DepressionAQVARNCT02762409
Improve the Quality of Life After a Hospitalization in Critical Care
An observational study of Depression and Depression Symptoms, run by Centre Hospitalier of Chartres at 12 sites in France.
Trial summary
Demonstrate that the IPREA3 program (Study: Impact of Multicomponent Intervention to Reduce Perceived Discomforts of the patients in intensive care) reducing discomforts perceived by the patients of intensive care, implemented at the level of the whole intensive care unit, reduce the incidence of the depressive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Depression Symptoms
- What is being tested?
- experimental
- How many people
- 1,006 participants
- Where
- 12 sitesFrance
- Study dates
- 1 Oct 2015to 31 Dec 2016
- How long will I take part?
- 1 Year
- 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: All the patients included in the study AQVAR will be patients included before in the study IPREA3 for whom the IPREA3 questionnary of measure of the discomforts collected by the patients will be informed (available score for each of the items establishing the questionnaire IPREA3). The inclusion of the patients in the study AQVAR will be made the day of the intensive care exit.
Who may be able to join
- The same criteria of the IPREA3 study
- Taken out alive of intensive care
- Hospitalization in intensive care extending at least over three calendar days.
Who cannot join
- Deaths in intensive care
- Age 18-year-old inferior
- Under guardianship patient
- Incompatible situation with the administration of the IPREA questionnaire at the exit of intensive care: presence of neuropsychic disorders, language barrier, transfer under mechanical ventilation, taken out of intensive care in urgency
- Patient refused to participate in the study IPREA3
- Patient refused to participate in the study AQVAR
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
C.H. de Chartres
Chartres, 28018
CHU Beaujon APHP
Clichy, 92110
CH Douai
Douai, 59507
CH La Rochelle
La Rochelle, 17022
CH Le Puy en Velay
Le Puy-en-Velay, 43000
CH Lens
Lens, 62300
CHU Edouard Herriot
Lyon, 69003
CHU Saint Louis APHP
Paris, 75010
CHU Cochin APHP
Paris, 75014
CHU NHC
Strasbourg, 67000
CHU Hautepierre
Strasbourg, 67100
CH Troyes
Troyes, 10000
About this study
Official title: Improve the Quality of Life After a Hospitalization in Critical Care Thanks to a Program of Prevention of Discomforts Perceived by the Patients of Critical Care Base on Targeted Measures
Demonstrate that the IPREA3 program (Study: Impact of Multicomponent Intervention to Reduce Perceived Discomforts of the patients in intensive care) reducing discomforts perceived by the patients of intensive care, implemented at the level of the whole intensive care unit, reduce the incidence of the depressive symptoms one year after intensive care exit.
Read the detailed description
AQVAR is a study of type not exposed presentations, study ancillary of controlled study, multicentric with randomization to cluster, the study IPREA3, for which a financing was already obtained within the framework of the Hospital National Clinical Program of Research on 2012, current study, the inclusions of which began on October 1st, 2014 after the obtaining of all the necessary authorizations. To date, more than 4300 patients were included in the study IPREA3 within 34 departments or intensive care units participating on approval. All the patients included in the study AQVAR will be patients included before in the study IPREA3 and which a complete questionnaire IPREA3 of measure of the discomforts collected by all the patients of intensive care will be available.
The AQVAR study leans on the original current research IPREA3 which consists of the evaluation of a program with multiple components of reduction of the discomforts collected by the patients of including in intensive care:
- The preliminary identification of a binomial doctor-nurse of local coordinating experts of the program IPREA3
- A systematic measure of the discomforts collected by means of the questionnaire IPREA administered the day of the exit.
- An immediate return of the scores of discomfort in every nursing administering the questionnaire IPREA
- The implementation of measures targeted by reduction of the discomforts, based on the analysis of the results appropriate to the intensive care unit.
The innovative character is also brought by the research for the association between conditions of hospitalization in intensive care according to the perception of the patient and very remote quality of life of the hospitalization in intensive care , as well as by the evaluation of a method of primary prevention of the psychiatric morbidity post-intensive care.
The individual profits waited for the patient hospitalized in an intensive care unit having implemented the program of reduction of the discomforts IPREA3 are the improvement of its conditions of hospitalization during its whole stay in intensive care, such as the patient perceives them at the exit of intensive care, then remote, a reduction of the risk of arisen a state of post-traumatic stress, anxious and/or depressive symptoms, and cognitive dysfunctions. This reduction of the psychiatric morbidity should lead to an improvement of its quality of life bound to the health, but also to the recourse to the consultations in an emergency department or to the new hospitalizations.
