Comparison of Therapeutic Strategies With Cholinesterase Inhibitors (SOS TRIAL)

October 5, 2023 updated by: University Hospital, Bordeaux

Comparison of Therapeutic Strategies With Cholinesterase Inhibitors: Stop or Still (SOS) Trial

Cholinesterase inhibitors (CI) remain the only drugs with a recognized efficacy in mild to moderate Alzheimer's disease (AD) in spite of enormous research efforts. However, these drugs presented as "symptomatic treatment" of AD are considered as having only a weak effect on the course of AD. The reimbursement of these drugs is regularly challenged due to the lack of evidence for the impact of these drugs on milestones stages of AD evolution (survival without severe dementia, restriction in Basic Activities of Daily Living - BADL) and on major consequences in public health (hospitalization and institutionalization). The great majority of previous randomized controlled trials conducted with CI have had a too short duration and the end points were limited to cognition (ADAS Cog scale), IADL (Instrumental Activities of Daily Living) function and Global Impression of Change. New evidences from the DOMINO trial (1) conducted in UK, independently of the pharmaceutical industry, showed that the true effect of CI might be more to avoid or to delay the cognitive or functional decline in AD than to improve patients; the institutionalisation (2) was also delayed. However, this trial was conducted in patients with moderate to severe AD, and the interest of the drugs at the mild to moderate stage remains questionable.

The investigators have shown that a good surrogate marker of survival without severe dementia would be an increase of ADAS Cog scale of more than six points (3). A post hoc reanalysis of the pivotal RCT with two CI showed that in mild to moderate patients, CI was associated with a 15% decrease of patients with a deterioration of ADAS-Cog of more than six points in six months. Thus at the beginning of dementia the real effect of CI might be more of delaying the cognitive and functional decline, than to improve the patients. The main objective of the SOS trial is to demonstrate that the benefit of CI at the early phase of dementia is the same as at the later phase.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1205

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France, 80054
      • Angers, France, 49933
        • CHU d'Angers Centre Mémoire Ressources Recherche
      • Bastia, France, 20604
        • CHU de Bastia Centre Mémoire Ressources Recherche
        • Contact:
      • Besançon, France, 25030
        • CHU de Besançon Centre Mémoire Ressources Recherche
      • Bordeaux, France, 33076
      • Brest, France, 29200
        • CHRU Cavale Blanche Service de Gériatrie
      • Bron, France, 69677
        • Service de Neuropsychologie Hôpital Neurologique Pierre Wertheimer
        • Contact:
      • Caen, France, 14033
        • CHU Côte de Nacre Service de neurologie et CMRR
      • Clermont-Ferrand, France, 63000
        • CHU de Clermont Ferrand Centre Mémoire Ressources Recherche
      • Colmar, France, 68000
        • Hôpital Pasteur Service de Neurologie
      • Dijon, France, 21679
      • Grenoble, France, 38043
        • Chu de Grenoble CMRR, Neurologie
        • Contact:
      • Lille, France, 59037
        • Hôpital Roger Salengro CMRR
      • Limoges, France, 87000
        • CHU Limoges Service de neurologie et CMRR
        • Contact:
      • Marseille, France
        • AP-HM
      • Montpellier, France, 34295
        • CHU Montpellier Hôpital Gui de Chauliac CMRR
        • Contact:
      • Nantes, France, 44093
      • Nice, France, 06100
        • Institut Claude Pompidou Centre Mémoire de Ressources et de Recherche
        • Contact:
      • Paris, France, 75013
      • Paris, France, 75013
        • Hôpital Universitaire de la Pitié Salpêtrière Pavillon François Lhermitte
        • Contact:
      • Paris, France, 75475
        • APHP Groupe Hospitalier Saint Louis Lariboisière Fernand Widal CMRR
        • Contact:
      • Poitiers, France, 86021
      • Reims, France, 51092
        • CHU Reims Hôpital Maison Blanche Court Séjour Gériatrique
        • Contact:
      • Rennes, France, 35033
        • CHU de Rennes - Hôpital Pontchaillou / Service de Neurologie
        • Contact:
      • Rouen, France, 76031
        • CHU de Rouen Hôpital Charles Nicolle Service Neurologie
        • Contact:
      • Saint-Étienne, France, 42055
      • Strasbourg, France, 67200
      • Toulouse, France
        • Centre de Recherche Clinique du Gérontopôle Cité de la Santé
      • Tours, France, 37000
        • CHRU de Bretonneau Unité de gérontopsychiatrie
        • Contact:
      • Vandoeuvre les nancy, France, 54511
        • CHU Nancy Service de Gériatrie-CMRR
        • Contact:
      • Villeurbanne, France, 69100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • New case of AD referring to a CMRR or MC.
  • Diagnosis of probable or possible AD, defined according to the NINCDS-ARDRA criteria
  • Mild to moderate stage, defined by a MMSE score above 15 at the time of pre-inclusion
  • Patients with indication to CI treatment
  • Patients Naïve to CI treatment
  • Patients aged 50 years or more
  • Menopause or effective contraception (for women)
  • Affiliated person or beneficiary of a social security scheme
  • Patients with AD LTI (Long Term Illeness)
  • Patients agree to participate, with free, informed and written consent signed by the patient and his caregiver

