Acute pre/agitated patients with personality disorder
Conditions
Interventions
Trade Name: ADASUVE 9.1 mg inhalation powder, pre-dispensed
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: Loxapine
CAS Number: 1977-10-2
Other descriptive name: LOXAPINE
C
Sponsors
Vall d'Hebron University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient able to read and understand the patient's information sheet Patient who had signed voluntarily the informed consent form Men or women between = 18 and = 65 years old Pacient with a personality disorder diagnosis (as DSM-5) Pacient considered to be clinically pre-agitated or agitated with a CGI-S score above or equal to 4. 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 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any specific contraindication stated in the Summary of product characteristics. Patients with any allergy or intolerance to loxapine or amoxapine Patients with agitation caused basically by an acute intoxication (according to the investigator) Patients who are thought to have a relevant suicide risk (according to the investigator) Patients with alcohol or psycho-active drugs withdrawal symptoms or intoxication, incompatible with their clinical trial participation (according to the investigator) Patients with acute respiratory symptoms or active airway illness (such as asthma or COPD). Women with childbearing potential with a positive urine test result or women who are breastfeeding Patients with any severe acute illness or instable medical condition (other than personality disorder) that might prevent their participation in the study (according to the investigator) Any team staff or their family members, or any subordinate (or relatives) of the team staff Patients who had been given the IMP 30 days prior to the selection visit Patients who (according to the investigator) cannot follow the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the clinical trial is to assess the effectiveness, defined as time respone of loxapine 9.1mg in acute pre/agitated patients with personality disorder. This respones is define as 1 (very much improvement) or 2 (much improvement) score in the Clinical Global Impression – Improvement scale (CGI-I);Secondary Objective: To assess the effectiveness defined as PANSS-EC total score =14 and sub-item scale <4 To assess the effectiveness, defined as 4 (normal), 5 (mild calmness) or 6 (moderate calmness) score in the Agitation-Calmness (ACES) To assess the effectiveness, defined as % pacients who respond to treatment 10, 20 and 60 minutes after loxapine 9.1mg inhalation To assess the number of patients who need rescue treatment. To assess the safety and tolerability of the IMP To assess the use of mechanic restrain in the subjects of the study;Primary end point(s): Clinical Global Impression-Severity (CGI-S) Clinical Global Impression-Improvement (CGI-I);Timepoint(s) of evaluation of this end point: 0 ,10, 20 and 60 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Excited Component of the Positive and Negative Syndrome Scale (PANSS-EC) Agitation-Calmness Evaluation Scale (ACES);Timepoint(s) of evaluation of this end point: 0 ,10, 20 and 60 minutes | — |
Countries
Spain
Contacts
Public ContactPsychiatry service
Vall d'Hebron University Hospital
Outcome results
None listed