Neurologic DisorderOPOSSUMNCT04726449
Observatory of Psychiatric Symptoms and Their Somatic Causes in Urgent Medical Care
An observational study of Neurologic Disorder and Psychiatric Disorder, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Use of emergency department for psychiatric symptoms always addresses the question of a potential somatic cause to the symptoms. Despite the wide-spread use of standard biology test and systematic brain imaging (for a first episode), there are still up to 5% of patients sent in psychiatric wards that actually have a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurologic Disorder, Psychiatric Disorder
- What is being tested?
- Screening for acute confusional state
- How many people
- 148 participants
- Where
- 1 siteFrance
- Study dates
- 11 May 2021to 8 May 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient using emergency department for a psychiatric symptom
Who may be able to join
- Age> 18 years old
- Patient consulting the emergency room for psychiatric recourse
- Benefiting from a consultation with a psychiatrist in the emergency room
- Patient affiliated to a social security scheme
Who cannot join
- Pregnant or breastfeeding women
- Patient objecting to the conduct of this study and the collection of health data
- Patient with motor disorders preventing the performance of a test requiring a pencil
- Patient sedated before treatment in the emergency room
- Patient with visual disturbances
Trial locations and contacts
1 site in 1 country.
France1 site
Service Accueil des Urgences, Hopital Edouard Herriot
Lyon, Rhône, 69003
About this study
Official title: Observatory of Psychiatric Symptoms and Their Somatic Causes in Urgent Medical Care (OPOSSUM)
Use of emergency department for psychiatric symptoms always addresses the question of a potential somatic cause to the symptoms. Despite the wide-spread use of standard biology test and systematic brain imaging (for a first episode), there are still up to 5% of patients sent in psychiatric wards that actually have a somatic explanation to their symptoms which induces an important delay in the diagnostic assessement We hypothesized that simple neurological clinical examination along with fast psychometric screening tests in the Emergency Room (ER) could help the physicians to better screen the patients and thus prevent inaccurate post-emergency orientation.
Every patient visiting the ER for psychiatric symptoms will be included. The usual physical examination by the ER physician will be associated with two psychometric tests (namely the Clock-drawing test and Frontal Assessment Battery test).
The follow up will be made after 3 months in order to have the final diagnosis. Neurological data and data from the FAB test and the Clock-drawing test will be compared between patients who were finally given a psychiatric diagnosis versus patients with a somatic diagnosis at the end of the follow up period.
- Conditions
- Neurologic Disorder, Psychiatric Disorder
- Being tested
- Screening for acute confusional state
- Medical subject headings
- Nervous System Diseases, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening for acute confusional stateOther
The intervention will consist of two psychometric test to screen for acute confusional state with the usual physical examination by the emergency physician. The neurological examination abnormalities will be noted
| Study group | Role | What they receive |
|---|---|---|
| psychiatric diagnosis | psychiatric diagnosis : patients who were given a psychiatric diagnosis at the end of the follow up Receives: Other: Screening for acute confusional state | |
| somatic diagnosis | somatic diagnosis: patients who were given a somatic diagnosis at the end of the follow up Receives: Other: Screening for acute confusional state |
What is being measured
The primary outcome is the main question the study is designed to answer.
Somatic or psychiatric nature of the final diagnosis given to the patient
interview patient to collect during the last 90 days the data of a hospitalization, its possible duration, the examinations that may have been necessary to obtain the diagnosis: blood, urine, Cerebrospinal Fluid, imaging exams, electroencephalography.
Measured: At 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start11 May 2021
- Primary completion8 May 2024
- Study completion8 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic DisorderStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- KARIM TAZAROURTE, MD, PhD, Principal investigator, Hôpital Edouard Herriot, HCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726449
- Sponsor's protocol ID
- 69HCL20_1071
- Acronym
- OPOSSUM
- Status last verified
- Jul 2023
- First submitted
- 22 Jan 2021
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observatory of Psychiatric Symptoms and Their Somatic Causes in Urgent Medical Care (OPOSSUM)
- ClinicalTrials.gov ID
- NCT04726449
- Acronym / sponsor ID
- OPOSSUM / 69HCL20_1071
- Conditions
- Neurologic Disorder, Psychiatric Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 11 May 2021 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 27 Jan 2021 (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.
Use of emergency department for psychiatric symptoms always addresses the question of a potential somatic cause to the symptoms. Despite the wide-spread use of standard biology test and systematic brain imaging (for a first episode), there are still up to 5% of patients sent in psychiatric wards that actually have a somatic explanation to their symptoms which induces an important delay in the diagnostic assessement We hypothesized that simple neurological clinical examination along with fast psychometric screening tests in the Emergency Room (ER) could help the physicians to better screen the patients and thus prevent inaccurate post-emergency orientation.
Every patient visiting the ER for psychiatric symptoms will be included. The usual physical examination by the ER physician will be associated with two psychometric tests (namely the Clock-drawing test and Frontal Assessment Battery test).
The follow up will be made after 3 months in order to have the final diagnosis. Neurological data and data from the FAB test and the Clock-drawing test will be compared between patients who were finally given a psychiatric diagnosis versus patients with a somatic diagnosis at the end of the follow up period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| psychiatric diagnosis | – | Other: Screening for acute confusional statepsychiatric diagnosis : patients who were given a psychiatric diagnosis at the end of the follow up |
| somatic diagnosis | – | Other: Screening for acute confusional statesomatic diagnosis: patients who were given a somatic diagnosis at the end of the follow up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient using emergency department for a psychiatric symptom
Key inclusion criteria (4 listed)
- Age> 18 years old
- Patient consulting the emergency room for psychiatric recourse
- Benefiting from a consultation with a psychiatrist in the emergency room
- Patient affiliated to a social security scheme
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding women
- Patient objecting to the conduct of this study and the collection of health data
- Patient with motor disorders preventing the performance of a test requiring a pencil
- Patient sedated before treatment in the emergency room
- Patient with visual disturbances
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 |
|---|---|---|
| Screening for acute confusional stateThe intervention will consist of two psychometric test to screen for acute confusional state with the usual physical examination by the emergency physician. The neurological examination abnormalities will be noted | Other | psychiatric diagnosis, somatic diagnosis |
Primary outcome
Somatic or psychiatric nature of the final diagnosis given to the patient
Time frame: At 3 month
interview patient to collect during the last 90 days the data of a hospitalization, its possible duration, the examinations that may have been necessary to obtain the diagnosis: blood, urine, Cerebrospinal Fluid, imaging exams, electroencephalography.
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 7 Jun 2024.
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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.
KARIM TAZAROURTE, MD, PhD principal investigator
Hôpital Edouard Herriot, HCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurologic Disorder and Psychiatric Disorder, run by Hospices Civils de Lyon at 1 site in France.
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 4 inclusion and 5 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 7 Jun 2024. 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 France. 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.
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?
Somatic or psychiatric nature of the final diagnosis given to the patient (time frame: At 3 month). 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 7 Jun 2024.