Efficacy and safety of intranasal administration of haloperidol in agitated schizophrenic patients: a controlled, blinded, randomized and single-center clinical trial

Fundació Parc Taulí0 sites40 target enrollmentJune 9, 2014

Overview

No summary available.

Registry

who.int

Start Date

June 9, 2014

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Fundació Parc Taulí

•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

•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