The expected main collective profits are a better description of the post-traumatic states of stress consecutive to a hospitalization in intensive care, as well as an understanding of mechanisms and risk factors of arisen this psychiatric morbidity.
If the study AQVAR allows to show the tested hypothesis, it will be an additional, decisive argument, to implement in all the intensive care units a program with multiple components of type IPREA3 of reduction of the received discomforts, requiring the commitment of all the healthcare professionals, whose feasibility is in the course of demonstration, and which must be integrated into the projects of department and establishment.
The additional expected collective profits concern two other populations:
- The close relations of the patients hospitalized in intensive care, according to the hypothesis of an interaction between the quality of life of the patients after the intensive care and that of their susceptible close relations they too to develop a state of post-traumatic stress after the hospitalization in intensive care.
- The health workers practicing in intensive care, among which the job satisfaction, and possibly the level risks of professional exhaustion, should be improved by the membership in a department applying the program, federative, of reduction of the discomforts in intensive care, applied by the whole team specialized in intensive care.
- Conditions
- Depression, Depression Symptoms
- Being tested
- experimental, control
- Keywords
- critical care, reduction of depression syndrome, anxiety, quality of life, post traumatic stress, discomforts
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimentalOther
corresponding to surviving individuals of a hospitalization in intensive care in a department having set up the program of reduction of the discomforts collected by the patients of intensive care during a minimal period of 5 months. The program is so defined as factor of exposure and supposed protector of development of anxio-depressive disorders.These patients will have been included in the study IPREA3 in 17 centers of the interventional group of the study IPREA3 during the months of April, 2015 and October, 2015
controlOther
The patients "not exposed" in the supposed factor protector of development of anxio-depressive disorders will be constituted by the patients estimated in the study IPREA3 corresponding to surviving individuals of a hospitalization in intensive care in a department having never operated the program of reduction of the discomforts collected by the patients of intensive care. These patients will have been included in the study IPREA3 in 17 centers of the group control some study IPREA3 during October 2014 and April, 2015
| Study group | Role | What they receive |
|---|---|---|
| patients exposed | Patients exposed will be estimated in the study IPREA3 corresponding to surviving individuals of a hospitalization in intensive care in a department having set up the program of reduction of the discomforts collected by the patients of intensive care during a minimal period of 5 months. The program is so defined as factor of exposure and supposed protector of development of anxio-depressive disorders.These patients will have been included in the study IPREA3 in 17 centers of the interventional group of the study IPREA3 during the months of April, 2015 and October, 2015, and in 17 centers of the group control some study IPREA3 during October 2015 Receives: Other: experimental | |
| patients non exposed | The patients "not exposed" in the supposed factor protector of development of anxio-depressive disorders will be constituted by the patients estimated in the study IPREA3 corresponding to surviving individuals of a hospitalization in intensive care in a department having never operated the program of reduction of the discomforts collected by the patients of intensive care. These patients will have been included in the study IPREA3 in 17 centers of the group control some study IPREA3 during October 2014 and April, 2015 and in 17 centers of the interventional group during October 2014 Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve the reduction of depressive symptoms
A score 8 (maximal score of 21) allows to hold the presence of clinically significant depressive symptoms.
Measured: up to 52 weeks of the hospitalization
Secondary outcomes (5)
Score of the sub-scale A of the questionnaire HAD-S ( Hospital and Anxiety Depression Scale)
Allowing to estimate the presence of anxious symptoms. Score of the sub-scale A of the questionnaire HAD-S one year after the exit of intensive care allowing to estimate the presence of anxious symptoms. A score 8 (maximal score of 21) allows to hold the presence of clinically significant anxious symptoms.
The scale HAD contains 14 highly-rated items from 0 to 3. Seven questions relate to the anxiety ( total A) and seven others in the depressive dimension (total D), so allowing the obtaining of two scores, the maximal note of wich for each of them is 21.
Measured: up to 52 weeks of the hospitalization
Score IES-R ( impact of Events Scale-Revised)
Allowing to detect a risk of state of post traumatic stress.
Measured: up to 52 weeks of the hospitalization
Questionnaire EQ-5D
Indicators of quality of life estimated by questionnaires EQ-5D
Measured: up to 52 weeks of the hospitalization
Describe quality of life
Return home, taken by a professional activity, an existence of a psychiatric or psychological follow up, and a regular consumption of psychotropics
Measured: up to 52 weeks of the hospitalization
Duration of hospitalization
Informations are in the medical bases statistic of each hospital
Measured: Consecutive to the hospitalization in intensive care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study start1 Oct 2015
- Primary completion31 Oct 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- 1,006 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier of Chartres
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre KALFON, PhD, Principal investigator, CH CHARTRES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762409
- Sponsor's protocol ID
- PREPS-15-15-0183
- Acronym
- AQVAR
- Status last verified
- Aug 2016
- First submitted
- 18 Apr 2016
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Griffiths J, Fortune G, Barber V, Young JD. The prevalence of post traumatic stress disorder in survivors of ICU treatment: a systematic review. Intensive Care Med. 2007 Sep;33(9):1506-18. doi: 10.1007/s00134-007-0730-z. Epub 2007 Jun 9.
PubMed 17558490Pandharipande PP, Girard TD, Ely EW. Long-term cognitive impairment after critical illness. N Engl J Med. 2014 Jan 9;370(2):185-6. doi: 10.1056/NEJMc1313886. No abstract available.
PubMed 24401069Davydow DS, Hough CL, Zatzick D, Katon WJ. Psychiatric symptoms and acute care service utilization over the course of the year following medical-surgical ICU admission: a longitudinal investigation*. Crit Care Med. 2014 Dec;42(12):2473-81. doi: 10.1097/CCM.0000000000000527.
PubMed 25083985Davydow DS, Zatzick D, Hough CL, Katon WJ. A longitudinal investigation of posttraumatic stress and depressive symptoms over the course of the year following medical-surgical intensive care unit admission. Gen Hosp Psychiatry. 2013 May-Jun;35(3):226-32. doi: 10.1016/j.genhosppsych.2012.12.005. Epub 2013 Jan 28.
PubMed 23369507Kalfon P, Mimoz O, Auquier P, Loundou A, Gauzit R, Lepape A, Laurens J, Garrigues B, Pottecher T, Malledant Y. Development and validation of a questionnaire for quantitative assessment of perceived discomforts in critically ill patients. Intensive Care Med. 2010 Oct;36(10):1751-1758. doi: 10.1007/s00134-010-1902-9. Epub 2010 May 26.
PubMed 20502874Kalfon P, Alessandrini M, Boucekine M, Renoult S, Geantot MA, Deparis-Dusautois S, Berric A, Collange O, Floccard B, Mimoz O, Julien A, Robert R, Audibert J, Renault A, Follin A, Thevenin D, Revel N, Venot M, Patrigeon RG, Signouret T, Fromentin M, Sharshar T, Vigne C, Pottecher J, Levrat Q, Sossou A, Garrouste-Orgeas M, Quenot JP, Boulle C, Azoulay E, Baumstarck K, Auquier P; IPREA-AQVAR Study Group. Tailored multicomponent program for discomfort reduction in critically ill patients may decrease post-traumatic stress disorder in general ICU survivors at 1 year. Intensive Care Med. 2019 Feb;45(2):223-235. doi: 10.1007/s00134-018-05511-y. Epub 2019 Jan 30.
PubMed 30701294
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improve the Quality of Life After a Hospitalization in Critical Care Thanks to a Program of Prevention of Discomforts Perceived by the Patients of Critical Care Base on Targeted Measures
- ClinicalTrials.gov ID
- NCT02762409
- Acronym / sponsor ID
- AQVAR / PREPS-15-15-0183
- Conditions
- Depression, Depression Symptoms
- Keywords
- critical care, reduction of depression syndrome, anxiety, quality of life, post traumatic stress, discomforts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,006 participants (actual)
- Lead sponsor
- Centre Hospitalier of ChartresUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 5 May 2016 (estimated)
- 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.
Demonstrate that the IPREA3 program (Study: Impact of Multicomponent Intervention to Reduce Perceived Discomforts of the patients in intensive care) reducing discomforts perceived by the patients of intensive care, implemented at the level of the whole intensive care unit, reduce the incidence of the depressive symptoms one year after intensive care exit.
