None listed
Conditions
Interventions
Patients enter period 2 (acute double-blind period) where they receive olanzapine 5-20 mg / day orally for 6 weeks.
Then they enter Period 3 (double blind continuation period) where they will continue with the medication in the same way for 6 weeks.
During period 4, all groups will receive olanzapine 5-20 mg / day orally for 6 months
Group name:Haloperidol Type of group
Patients enter period 2 (acute double-blind period) where they receive Haloperidol 3-15 mg / day orally for 6 weeks.
Then they enter Period 3 (double blind continuation period) where they will continue with the medication in the same way for 6 weeks.
During period 4, all groups will receive olanzapine 5-20 mg / day orally for 6 months
Sponsors
ELI LILLY INTERAMERICA INC.,
Eligibility
Inclusion criteria
Inclusion criteria: • Men or women, minimum age 18 years, hospitalized or ambulatory patients. • Women of childbearing age should be using a contraceptive method of medical acceptance. • Each of the patients must have a level of understanding that can express their agreement to perform all tests and examinations required in the protocol. • Patients should be considered reliable. • Each patient (and / or an authorized legal representative of the patient) must understand the nature of the study and sign an informed consent document. • Patients must have a diagnosis of bipolar I disorder and present an acute manic or mixed episode (with or without psychotic features) according to the DSM-IV (Annex HGHD.´2.) Based on the clinical evaluation and confirmed by structured diagnostic interview SCID-P. This includes the following diagnoses: 296.Ox, Bipolar I Disorder, Single Manic Episode; 296.4x, Bipolar disorder I, most recent manic episode; 296.6x, Bipolar Disorder I, most recent mixed episode. • Patients must have a total Y-MRS score of> 20 in both Visit 1 and Visit 2.
Exclusion criteria
Exclusion criteria: • Researchers and immediate family members, defined as the researcher´s spouse, father or mother, children, grandparents or grandchildren. • Participation in a clinical study of another investigational medication within a month (30 days) prior to entering the study (Visit 1). • Women who are pregnant or breast-feeding. • Serious unstable medical condition, including liver, kidney, gastroenterological, respiratory (cardiovascular (including ischemic heart disease), endocrinological, neurological, immunological or hematological disease of such magnitude that death is anticipated within 1 year or hospitalization in unit of intensive therapy for the disease in the course of 6 months. • Hypothyroidism or uncorrected hyperthyroidism. • Narrow angle glaucoma. • One or more seizures without clear and resolved etiology. Note: The site should contact the sponsor before admitting a patient who has experienced any type of seizure. • Current agranulocytosis (absolute neutrophil count <500 mm3). • Current jaundice, hepatitis B positive surface antigen (HBsAg) or positive IgM fraction of the hepatitis B core antibody (anti-HBc [IgM]). Note: Hepatitis B positive total core antibody (anti-HBc) and hepatitis C positive total viral antibody (anti-HCVab) are not exclusion criteria. • Documented history of intolerance to olanzapine or haloperidol, or lack of response in an adequate study of said drugs, at the investigator´s discretion. • Substance abuse according to DSM-IV (with the exception of nicotine and caffeine) within the last 30 days. • Treatment with an injectable depot neuroleptic within less than one administration interval between injections of neuroleptic drugs before Visit 2. • Treatment with a reversible monoamine oxidase inhibitor, guanethidine or guanadrel within the week prior to Visit 2. • Treatment with a non-reversible monoamine oxidase inhibitor within 2 weeks prior to Visit 2. • Treatment with remoxipride within 6 months (180 days) prior to Visit 2. • Treatment with psychotropic medication, including lithium and valproate (except benzodiazepines and anticholinergics) the day before Visit 2. Refer to the guidelines on discontinuation of medications in Section 3.8. • Any other concomitant medication with activity primarily on the central nervous system that is not specified in Section 3.8, the day before Visit 2. Consult the guidelines on discontinuation of psychotropic medications in Section 3.8. • Treatment with clozapine within 4 weeks prior to Visit 2. • Current diagnosis of schizophrenia or other psychotic disorders (including schizophreniform disorder, schizoaffective disorder, primary delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, psychotic disorder induced by substances, psychotic disorder not specified) DSM-IV criteria. • Current diagnosis of major depressive disorder, dysthymic disorder, unspecified depressive disorder, bipolar I disorder (most recent episode depressed), bipolar I disorder (most recent hypomanic episode), bipolar I disorder (most recent episode not specified), or bipolar disorder ü, according to DSM-IV criteria. • That a serious suicide risk is judged from the clinical point of view. • Treatment with sustained release carbamazepine within the week prior to Visit 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Proportion of patients who complete 6 weeks of acute double-blind treatment and meet the criteria for symptomatic remission in week 6 Various scales will be used: -Y-MRS -PANSS -scale for psychiatric depression for Hamilton -scale for psychiatric depression of Montgomery-Asberg -CGI-BP, to measure severity Measure:Improvement of global manic symptomatology Timepoints:6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical history, psychiatric and physical exams, including electrocardiography. Measure:Safety Timepoints:During Treatment and follow up ; Outcome name:The overall rating of Young Mania Rating Scale, PANSS - Positive and Negative Syndrome Scale, HAMD-21 - Hamilton Psychiatric Rating Scale for Depression, MADRS - Montgomery-Asberg Depression Rating Scale will be used Measure:Improve clinical symptomatology in patients diagnosed with bipolar disorder I who are currently exhibiting manic or mixed symptoms Timepoints:6 weeks ; Outcome name:Proportion of patients who have completed 6 weeks of acute double-blind treatment and fulfilled the criteria of symptomatic remission, and who subsequently fail to maintain clinical improvement in the double-blind maintenance stage. Measure:Maintain improvement in clinical symptoms Timepoints:6 weeks ; Outcome name:The reductions in total YMRS rating will be used; total, positive and negative ratings of the PANSS; total rating of HAMD-21; MADRS total rating; and CGI-BP Severity Measure:Improve clinical symptoms in patients diagnosed with a manic or mixed episode associated with bipolar I disorder, after a total of 12 weeks of double-blind treatment Timepoints:12 weeks ; Outcome name:Proportion of patients who complete 12 weeks of acute double-blind treatment and maintenance and who meet the criteria for symptomatic remission in week 12. Measure:Improve global manic symptomatology Timepoints:12 weeks ; Outcome name:The patients attitude will be evaluated using the Drug Attitude Inventory Measure:Patient satisfaction and attitude Timepoints:During all of the study | — |
Countries
Peru
Outcome results
None listed