Non Inclusion Criteria:

  • Patients diagnosed with Lewy bodies disease, fronto-temporal dementia, or dementia from a cause other than Alzheimer Disease
  • More severe stage of the disease, defined by a MMSE equal or below 15 at the time of inclusion
  • Patients with contraindication to CI treatment
  • Patients residing in an institution at the time of pré-inclusion or randomization
  • Patients with a complete dependency for bathing and dressing at the time of pré-inclusion or randomization ( ADL de Katz, score 2/2 for the item "bathing" and/or "dressing")
  • Patients under tutorship or curatorship, patients unable to express consent
  • Patients with unstable severe general disease compromising the follow-up
  • Patients without caregiver
  • Patients included in another pharmacological trial
  • Pregnant or breastfeeding women

Exclusion Criteria:

  • CI responder patients for whom the MMSE score remained stable or became higher after 6 months of treatment
  • Patients with complete dependency for bathing and dressing at the randomization visit
  • Patients residing in an institution at the randomization visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group randomized for continuing treatment

Group who continues the cholinesterase inhibitors (CI). The treatment is one of the CI (donepezil, galantamine or rivastigmine) with market authorization and commercialized for more than 15 years in France. The choice of the treatment will be done by the specialist according to his habits; the specialist will monitor the treatment as usual.

All randomised patients will then be followed-up for two years with regular assessment of judgment criteria every 6 months.
Drug: cholinesterase inhibitors (CI) (donepezil, galantamine or rivastigmine)

The choice of the treatment will be done by the specialist according to his habits; the specialist will monitor the treatment as usual. All the recruited patients will be treated by CI according to the recommendations of the French HAS and the clinician's habits to choose the type of CI and adjust the dosage. After a 6-month period under CI treatment, patients will be classified according to the evolution of the Mini Mental State Examination (MMSE) as "non-responders" or responders.

Responders patients will continue their treatment according to the habits of the clinician. Non-responder patients will be included in the RCT, with individual randomization in two groups: one group who stops the CI, one group who continues the CI. All randomized patients will then be followed-up for two years with regular assessment of judgment criteria every 6 months.
No Intervention: Group randomized for stopping treatment
Group who stops the CI. No placebo will be given, over 2 years All randomised patients will then be followed-up for two years with regular assessment of judgment criteria every 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome is a combination of complete BADL dependency in bathing and dressing and/or institutionalization or death at 2 years after randomization.
Time Frame: at 30 months after patient's inclusion

Institutionalization with date of entry will be assessed by specialist at each follow-up time every 6 months. For patients not coming to the memory consultation, caregiver (formal and/or informal) and/or the general practitioner will be systematically contacted to obtain the information.

Death and date of death will be assessed by contacting proxy or general practitioner. In case of lack of information the birth City Hall will be contacted to assess the vital status.

For dependency in bathing and dressing, although it could be considered as less objective, we choose a level of total dependency, easy to assess with very low risk of misinterpretation.
at 30 months after patient's inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BADL dependency will be evaluated by the clinician using the BADL scale from Katz [17].
Time Frame: at inclusion

Each of the components of the combined primary outcome, as defined above, analyzed separately.

As previously demonstrated, bathing and dressing are the first ADL losses, also defined by Katz et al. as the thresholds of disability [17] [18]. A total limitation in bathing and dressing will be considered (each item is coded from 0 - no limitation, to 2 - total limitation).
at inclusion
BADL dependency will be evaluated by the clinician using the BADL scale from Katz [17].
Time Frame: at 6 months

Each of the components of the combined primary outcome, as defined above, analyzed separately.

