Agitation in schizophrenic patients MedDRA version: 17.0 Level: PT Classification code 10001497 Term: Agitation System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Pharmaceutical Form: Nebulisation solution
INN or Proposed INN: Haloperidol
CAS Number: 52-86-8
Other descriptive name: HALOPERIDOL
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
Fundació Parc Taulí
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and women between 18 and 65. Patients with a diagnosis of schizophrenia according to DSM V diagnostic criteria. Patients presenting with psychomotor agitation (more than or equal to 14 score (where the max value is 35) in the overall scale score or 4 (where the max value is 7) in at least 1 of the 5 items comprising the scale). Patients in whom the treatment with an antipsychotic by intramuscular route is indicated. Patients who consented to participate in the study / patients whose representative granted his/her participation 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 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnant or breast-feeding women. Patients with exacerbated medical comorbidity (respiratory, hepatic, renal, gastrointestinal, cardiovascular, endocrine, neurological or haematological). Patients with delirium. Patients with severe risk of suicide. Patients with hypersensitivity to haloperidol or any of the excipients or any situation in which the administration of haloperidol is contraindicated according to the summary of product characteristics: comatose state, CNS depression caused by alcohol or other depressant drugs, Parkinson's disease, basal ganglia damage). Patients with abuse / drug dependence (alcohol and / or sympathomimetic) within the two months prior to the study. Patients with cocaine or other sympathomimetic intoxication. Patients who have received benzodiazepines or other short-acting hypnotics or antipsychotics by oral ir intramuscular route within the 4 hours prior to the start of clinical trial. Patients who have been administered with a depot antipsychotic previous to the study. Patients for which consent to participate has not been obtained Patients who in the opinion of the responsible physician the participation in the study can be a clinical harm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare intranasal administration of 5 mg haloperidol in agitated patients with schizophrenia treated in the emergency room with intramuscular administration in terms of time required for patient sedation;Secondary Objective: Compare the degree of sedation obtained with intranasal administration of 5 mg of haloperidol in agitated patients with schizophrenia compared with intramuscular administration. Compare the time to administration of a rescue dose between the control and experimental groups. To evaluate the safety and tolerability obtained with both administration routes. Describe the number and severity of accidents related to the management of the patient in psychiatric emergencies during the period of turmoil;Primary end point(s): Proportion of patients with controlled agitation (defined as an average score of 9 in the PANSS scale-EC (5 items)) at 20 minutes after administration of treatment);Timepoint(s) of evaluation of this end point: 20 minutes after administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of responders, defined by a score of 1 or 2 of the CGI-S scale after 45 minutes of administration of the medication. Changes from baseline in the PANSS-EC scale from 20 minutes in the different evaluations performed up to 6 hours. Elapsed time to administration of the second dose. Number and type of reported adverse effects: Adverse effects will be controlled through the continuous monitoring of patients, physical and laboratory examination. If necessary a specific medical - psychiatric intervention will be done by the responsible investigator. If the patient has extrapyramidal symptoms including acute dystonia, anticholinergic biperiden 4mg will be administered intramuscularly. Excessive sedation, as assessed via BARS scale after two hours of dosing. Number and severity of related incidents related to the agitation and the administration of treatment to control it. Rating of the difficulty in administration of treatment measured by means of a VAS scale;Timepoint(s) of evaluation of this end point: different timeponits during 6 hours after administration | — |
Countries
Spain
Contacts
Public ContactOficina de Recerca
Fundació Parc Taulí
Outcome results
None listed