Depressive DisorderCAPANCT03509077
Study of Addiction Criteria in the Elderly
An observational study of Depressive Disorder, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Patients over 65 years old who are exposed to alcohol or benzodiazepines will be recruited through the Fragility Assessment and Addictions Prevention Day Hospital, the Addiction Service and the Geriatric Post-Emergency Department. Toulouse University Hospital. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Depressive Disorder
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2018to 19 Jun 2019
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Three groups of patients will be recruited in three departments of the University Hospital of Toulouse: 1. Patients meeting the criteria for frailty will be recruited to the Fragility Assessment and Addiction Prevention Day Hospital. 2. Patients over 65, addicts and consultant in a specialized service. 3. Patients who have decompensated their fragility criteria will be recruited from the geriatric post-emergency department of Toulouse University Hospital.
Who may be able to join
- To be over 65
- Have given your non-oral opposition to participate in research
- Mini-Mental State Examination (MMSE) greater than or equal to 24
- Be part of one of the 3 inclusion services of the University Hospital of Toulouse
- For 12 months, have daily consumption of benzodiazepine (at least once a day) and / or have excessive alcohol consumption as recommended by the American Geriatric Society (more than one unit of alcohol per day) ).
Who cannot join
- Patient refusing to participate in the study
- MMSE less than 24
- Acute decompensation of a psychiatric disorder
- Impossibility to understand or speak French
- Patient under the protection of justice
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital Toulouse
Toulouse, 31059
Juliette Salles, MD, 05 34 55 75 24 ext. 33, salles.j@chu-toulouse.fr
Isabelle Olivier, PhD, 05 61 77 70 51 ext. 33, olivier.i@chu-toulouse.fr
About this study
Patients over 65 years old who are exposed to alcohol or benzodiazepines will be recruited through the Fragility Assessment and Addictions Prevention Day Hospital, the Addiction Service and the Geriatric Post-Emergency Department. Toulouse University Hospital.
The investigators will study descriptively the frequency of substance use disorder and the frequency of DSM-5 criteria associated with this diagnosis in a population of elderly subjects.
Read the detailed description
The hypothesis of this research is that some of the DSM-5 criteria for substance use disorder are more appropriate than others in people over 65 years of age. This study therefore aims to describe the frequency of the DSM-5 criteria for the substance use disorder in a population over 65 years of age and to link it secondarily to the severity of the addiction.
The study is a descriptive study of a population of subjects over 65 years old. It aims to search for addiction criteria in this population by formulating the hypothesis of an addictive vulnerability relating to certain risk factors.
To sensitize the detection of criteria, we chose among older subjects those who are most at risk because they are more exposed to the vulnerability factor relative to this population (physical disability, loss of autonomy, loneliness).
- Conditions
- Depressive Disorder
- Keywords
- geriatric, addiction
- Medical subject headings
- Depressive Disorder, Behavior, Addictive
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of DSM-5 criteria
The number of DSM-5 criteria for substance use disorder in the patient assessment.
The number of DSM-5 criteria is a method of problematic substance use leading to clinically significant impairment or impairment characterized by the presence of at least two of the following manifestations over a 12-month period
Measured: 1 hour
Secondary outcomes (1)
The Mini-GDS : a screening tool
The diagnosis of depression will be made using a screening tool, the Mini-GDS, performed in routine clinical practice as part of the assessment at the day hospital for frailty and addiction prevention.
The Mini-GDS includes 4 items rated at one point depending on the answer. A higher score 1 makes it possible to suspect the existence of a depression.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start19 Jun 2018
- Primary completion19 Jun 2019 (estimated)
- Study completion19 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juliette Salles, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509077
- Sponsor's protocol ID
- RC31/18/0046
- Other IDs
- 2018-A00905-50
- Acronym
- CAPA
- Status last verified
- Apr 2019
- First submitted
- 16 Apr 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Addiction Criteria in the Elderly
- ClinicalTrials.gov ID
- NCT03509077
- Acronym / sponsor ID
- CAPA / RC31/18/0046
- Conditions
- Depressive Disorder
- Keywords
- geriatric, addiction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 19 Jun 2019 (estimated)
- Study completion
- 19 Jun 2019 (estimated)
- First posted
- 26 Apr 2018 (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.
Patients over 65 years old who are exposed to alcohol or benzodiazepines will be recruited through the Fragility Assessment and Addictions Prevention Day Hospital, the Addiction Service and the Geriatric Post-Emergency Department. Toulouse University Hospital.
The investigators will study descriptively the frequency of substance use disorder and the frequency of DSM-5 criteria associated with this diagnosis in a population of elderly subjects.
Detailed description
The hypothesis of this research is that some of the DSM-5 criteria for substance use disorder are more appropriate than others in people over 65 years of age. This study therefore aims to describe the frequency of the DSM-5 criteria for the substance use disorder in a population over 65 years of age and to link it secondarily to the severity of the addiction.
The study is a descriptive study of a population of subjects over 65 years old. It aims to search for addiction criteria in this population by formulating the hypothesis of an addictive vulnerability relating to certain risk factors.
To sensitize the detection of criteria, we chose among older subjects those who are most at risk because they are more exposed to the vulnerability factor relative to this population (physical disability, loss of autonomy, loneliness).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Three groups of patients will be recruited in three departments of the University Hospital of Toulouse: 1. Patients meeting the criteria for frailty will be recruited to the Fragility Assessment and Addiction Prevention Day Hospital. 2. Patients over 65, addicts and consultant in a specialized service. 3. Patients who have decompensated their fragility criteria will be recruited from the geriatric post-emergency department of Toulouse University Hospital.
Key inclusion criteria (5 listed)
- To be over 65
- Have given your non-oral opposition to participate in research
- Mini-Mental State Examination (MMSE) greater than or equal to 24
- Be part of one of the 3 inclusion services of the University Hospital of Toulouse
- For 12 months, have daily consumption of benzodiazepine (at least once a day) and / or have excessive alcohol consumption as recommended by the American Geriatric Society (more than one unit of alcohol per day) ).
Key exclusion criteria (5 listed)
- Patient refusing to participate in the study
- MMSE less than 24
- Acute decompensation of a psychiatric disorder
- Impossibility to understand or speak French
- Patient under the protection of justice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number of DSM-5 criteria
Time frame: 1 hour
The number of DSM-5 criteria for substance use disorder in the patient assessment. The number of DSM-5 criteria is a method of problematic substance use leading to clinically significant impairment or impairment characterized by the presence of at least two of the following manifestations over a 12-month period
1 secondary outcome
The Mini-GDS : a screening tool
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Juliette Salles, MD principal investigator
University Hospital, Toulouse
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 Depressive Disorder, run by University Hospital, Toulouse 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 5 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: status not confirmed, as of the sponsor's last update on 18 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juliette Salles, MD (05 34 55 75 24 ext. 33, salles.j@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of DSM-5 criteria (time frame: 1 hour). 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 18 Apr 2019.