Randomised Trial Ketiapine Olanzapine Fast Sedation Agitated Patients Emergency Ward

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03216941
• Date of registration: 10/07/2017
• Prospective Registration: No
• Primary sponsor: Universidad Nacional de Rosario
• Public title: Randomised Trial Ketiapine Olanzapine Fast Sedation Agitated Patients Emergency Ward IM-OK-FAST
• Scientific title: Prospective Randomised Double Blind Trial of Ketiapine and Olanzapine Comparative Efficacy for Fast Sedation of Severely Agitated Patients in Emergency Psychiatric Ward
• Date of first enrolment: January 1, 2015
• Target sample size: 500
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03216941
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Care Provider).
• Phase: Phase 4

Countries of recruitment

Argentina

Key inclusion & exclusion criteria

Inclusion Criteria:

- signs of agitation,

- age between 18 and 64 years,

- bipolar (maniac or mixed episode)

- psychotic disorder diagnosis

- disorders due to drug abuse,

- organic disorder,

- anxiety or personality disorder

- Overt Agitation Severity Scale Total Score (OASS) equal or greater than 20

- Overt Aggressive Scale (OAS) with four or more positive items.

Exclusion Criteria:

- failure to agree to participate in the study,

- incapability of completing all steps

- unstable clinical disease -

- pregnancy



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Psychiatric Disorder

Emergency Psychiatric

Tranquilizers

Psychomotor Agitation

Intervention(s)

Drug: Ketamine

Primary Outcome(s)

sedation status [Time Frame: 1 to 12 hours]

Secondary Outcome(s)

adverse effects [Time Frame: 1 to 24 hours]

Secondary ID(s)

msm1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors