Psychomotor AgitationPhase 4IM-OK-FASTNCT03216941
Randomised Trial Ketiapine Olanzapine Fast Sedation Agitated Patients Emergency Ward
A Phase 4 study testing Ketamine in people with Psychomotor Agitation and Psychiatric Disorder, run by Universidad Nacional de Rosario at 1 site in Argentina.
Trial summary
comparison of intramuscular olanzapine and ketamine efficacy as first medication for fast sedation of patients with agitation and aggressive behavior. Five hundred patients with agitation caused by psychiatric disorder were randomly assigned under double-blind conditions to receive olanzapine or ketiapine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychomotor Agitation, Psychiatric Disorder, Emergency Psychiatric
- What is being tested?
- Ketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Jan 2015to 31 Jan 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signs of agitation,
- age between 18 and 64 years,
- bipolar (maniac or mixed episode)
- psychotic disorder diagnosis
- disorders due to drug abuse,
- organic disorder,
Show all 9Show fewer
- 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.
Who cannot join
- failure to agree to participate in the study,
- incapability of completing all steps
- unstable clinical disease -
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomised Double Blind Trial of Ketiapine and Olanzapine Comparative Efficacy for Fast Sedation of Severely Agitated Patients in Emergency Psychiatric Ward
comparison of intramuscular olanzapine and ketamine efficacy as first medication for fast sedation of patients with agitation and aggressive behavior. Five hundred patients with agitation caused by psychiatric disorder were randomly assigned under double-blind conditions to receive olanzapine or ketiapine. The Overt Agitation Severity Scale, Overt Aggression Scale and Ramsay Sedation Scale will be applied within 12 hours after the first dosage.
Read the detailed description
double-blind controlled trial to compare effectiveness of intramuscular olanzapine and ketamine as first medication to fast sedation of patients with agitation caused by psychiatric conditions. Randomization will be performed by permuted blocks allocation in which ketiamine or olanzapine standard treatment will be assigned to blocks of five patients and distributed in this order: olanzapine and ketiamine. This assignment will be repeated until the total number of subjects (500) be reached.
agitation status will be operationalized using Overt Agitation Severity Scale Total Score (OASS) equal or greater than 20 and Overt Aggressive Scale (OAS) with four or more positive items. Full physical and neurological examination will be completed as soon as possible, whenever patient is considered eligible for the study. Written Informed consent should be provided before and after participating in this study, and should be reviewed and approved by the institutional review board. Written consent obtained before admission to the emergency ward by legal guardian and after 12 hours by the patient (whenever he or she is is able to understand the information) or by the guardian. This study will comply with principles of the Declaration of Helsinki and Good Clinical Practice and approved by the Institutional Review Board (IRB) of Hospital Larcade of San Miguel County (Province of Buenos AIres (Project msm001) inter-rater reproducibility will be evaluated by two raters which will repeatedly apply OASS, OAS and RSS to patients admitted to the emergency room before the study until the intraclass correlation coefficient (ICC) reach a score of 0.80 or greater medications will be packaged in identical color-coded boxes and dosage of of olanzapine and ketiamine will be determined according to standard protocols and previous studies.
If a subject needs another intervention will be removed from the study. subjects will be assessed from 1 to 12 hours after administration of selected medication.
psychiatrists will be masked to patient's treatment assignment, and patients will be instructed not to reveal current treatment to investigators.
clinical safety of treatment will be assessed by notification and with an close-ended inquiry into adverse events together with full physical examination and vital signs measurements. Statistical analyses mean and standard deviation (SD) and comparisons of baseline demographic and clinical characteristics with one-way analysis of variance (ANOVA), chi-square test for categorical variables and mixed-effect analyses of covariance (ANCOVAs) with medication (olanzapine, ketiamine) as between-groups factor and time (1 hour, 2 hours, 4 hours, 6 hours and 12 hours) as a within-group factor. OASS at time zero, OAS at time zero, and presence of excessive sedation will be fixe covariates, and symptom ratings (OASS, OAS and RSS) will be time-varying covariates.
differences between groups at each time point and variance with post-hoc Duncan's tests will be calculated to compare mean OASS, OAS and RSS scores between groups.
