Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03216941
Other study ID # msm1
Secondary ID
Status Completed
Phase Phase 4
First received July 10, 2017
Last updated July 11, 2017
Start date January 1, 2015
Est. completion date January 31, 2016

Study information

Verified date July 2017
Source Universidad Nacional de Rosario
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. The Overt Agitation Severity Scale, Overt Aggression Scale and Ramsay Sedation Scale will be applied within 12 hours after the first dosage.


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.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date January 31, 2016
Est. primary completion date January 1, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Drug:
Ketamine
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.

Locations

Country Name City State
Argentina hospital Larcade San Miguel Buenos Aires

Sponsors (1)

Lead Sponsor Collaborator
Universidad Nacional de Rosario

Country where clinical trial is conducted

Argentina, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 1 to 12 hours
Secondary adverse effects extrapirarmidal effects with Angus Scale for extrapiramidal movements excessive sedation with Ramsay Sedation Scale score paradoxical agitation with Ramsay Sedation Scale Score 1 to 24 hours
See also
  Status Clinical Trial Phase
Completed NCT03409991 - Testing the Efficacy of Opening Doors: A Career Guidance Intervention for Individuals With Psychiatric Disabilities N/A
Not yet recruiting NCT05316948 - Mental Health and Sexuality in Adolescents and Young Adults
Completed NCT04778163 - The Use of Humor With Young Adults in Psychiatric Care N/A
Not yet recruiting NCT06304363 - Braining - Evaluation of Acute Effects of Physical Exercise N/A
Recruiting NCT04096625 - Enhancement of a Psychotherapeutic Intervention Through Transcranial Direct Current Stimulation (tDCS) N/A
Terminated NCT06012981 - Psychological Treatment in Psychiatric Inpatient Care N/A
Not yet recruiting NCT05930353 - Psychometric Validation of a French-language Version of the PERMA-Profiler: Tools for Assessing Multidimensional Subjective Well-being
Completed NCT04099173 - A Brief Mindfulness-Based Intervention for Suicidal Ideation N/A
Completed NCT01866956 - Computerized Screening for Comorbidity in Adolescents With Substance or Psychiatric Disorders
Recruiting NCT04249960 - Sustain and Reinforce the Transition From Child to Adult Mental Health Care in Switzerland : A Monocentric Nested Cohort Randomized Controlled Trial: The SORT Study. N/A
Recruiting NCT05962424 - HNC: Human Neural Circuits Electrophysiology During Cognition Phase 1
Recruiting NCT06092866 - Digital Versus Telephone Symptom Assessment and Triage in Primary Care N/A
Recruiting NCT03678194 - Treating Depression on a Day-to-day Basis: Development of a Tool for Physicians Based on a Smartphone Application N/A
Completed NCT03748355 - Using Pharmacogenetics to Identify Patients With Polypharmacy at Risk of Medication Adverse Effects N/A
Completed NCT05473962 - Mid-Term Follow-up Assessment After Exposure to Natural Disaster
Recruiting NCT05577585 - Ketamine and Stress in OCD N/A
Completed NCT05124158 - COVID-19 Severity and Psychiatric Morbidity
Recruiting NCT05560581 - Digital Self-efficacy Training to Bridge Waiting Times for Psychotherapy N/A
Completed NCT04618250 - Improving Physical Health in Patients With Psychiatric Disorders in General Practice (SOFIA) N/A
Not yet recruiting NCT06014164 - Qualitative Study About Psychedelics Using in Psychiatric Disorders