Psychiatric Disorder Clinical Trial
— IM-OK-FASTOfficial title:
Prospective Randomised Double Blind Trial of Ketiapine and Olanzapine Comparative Efficacy for Fast Sedation of Severely Agitated Patients in Emergency Psychiatric Ward
Verified date | July 2017 |
Source | Universidad Nacional de Rosario |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Argentina | hospital Larcade | San Miguel | Buenos Aires |
Lead Sponsor | Collaborator |
---|---|
Universidad Nacional de Rosario |
Argentina,
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 |
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
|