As previously demonstrated, bathing and dressing are the first ADL losses, also defined by Katz et al. as the thresholds of disability [17] [18]. A total limitation in bathing and dressing will be considered (each item is coded from 0 - no limitation, to 2 - total limitation).
at 6 months
BADL dependency will be evaluated by the clinician using the BADL scale from Katz [17].
Time Frame: at 12 months
Each of the components of the combined primary outcome, as defined above, analyzed separately As previously demonstrated, bathing and dressing are the first ADL losses, also defined by Katz et al. as the thresholds of disability [17] [18]. A total limitation in bathing and dressing will be considered (each item is coded from 0 - no limitation, to 2 - total limitation).
at 12 months
BADL dependency will be evaluated by the clinician using the BADL scale from Katz [17].
Time Frame: at 18 months
Each of the components of the combined primary outcome, as defined above, analyzed separately As previously demonstrated, bathing and dressing are the first ADL losses, also defined by Katz et al. as the thresholds of disability [17] [18]. A total limitation in bathing and dressing will be considered (each item is coded from 0 - no limitation, to 2 - total limitation).
at 18 months
BADL dependency will be evaluated by the clinician using the BADL scale from Katz [17].
Time Frame: at 24 months
Each of the components of the combined primary outcome, as defined above, analyzed separately As previously demonstrated, bathing and dressing are the first ADL losses, also defined by Katz et al. as the thresholds of disability [17] [18]. A total limitation in bathing and dressing will be considered (each item is coded from 0 - no limitation, to 2 - total limitation).
at 24 months
BADL dependency will be evaluated by the clinician using the BADL scale from Katz [17].
Time Frame: at 30 months
Each of the components of the combined primary outcome, as defined above, analyzed separately As previously demonstrated, bathing and dressing are the first ADL losses, also defined by Katz et al. as the thresholds of disability [17] [18]. A total limitation in bathing and dressing will be considered (each item is coded from 0 - no limitation, to 2 - total limitation).
at 30 months
Combination of complete BADL dependency in bathing and dressing and/or institutionalization or death
Time Frame: at inclusion

Institutionalization with date of entry will be assessed by specialist at each follow-up time every 6 months. For patients not coming to the memory consultation, caregiver (formal and/or informal) and/or the general practitioner will be systematically contacted to obtain the information.

Death and date of death will be assessed by contacting proxy or general practitioner. In case of lack of information the birth City Hall will be contacted to assess the vital status.

For dependency in bathing and dressing, although it could be considered as less objective, we choose a level of total dependency, easy to assess with very low risk of misinterpretation.
at inclusion
Combination of complete BADL dependency in bathing and dressing and/or institutionalization or death
Time Frame: at 6 months

Institutionalization with date of entry will be assessed by specialist at each follow-up time every 6 months. For patients not coming to the memory consultation, caregiver (formal and/or informal) and/or the general practitioner will be systematically contacted to obtain the information.

Death and date of death will be assessed by contacting proxy or general practitioner. In case of lack of information the birth City Hall will be contacted to assess the vital status.

For dependency in bathing and dressing, although it could be considered as less objective, we choose a level of total dependency, easy to assess with very low risk of misinterpretation.
at 6 months
Combination of complete BADL dependency in bathing and dressing and/or institutionalization or death
Time Frame: at 12 months

Institutionalization with date of entry will be assessed by specialist at each follow-up time every 6 months. For patients not coming to the memory consultation, caregiver (formal and/or informal) and/or the general practitioner will be systematically contacted to obtain the information.

Death and date of death will be assessed by contacting proxy or general practitioner. In case of lack of information the birth City Hall will be contacted to assess the vital status.

For dependency in bathing and dressing, although it could be considered as less objective, we choose a level of total dependency, easy to assess with very low risk of misinterpretation.
at 12 months
Combination of complete BADL dependency in bathing and dressing and/or institutionalization or death
Time Frame: at 18 months

Institutionalization with date of entry will be assessed by specialist at each follow-up time every 6 months. For patients not coming to the memory consultation, caregiver (formal and/or informal) and/or the general practitioner will be systematically contacted to obtain the information.

Death and date of death will be assessed by contacting proxy or general practitioner. In case of lack of information the birth City Hall will be contacted to assess the vital status.

For dependency in bathing and dressing, although it could be considered as less objective, we choose a level of total dependency, easy to assess with very low risk of misinterpretation.
at 18 months
Combination of complete BADL dependency in bathing and dressing and/or institutionalization or death
Time Frame: at 24 months

Institutionalization with date of entry will be assessed by specialist at each follow-up time every 6 months. For patients not coming to the memory consultation, caregiver (formal and/or informal) and/or the general practitioner will be systematically contacted to obtain the information.

