Please select the eligibility criteria that correspond to the clinical trial below.
Title: Rapid Tranquilization of Violent or Agitated People in Psychiatric Emergency Settings- A Pragmatic Randomized Controlled Trial of Intramuscular Olanzepine Vs. Intramuscular Haloperidol + Promethazine.
Brief Summary: Three hundred consecutive adult patients presenting to the emergency services of the department of psychiatry and who are diagnosed by the treating doctor to be needing tranquillization to control agitated or aggressive behavior will be randomized to receive either Injection Olanzepine I.M. or Injection Haloperidol 10mg + Injection Promethazine 50 mg in this parallel group, block randomized, centrally-randomzed, allocation-concealed, assessor-blinded pragmatic clinical trial.

The main outcome measure that the two treatments would be compared on would be the clinical state of the patient 4 hours after intervention, but the rate of tranquillization, degree of sedation, proportions tranquil and / or asleep at 15, 30, 60 and 240 minutes, need for additional medication, use of physical restraints, doctors called back, numbers absconding and adverse effects at each of these time points would also be compared. Compliance with oral medication and adverse effects at the end of 2 weeks would also be compared.


Options:
A: Inclusion Criteria:

* Agitated schizophrenic patients
B: Inclusion Criteria:

* Person with a major mental disorder needs acute intramuscular sedation because of disturbed and dangerous behavior as decided by the attending physician.

Exclusion Criteria:

* The clinician believes that one of the two treatments represents an additional risk for the patient and/or
* Patients who lack capacity to give informed consent and who do not have a relative to obtain consent.
C: Inclusion Criteria:

* Patients must have schizophrenia, schizoaffective disorder, or schizophreniform disorder
* Patients must be agitated
* Patients must display psychotic symptoms
* Patients must be inpatients who are expected to stay in the hospital for at least 5 days
* Patients must be 18 to 55 years of age

Exclusion Criteria:

* Patients may not be hospitalized for greater than 72 hours prior to study start
* Patients may not have received more than one dose of olanzapine or aripiprazole within 72 hours prior to study start
* Patients may not be actively suicidal
* Patients may not be diagnosed with substance-induced psychosis or substance dependence
* Patients may not have acute, serious, or unstable medical conditions
D: Inclusion Criteria:

* Diagnosis of schizophrenia according to DSM-IV-TR criteria
* Has been able to achieve outpatient status for more than 3 months in the past year
* Body mass index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)
* Resides in a stable living situation
* Willing and able to be confined to an inpatient study unit for 2 weeks or longer

Exclusion Criteria:

* History of poor or inadequate clinical response to treatment with aripiprazole
* History of treatment resistance
* Known or suspected intolerance of, allergy, or hypersensitivity to aripiprazole, its ingredients, other antipsychotic agent, or INTRALIPID (including peanuts, soy, egg, or glycerol)
* Diagnosis of current substance dependence (including alcohol)
* Pregnant, lactating, or breastfeeding
* Receipt of any antipsychotic medication by IM injection within 60 days before Screening
* Current involuntary hospitalization or incarceration
* Hospitalized for more than 30 days during the 90 days before Screening

Additional inclusion/exclusion criteria may apply.

Answer: B