- Being tested
- Ketamine
- Keywords
- Psychomotor agitation; Tranquilizing agents
- Medical subject headings
- Psychomotor Agitation, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called olanzapine
study medications were packaged in identical color-coded boxes. first dosage included either 10 mg of olanzapine, or 10 mg of ketamine Dosages were chosen based on previous studies After the initial dose, no additional dosis were allowed if supplemental medication eas needed according to clinician judgment the subject will be immediately removed from the study.
All subjects will be assessed 1 hour, 2 hours, 4 hours, 6 hours and 12 hours after t he first administration of the medication.
| Study group | Role | What they receive |
|---|---|---|
| ketamine | Active comparator | assessment of agitation status with Ramsay Sedation Scale administration of ketamine 10 mg / ml IM one dose supervision of vital signs registration of time of ketamine administration registration of time when expected outcome is obtained follow up of vital signs supervision until obsevation period expires (12 hours after admission to emergency board) registration of adverse effects registration if other interventions were applied (aside of ketamine administration) withdrawal of patient from the study if other medication was needed (aside of ketamine) Receives: Drug: Ketamine |
| olanzapine | Active comparator | assessment of agitation status with Ramsay Sedation Scale administration of olanzapine 10 mg / ml IM one dose supervision of vital signs registration of time of olanzapine administration registration of time when expected outcome is obtained follow up of vital signs supervision until obsevation period expires (12 hours after admission to emergency board) registration of adverse effects registration if other interventions were applied (aside of olanzapine administration) withdrawal of patient from the study if other medication was needed (aside of olanzapine) Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
sedation status
subjects will be assessed 1 hour, 2 hours, 4 hours, 6 hours and 12 hours after administration of the medication with Ramsay Sedation Scale score (RSS).
Measured: 1 to 12 hours
Secondary outcomes (1)
adverse effects
extrapirarmidal effects with Angus Scale for extrapiramidal movements excessive sedation with Ramsay Sedation Scale score paradoxical agitation with Ramsay Sedation Scale Score
Measured: 1 to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start1 Jan 2015
- Primary completion1 Jan 2016
- Study completion31 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychomotor AgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind controlled trial to compare the effectiveness of intramuscular olanzapine and ketamine as first medication(s) used to treat patients with agitation caused by psychosis.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Rosario
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, daniel serrani, Universidad Nacional de Rosario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216941
- Sponsor's protocol ID
- msm1
- Acronym
- IM-OK-FAST
- Status last verified
- Jul 2017
- First submitted
- 10 Jul 2017
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: make accesible patients data on SPSS file formats with not personal ID data
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Double Blind Trial of Ketiapine and Olanzapine Comparative Efficacy for Fast Sedation of Severely Agitated Patients in Emergency Psychiatric Ward
- ClinicalTrials.gov ID
- NCT03216941
- Acronym / sponsor ID
- IM-OK-FAST / msm1
- Keywords
- Psychomotor agitation; Tranquilizing agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Universidad Nacional de RosarioUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 31 Jan 2016 (actual)
- First posted
- 13 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
comparison of intramuscular olanzapine and ketamine efficacy as first medication for fast sedation of patients with agitation and aggressive behavior. Five hundred patients with agitation caused by psychiatric disorder were randomly assigned under double-blind conditions to receive olanzapine or ketiapine. The Overt Agitation Severity Scale, Overt Aggression Scale and Ramsay Sedation Scale will be applied within 12 hours after the first dosage.
Detailed description
double-blind controlled trial to compare effectiveness of intramuscular olanzapine and ketamine as first medication to fast sedation of patients with agitation caused by psychiatric conditions. Randomization will be performed by permuted blocks allocation in which ketiamine or olanzapine standard treatment will be assigned to blocks of five patients and distributed in this order: olanzapine and ketiamine. This assignment will be repeated until the total number of subjects (500) be reached.