Death and date of death will be assessed by contacting proxy or general practitioner. In case of lack of information the birth City Hall will be contacted to assess the vital status.

For dependency in bathing and dressing, although it could be considered as less objective, we choose a level of total dependency, easy to assess with very low risk of misinterpretation.
at 24 months
Combination of complete BADL dependency in bathing and dressing and/or institutionalization or death
Time Frame: at 30 months

Institutionalization with date of entry will be assessed by specialist at each follow-up time every 6 months. For patients not coming to the memory consultation, caregiver (formal and/or informal) and/or the general practitioner will be systematically contacted to obtain the information.

Death and date of death will be assessed by contacting proxy or general practitioner. In case of lack of information the birth City Hall will be contacted to assess the vital status.

For dependency in bathing and dressing, although it could be considered as less objective, we choose a level of total dependency, easy to assess with very low risk of misinterpretation.
at 30 months
Institutionalization with date of entry
Time Frame: at inclusion
Institutionalization with date of entry will be assessed by specialist at each follow-up time every 6 months. For patients not coming to the memory consultation, caregiver (formal and/or informal) and/or the general practitioner will be systematically contacted to obtain the information.
at inclusion
Institutionalization with date of entry
Time Frame: at 6 months
Institutionalization with date of entry will be assessed by specialist at each follow-up time every 6 months. For patients not coming to the memory consultation, caregiver (formal and/or informal) and/or the general practitioner will be systematically contacted to obtain the information.
at 6 months
Institutionalization with date of entry
Time Frame: at 12 months
Institutionalization with date of entry will be assessed by specialist at each follow-up time every 6 months. For patients not coming to the memory consultation, caregiver (formal and/or informal) and/or the general practitioner will be systematically contacted to obtain the information.
at 12 months
Institutionalization with date of entry
Time Frame: at 18 months
Institutionalization with date of entry will be assessed by specialist at each follow-up time every 6 months. For patients not coming to the memory consultation, caregiver (formal and/or informal) and/or the general practitioner will be systematically contacted to obtain the information.
at 18 months
Institutionalization with date of entry
Time Frame: at 24 months
Institutionalization with date of entry will be assessed by specialist at each follow-up time every 6 months. For patients not coming to the memory consultation, caregiver (formal and/or informal) and/or the general practitioner will be systematically contacted to obtain the information.
at 24 months
Institutionalization with date of entry
Time Frame: at 30 months
Institutionalization with date of entry will be assessed by specialist at each follow-up time every 6 months. For patients not coming to the memory consultation, caregiver (formal and/or informal) and/or the general practitioner will be systematically contacted to obtain the information.
at 30 months
Death and date of death
Time Frame: at inclusion
Death and date of death will be assessed by contacting proxy or general practitioner. In case of lack of information the birth City Hall will be contacted to assess the vital status.
at inclusion
Death and date of death
Time Frame: at 6 months
Death and date of death will be assessed by contacting proxy or general practitioner. In case of lack of information the birth City Hall will be contacted to assess the vital status.
at 6 months
Death and date of death
Time Frame: at 12 months
Death and date of death will be assessed by contacting proxy or general practitioner. In case of lack of information the birth City Hall will be contacted to assess the vital status.
at 12 months
Death and date of death
Time Frame: at 18 months
Death and date of death will be assessed by contacting proxy or general practitioner. In case of lack of information the birth City Hall will be contacted to assess the vital status.
at 18 months
Death and date of death
Time Frame: at 24 months
Death and date of death will be assessed by contacting proxy or general practitioner. In case of lack of information the birth City Hall will be contacted to assess the vital status.
at 24 months
Death and date of death
Time Frame: at 30 months
Death and date of death will be assessed by contacting proxy or general practitioner. In case of lack of information the birth City Hall will be contacted to assess the vital status.
at 30 months
the ADL scale
Time Frame: at inclusion

ADL DE KATZ BATHING :└-┘/2 0 bathes self completely

  1. needs help in bathing only one part of the body
  2. needs help with bathing more than one part of the body or not bathed DRESSING :└-┘ /2

0 gets clothes and gets completely dressed without assistance

1 gets clothes and gets dressed without assistance, except for assistance in tying shoes 2 receives assistance in getting clothes or in getting dressed, or stays partly or completely undressed TOILETING :└-┘/2 0 toileting without assistance (may use cane, walker, or wheelchair)

1 receives assistance 2 doesn't go to room termed " toilet ". TRANSFER:└-┘/2 0 transfer without assistance (may be using cane or walker)

