PER-038-99已完成未知
OLANZAPINE VERSUS HALOPERIDOL IN THE TREATMENT OF ACUTE MANIA
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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.
研究者
相似试验
尚未招募
3 期
A comparative study of Olanzapine and Haloperidol in treating Delirium in ICU settingsCTRI/2023/03/051110Pacific Medical College and Hospital
已完成
不适用
OLANZAPINE VERSUS ZIPRASIDONE IN THE TREATMENT OF SCHIZOPHRENIA-F20F20PER-066-01ELI LILLY INTERAMERICA INC.,
招募中
2 期
Comparison the effect of Olanzapine and Haloperidol on the treatment of delirium in ICU in Valiasr hospitalIRCT20141209020258N114Arak University of Medical Sciences50
招募中
3 期
Comparison of olanzapine and haloperidol and quetiapine on deliriumDelirium.Delirium due to known physiological conditionIRCT20200927048852N1Arak University of Medical Sciences90
已完成
3 期
Effect of olanzapine in delirium of poisoning patientIRCT20190928044909N1Shahid Beheshti University of Medical Sciences36