agitation status will be operationalized using Overt Agitation Severity Scale Total Score (OASS) equal or greater than 20 and Overt Aggressive Scale (OAS) with four or more positive items. Full physical and neurological examination will be completed as soon as possible, whenever patient is considered eligible for the study. Written Informed consent should be provided before and after participating in this study, and should be reviewed and approved by the institutional review board. Written consent obtained before admission to the emergency ward by legal guardian and after 12 hours by the patient (whenever he or she is is able to understand the information) or by the guardian. This study will comply with principles of the Declaration of Helsinki and Good Clinical Practice and approved by the Institutional Review Board (IRB) of Hospital Larcade of San Miguel County (Province of Buenos AIres (Project msm001) inter-rater reproducibility will be evaluated by two raters which will repeatedly apply OASS, OAS and RSS to patients admitted to the emergency room before the study until the intraclass correlation coefficient (ICC) reach a score of 0.80 or greater medications will be packaged in identical color-coded boxes and dosage of of olanzapine and ketiamine will be determined according to standard protocols and previous studies.
If a subject needs another intervention will be removed from the study. subjects will be assessed from 1 to 12 hours after administration of selected medication.
psychiatrists will be masked to patient's treatment assignment, and patients will be instructed not to reveal current treatment to investigators.
clinical safety of treatment will be assessed by notification and with an close-ended inquiry into adverse events together with full physical examination and vital signs measurements. Statistical analyses mean and standard deviation (SD) and comparisons of baseline demographic and clinical characteristics with one-way analysis of variance (ANOVA), chi-square test for categorical variables and mixed-effect analyses of covariance (ANCOVAs) with medication (olanzapine, ketiamine) as between-groups factor and time (1 hour, 2 hours, 4 hours, 6 hours and 12 hours) as a within-group factor. OASS at time zero, OAS at time zero, and presence of excessive sedation will be fixe covariates, and symptom ratings (OASS, OAS and RSS) will be time-varying covariates.
differences between groups at each time point and variance with post-hoc Duncan's tests will be calculated to compare mean OASS, OAS and RSS scores between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- double-blind controlled trial to compare the effectiveness of intramuscular olanzapine and ketamine as first medication(s) used to treat patients with agitation caused by psychosis.
| Arm | Type | Receives |
|---|---|---|
| ketamine | Active comparator | Drug: Ketamineassessment of agitation status with Ramsay Sedation Scale administration of ketamine 10 mg / ml IM one dose supervision of vital signs registration of time of ketamine administration registration of time when expected outcome is obtained follow up of vital signs supervision until obsevation period expires (12 hours after admission to emergency board) registration of adverse effects registration if other interventions were applied (aside of ketamine administration) withdrawal of patient from the study if other medication was needed (aside of ketamine) |
| olanzapine | Active comparator | Drug: Ketamineassessment of agitation status with Ramsay Sedation Scale administration of olanzapine 10 mg / ml IM one dose supervision of vital signs registration of time of olanzapine administration registration of time when expected outcome is obtained follow up of vital signs supervision until obsevation period expires (12 hours after admission to emergency board) registration of adverse effects registration if other interventions were applied (aside of olanzapine administration) withdrawal of patient from the study if other medication was needed (aside of olanzapine) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- signs of agitation,
- age between 18 and 64 years,
- bipolar (maniac or mixed episode)
- psychotic disorder diagnosis
- disorders due to drug abuse,
Key exclusion criteria (4 listed)
- failure to agree to participate in the study,
- incapability of completing all steps
- unstable clinical disease -
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineAlso: olanzapinestudy medications were packaged in identical color-coded boxes. first dosage included either 10 mg of olanzapine, or 10 mg of ketamine Dosages were chosen based on previous studies After the initial dose, no additional dosis were allowed if supplemental medication eas needed according to clinician judgment the subject will be immediately removed from the study. All subjects will be assessed 1 hour, 2 hours, 4 hours, 6 hours and 12 hours after t he first administration of the medication. | Drug | ketamine, olanzapine |
Primary outcome
sedation status
Time frame: 1 to 12 hours
subjects will be assessed 1 hour, 2 hours, 4 hours, 6 hours and 12 hours after administration of the medication with Ramsay Sedation Scale score (RSS).
1 secondary outcome
adverse effects
Time frame: 1 to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- Individual participant dataSharing planned: Undecided. make accesible patients data on SPSS file formats with not personal ID data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine in people with Psychomotor Agitation and Psychiatric Disorder, run by Universidad Nacional de Rosario at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sedation status (time frame: 1 to 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2017.