  1. transfer with assistance
  2. doesn't get out of bed. FEEDING :└-┘/2

0 feeding without help

  1. need help cutting meat or buttering bread
  2. needs total help or requires parenteral feeding. TOTAL : └-┴-┘/10 If the patient has a result of 2 at bathing and or dressing he can't be included at T0.
at inclusion
the ADL scale
Time Frame: at 6 months

ADL DE KATZ BATHING :└-┘/2 0 bathes self completely

  1. needs help in bathing only one part of the body
  2. needs help with bathing more than one part of the body or not bathed DRESSING :└-┘ /2

0 gets clothes and gets completely dressed without assistance

1 gets clothes and gets dressed without assistance, except for assistance in tying shoes 2 receives assistance in getting clothes or in getting dressed, or stays partly or completely undressed TOILETING :└-┘/2 0 toileting without assistance (may use cane, walker, or wheelchair)

1 receives assistance 2 doesn't go to room termed " toilet ". TRANSFER:└-┘/2 0 transfer without assistance (may be using cane or walker)

  1. transfer with assistance
  2. doesn't get out of bed. FEEDING :└-┘/2

0 feeding without help

  1. need help cutting meat or buttering bread
  2. needs total help or requires parenteral feeding. TOTAL : └-┴-┘/10 If the patient has a result of 2 at bathing and or dressing he can't be randomized at T6M
at 6 months
the ADL scale
Time Frame: at 12 months

ADL DE KATZ BATHING :└-┘/2 0 bathes self completely

  1. needs help in bathing only one part of the body
  2. needs help with bathing more than one part of the body or not bathed DRESSING :└-┘ /2

0 gets clothes and gets completely dressed without assistance

1 gets clothes and gets dressed without assistance, except for assistance in tying shoes 2 receives assistance in getting clothes or in getting dressed, or stays partly or completely undressed TOILETING :└-┘/2 0 toileting without assistance (may use cane, walker, or wheelchair)

1 receives assistance 2 doesn't go to room termed " toilet ". TRANSFER:└-┘/2 0 transfer without assistance (may be using cane or walker)

  1. transfer with assistance
  2. doesn't get out of bed. FEEDING :└-┘/2

0 feeding without help

  1. need help cutting meat or buttering bread
  2. needs total help or requires parenteral feeding. TOTAL : └-┴-┘/10
at 12 months
the ADL scale
Time Frame: at 18 months

ADL DE KATZ BATHING :└-┘/2 0 bathes self completely

  1. needs help in bathing only one part of the body
  2. needs help with bathing more than one part of the body or not bathed DRESSING :└-┘ /2

0 gets clothes and gets completely dressed without assistance

1 gets clothes and gets dressed without assistance, except for assistance in tying shoes 2 receives assistance in getting clothes or in getting dressed, or stays partly or completely undressed TOILETING :└-┘/2 0 toileting without assistance (may use cane, walker, or wheelchair)

1 receives assistance 2 doesn't go to room termed " toilet ". TRANSFER:└-┘/2 0 transfer without assistance (may be using cane or walker)

  1. transfer with assistance
  2. doesn't get out of bed. FEEDING :└-┘/2

0 feeding without help

  1. need help cutting meat or buttering bread
  2. needs total help or requires parenteral feeding. TOTAL : └-┴-┘/10
at 18 months
the ADL scale
Time Frame: at 24 months

ADL DE KATZ BATHING :└-┘/2 0 bathes self completely

  1. needs help in bathing only one part of the body
  2. needs help with bathing more than one part of the body or not bathed DRESSING :└-┘ /2

0 gets clothes and gets completely dressed without assistance

1 gets clothes and gets dressed without assistance, except for assistance in tying shoes 2 receives assistance in getting clothes or in getting dressed, or stays partly or completely undressed TOILETING :└-┘/2 0 toileting without assistance (may use cane, walker, or wheelchair)

1 receives assistance 2 doesn't go to room termed " toilet ". TRANSFER:└-┘/2 0 transfer without assistance (may be using cane or walker)

  1. transfer with assistance
  2. doesn't get out of bed. FEEDING :└-┘/2

0 feeding without help

  1. need help cutting meat or buttering bread
  2. needs total help or requires parenteral feeding. TOTAL : └-┴-┘/10
at 24 months
the ADL scale
Time Frame: at 30 months

ADL DE KATZ BATHING :└-┘/2 0 bathes self completely

  1. needs help in bathing only one part of the body
  2. needs help with bathing more than one part of the body or not bathed DRESSING :└-┘ /2

