allowing said scores to have been higher on a single occasion (under no circumstances at Visit 6) and that have not met criteria for symptomatic relapse (YMRS ? 15 and/ or HAMD ? 15). 6.A.4. Criterion for Admission into Study Period IV [23] The patients that are enrolled in the study are those that suffer syndromic and/ or symptomatic relapse (YMRS ? 15 and/ or HAMD ? 15) from the treatment arm that discontinued treatment with olanzapine. 6.A.5. Exclusion Criterion for Study Period IV [24] Patients requiring hospitalization following the discontinuation of treatment with olanzapine as of Study Period III.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to compare the efficacy in the prevention of relapse to manic, depressive, or mixed episodes in two groups of bipolar I patients who responded to open-label treatment with olanzapine in mono or co-therapy and who are in symptomatic and syndromic remission at the time of entering the study. The first group will receive olanzapine for a period of 3 months following inclusion into the study; the second group will receive olanzapine for 12 months. Relapses will be evaluated in terms of the total YMRS (Young Mania Rating Scale) and HAMD-21 (the 21-item Hamilton Depression Rating Scale) scores.;Secondary Objective: ·To compare the efficacy of maintaining olanzapine for 3 months versus maintaining it for 12 months in the improvement of symptomatology in patients who had achieved remission. To compare the efficacy of long-term treatments by means of longitudinal assessment using the general subscale of the CGI BP M To evaluate the safety of maintenance treatment with olanzapine and other coadjuvant medication in both groups of follow up. To determine the impact on resource utilization the two treatment groups have To assess the differences between groups with respect to improvement in functioning and quality of life. To understand the degree of impact the illness provokes in relatives or caregivers throughout the study. The self-report scale of family burden (Escala de Carga Familiar ? ECF) will be used for this purpose;Primary end point(s): The main efficacy measures to be used in this study are the YMRS and HAMD 21 scales. Special attention will be given to the inclusion of the criterion of hospital admission within the framework of psychopathological relapse. The Young Mania Scale is used to assess severity of manic symptoms and consists of 11 items. Items 5, 6, 8, and 9 are rated on a scale of 0 to 8, with 8 being the score that indicates the greatest symptom severity possible. The remaining items are rated | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 2 years;Secondary end point(s): The Total BPRS is a routinely used scale. Its use is aimed at evaluating psychopathology. It contains 18 items that are given a score of 1 to 7 according to severity. However, in the analysis, the scale will be rated from 0 to 6. The total score will vary between 0 and 108. The BPRS positive subscale is made up of items 2, 3, 6, and 23 from the global scale and it has a range of 0 to 24. It is useful for measuring positive psychotic symptoms. The CGI BP S Scale measures the severity of the mental disorder adjusted for bipolar disorder. It assesses manic and depressive symptoms, as well as the disorder in general at the time of evaluation. Scores fall within a range of 1 to 7, with 7 being the score that indicates the greatest degree of severity. The CGI BP M scale enables a longitudinal assessment of the disease to be performed. It is especially useful for evaluating the efficacy of long-term treatments. It is comprised of three subscales: mania, depression, and general. The first two refer to the patient?s acute situation and examine how the patient has been since his/ her last evaluation. The general subscale refers to the longitudinal status of the patient since starting the study medication. The first time this subscale is administered, prior to admission into the study, the time period under consideration will be the year before evolution if the time of introduction of the new treatment is unknown. This scale differs from the CGI BP S in that the correlation between the three subscales may not necessarily be congruent, so that a patient who has a low score on the mania and/ or depression subscale may have a high global score if he/ she presents a rapid cycling course of the illness during the previous year. | — |
Countries
Spain
Contacts
Public ContactClinical Operations
Lilly .S.A
Outcome results
None listed