Depression in Old AgeBZDNCT06107283
Study of the Reduction of the Prescriptions of Benzodiazepines and Related
An observational study of Depression in Old Age, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The significant consumption of Benzodiazepines and related drugs in the elderly outside of good practice recommendations is a major issue in the care of the elderly. Adverse effects have been the subject of numerous studies, leading to falls, addictions and even deaths. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Depression in Old Age
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2023to 17 Aug 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Major subject (≥ 75 years old) discharged from a geriatric Follow-up Care and Rehabilitation service for whom a reduction in the dosage of Benzodiazepines and related drugs was carried out during hospitalization and who returned home (individual or EHPAD) after hospitalization.
Who may be able to join
- Major subject (≥ 75 years old)
- Subject discharged from a geriatric Follow-up Care and Rehabilitation service for whom a reduction in the dosage of Benzodiazepines and related drugs was carried out during hospitalization and who returned home (individual or EHPAD) after hospitalization.
- Subject not opposing, after information, the reuse of their data for the purposes of this research.
Who cannot join
- Subject having expressed opposition to participating in the study.
- Subject having treatment with Benzodiazepine to prevent recurrence of epileptic seizures.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Gériatrie - Service de Soins de Soins Médicaux et de Réadaptation - CHU de Strasbourg - France
Strasbourg, 67091
Alexandre BOUSSUGE, MD, 33 3 88 11 54 61, alexandre.boussuge@chru-strasbourg.fr
Pierre WURTZ, MD, 33 3 88 11 54 61, pierre.wurtz@chru-strasbourg.fr
About this study
Official title: Study of the Reduction of the Prescriptions of Benzodiazepines and Related After the Discharge of a Service of Follow-up Care and Geriatric Rehabilitation
The significant consumption of Benzodiazepines and related drugs in the elderly outside of good practice recommendations is a major issue in the care of the elderly. Adverse effects have been the subject of numerous studies, leading to falls, addictions and even deaths. The general practitioner is often faced with long-term medication intake which is not consistent with a good benefit/risk balance, but stopping or reducing the dosage remains a problem in current practice.
The Aftercare and Geriatric Rehabilitation services due to their operation (several weeks of hospitalization) seek to adapt the patient's therapies in order to obtain the most convincing benefit/risk balance possible. A reduction or withdrawal of treatments with Benzodiazepines or related drugs are therefore frequently initiated.
Read the detailed description
The aim of this research is to quantify among the patients who benefited from a dosage reduction of Benzodiazepines and related drugs during a stay in the Geriatric Care and Aftercare and Rehabilitation department, the number of patients who had an increase of this treatment within 12 weeks following discharge from hospitalization.
- Conditions
- Depression in Old Age
- Keywords
- Depression in Old Age, Benzodiazepines drugs, Geriatrics
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients who had an increase in Benzodiazepines in the 12 weeks following discharge from hospitalization.
Measured: 12 weeks following discharge from hospitalization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Mar 2023
- Primary completionAug 2024 (estimated)
- Study completion17 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in Old AgeStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107283
- Sponsor's protocol ID
- 8787
- Acronym
- BZD
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 30 Oct 2023
- 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 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Reduction of the Prescriptions of Benzodiazepines and Related After the Discharge of a Service of Follow-up Care and Geriatric Rehabilitation
- ClinicalTrials.gov ID
- NCT06107283
- Acronym / sponsor ID
- BZD / 8787
- Conditions
- Depression in Old Age
- Keywords
- Depression in Old Age, Benzodiazepines drugs, Geriatrics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- 17 Aug 2024 (estimated)
- First posted
- 30 Oct 2023 (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.
The significant consumption of Benzodiazepines and related drugs in the elderly outside of good practice recommendations is a major issue in the care of the elderly. Adverse effects have been the subject of numerous studies, leading to falls, addictions and even deaths. The general practitioner is often faced with long-term medication intake which is not consistent with a good benefit/risk balance, but stopping or reducing the dosage remains a problem in current practice.
The Aftercare and Geriatric Rehabilitation services due to their operation (several weeks of hospitalization) seek to adapt the patient's therapies in order to obtain the most convincing benefit/risk balance possible. A reduction or withdrawal of treatments with Benzodiazepines or related drugs are therefore frequently initiated.
Detailed description
The aim of this research is to quantify among the patients who benefited from a dosage reduction of Benzodiazepines and related drugs during a stay in the Geriatric Care and Aftercare and Rehabilitation department, the number of patients who had an increase of this treatment within 12 weeks following discharge from hospitalization.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Major subject (≥ 75 years old) discharged from a geriatric Follow-up Care and Rehabilitation service for whom a reduction in the dosage of Benzodiazepines and related drugs was carried out during hospitalization and who returned home (individual or EHPAD) after hospitalization.
Key inclusion criteria (3 listed)
- Major subject (≥ 75 years old)
- Subject discharged from a geriatric Follow-up Care and Rehabilitation service for whom a reduction in the dosage of Benzodiazepines and related drugs was carried out during hospitalization and who returned home (individual or EHPAD) after hospitalization.
- Subject not opposing, after information, the reuse of their data for the purposes of this research.
Key exclusion criteria (2 listed)
- Subject having expressed opposition to participating in the study.
- Subject having treatment with Benzodiazepine to prevent recurrence of epileptic seizures.
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 patients who had an increase in Benzodiazepines in the 12 weeks following discharge from hospitalization.
Time frame: 12 weeks following discharge from hospitalization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
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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.
Gériatrie - Service de Soins de Soins Médicaux et de Réadaptation - CHU de Strasbourg - France
Strasbourg, France
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 Depression in Old Age, run by University Hospital, Strasbourg, France 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 3 inclusion and 2 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 30 Oct 2023. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients who had an increase in Benzodiazepines in the 12 weeks following discharge from hospitalization. (time frame: 12 weeks following discharge from hospitalization.). 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 30 Oct 2023.