0 gets clothes and gets completely dressed without assistance

1 gets clothes and gets dressed without assistance, except for assistance in tying shoes 2 receives assistance in getting clothes or in getting dressed, or stays partly or completely undressed TOILETING :└-┘/2 0 toileting without assistance (may use cane, walker, or wheelchair)

1 receives assistance 2 doesn't go to room termed " toilet ". TRANSFER:└-┘/2 0 transfer without assistance (may be using cane or walker)

  1. transfer with assistance
  2. doesn't get out of bed. FEEDING :└-┘/2

0 feeding without help

  1. need help cutting meat or buttering bread
  2. needs total help or requires parenteral feeding. TOTAL : └-┴-┘/10
at 30 months
the MMSE score
Time Frame: at inclusion
The MMSE score will be assessed by the clinician, the psychologist or the speech therapist according to the habits of the center, using the French version of the MMSE (GRECO version)
at inclusion
the MMSE score
Time Frame: at 6 months
The MMSE score will be assessed by the clinician, the psychologist or the speech therapist according to the habits of the center, using the French version of the MMSE (GRECO version)
at 6 months
the MMSE score
Time Frame: at 12 months
The MMSE score will be assessed by the clinician, the psychologist or the speech therapist according to the habits of the center, using the French version of the MMSE (GRECO version)
at 12 months
the MMSE score
Time Frame: at 18 months
The MMSE score will be assessed by the clinician, the psychologist or the speech therapist according to the habits of the center, using the French version of the MMSE (GRECO version)
at 18 months
the MMSE score
Time Frame: at 24 months
The MMSE score will be assessed by the clinician, the psychologist or the speech therapist according to the habits of the center, using the French version of the MMSE (GRECO version)
at 24 months
the MMSE score
Time Frame: at 30 months
The MMSE score will be assessed by the clinician, the psychologist or the speech therapist according to the habits of the center, using the French version of the MMSE (GRECO version)
at 30 months
the number of hospitalizations
Time Frame: at inclusion
The number of hospitalizations will be assessed using standardized questionnaire, with date (month/year) and duration of hospitalization;
at inclusion
the number of hospitalizations
Time Frame: at 6 months
The number of hospitalizations will be assessed using standardized questionnaire, with date (month/year) and duration of hospitalization;
at 6 months
the number of hospitalizations
Time Frame: at 12 months
The number of hospitalizations will be assessed using standardized questionnaire, with date (month/year) and duration of hospitalization;
at 12 months
the number of hospitalizations
Time Frame: at 18 months
The number of hospitalizations will be assessed using standardized questionnaire, with date (month/year) and duration of hospitalization;
at 18 months
the number of hospitalizations
Time Frame: at 24 months
The number of hospitalizations will be assessed using standardized questionnaire, with date (month/year) and duration of hospitalization;
at 24 months
the number of hospitalizations
Time Frame: at 30 months
The number of hospitalizations will be assessed using standardized questionnaire, with date (month/year) and duration of hospitalization;
at 30 months
Pharmacologie treatments consumed by the patient
Time Frame: at inclusion
All the pharmacologie treatments consumed by the patient will be assessed, allowing to assess psychotropic drug consumption.
at inclusion
Pharmacologie treatments consumed by the patient
Time Frame: at 6 months
All the pharmacologie treatments consumed by the patient will be assessed, allowing to assess psychotropic drug consumption.
at 6 months
Pharmacologie treatments consumed by the patient
Time Frame: at 12 months
All the pharmacologie treatments consumed by the patient will be assessed, allowing to assess psychotropic drug consumption.
at 12 months
Pharmacologie treatments consumed by the patient
Time Frame: at 18 months
All the pharmacologie treatments consumed by the patient will be assessed, allowing to assess psychotropic drug consumption.
at 18 months
Pharmacologie treatments consumed by the patient
Time Frame: at 24 months
All the pharmacologie treatments consumed by the patient will be assessed, allowing to assess psychotropic drug consumption.
at 24 months
Pharmacologie treatments consumed by the patient
Time Frame: at 30 months
All the pharmacologie treatments consumed by the patient will be assessed, allowing to assess psychotropic drug consumption.
at 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

April 27, 2027

Study Completion (Estimated)

September 15, 2027

Study Registration Dates

First Submitted

February 9, 2018

First Submitted That Met QC Criteria

February 26, 2018

First Posted (Actual)

March 6, 2018

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2016/27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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