Detailed description
AQVAR is a study of type not exposed presentations, study ancillary of controlled study, multicentric with randomization to cluster, the study IPREA3, for which a financing was already obtained within the framework of the Hospital National Clinical Program of Research on 2012, current study, the inclusions of which began on October 1st, 2014 after the obtaining of all the necessary authorizations. To date, more than 4300 patients were included in the study IPREA3 within 34 departments or intensive care units participating on approval. All the patients included in the study AQVAR will be patients included before in the study IPREA3 and which a complete questionnaire IPREA3 of measure of the discomforts collected by all the patients of intensive care will be available.
The AQVAR study leans on the original current research IPREA3 which consists of the evaluation of a program with multiple components of reduction of the discomforts collected by the patients of including in intensive care:
- The preliminary identification of a binomial doctor-nurse of local coordinating experts of the program IPREA3
- A systematic measure of the discomforts collected by means of the questionnaire IPREA administered the day of the exit.
- An immediate return of the scores of discomfort in every nursing administering the questionnaire IPREA
- The implementation of measures targeted by reduction of the discomforts, based on the analysis of the results appropriate to the intensive care unit.
The innovative character is also brought by the research for the association between conditions of hospitalization in intensive care according to the perception of the patient and very remote quality of life of the hospitalization in intensive care , as well as by the evaluation of a method of primary prevention of the psychiatric morbidity post-intensive care.
The individual profits waited for the patient hospitalized in an intensive care unit having implemented the program of reduction of the discomforts IPREA3 are the improvement of its conditions of hospitalization during its whole stay in intensive care, such as the patient perceives them at the exit of intensive care, then remote, a reduction of the risk of arisen a state of post-traumatic stress, anxious and/or depressive symptoms, and cognitive dysfunctions. This reduction of the psychiatric morbidity should lead to an improvement of its quality of life bound to the health, but also to the recourse to the consultations in an emergency department or to the new hospitalizations.
The expected main collective profits are a better description of the post-traumatic states of stress consecutive to a hospitalization in intensive care, as well as an understanding of mechanisms and risk factors of arisen this psychiatric morbidity.
If the study AQVAR allows to show the tested hypothesis, it will be an additional, decisive argument, to implement in all the intensive care units a program with multiple components of type IPREA3 of reduction of the received discomforts, requiring the commitment of all the healthcare professionals, whose feasibility is in the course of demonstration, and which must be integrated into the projects of department and establishment.
The additional expected collective profits concern two other populations:
- The close relations of the patients hospitalized in intensive care, according to the hypothesis of an interaction between the quality of life of the patients after the intensive care and that of their susceptible close relations they too to develop a state of post-traumatic stress after the hospitalization in intensive care.
- The health workers practicing in intensive care, among which the job satisfaction, and possibly the level risks of professional exhaustion, should be improved by the membership in a department applying the program, federative, of reduction of the discomforts in intensive care, applied by the whole team specialized in intensive care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients exposed | – | Other: experimentalPatients exposed will be estimated in the study IPREA3 corresponding to surviving individuals of a hospitalization in intensive care in a department having set up the program of reduction of the discomforts collected by the patients of intensive care during a minimal period of 5 months. The program is so defined as factor of exposure and supposed protector of development of anxio-depressive disorders.These patients will have been included in the study IPREA3 in 17 centers of the interventional group of the study IPREA3 during the months of April, 2015 and October, 2015, and in 17 centers of the group control some study IPREA3 during October 2015 |
| patients non exposed | – | Other: controlThe patients "not exposed" in the supposed factor protector of development of anxio-depressive disorders will be constituted by the patients estimated in the study IPREA3 corresponding to surviving individuals of a hospitalization in intensive care in a department having never operated the program of reduction of the discomforts collected by the patients of intensive care. These patients will have been included in the study IPREA3 in 17 centers of the group control some study IPREA3 during October 2014 and April, 2015 and in 17 centers of the interventional group during October 2014 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients included in the study AQVAR will be patients included before in the study IPREA3 for whom the IPREA3 questionnary of measure of the discomforts collected by the patients will be informed (available score for each of the items establishing the questionnaire IPREA3). The inclusion of the patients in the study AQVAR will be made the day of the intensive care exit.
Key inclusion criteria (3 listed)
- The same criteria of the IPREA3 study
- Taken out alive of intensive care
- Hospitalization in intensive care extending at least over three calendar days.
Key exclusion criteria (6 listed)
- Deaths in intensive care
- Age 18-year-old inferior
- Under guardianship patient
- Incompatible situation with the administration of the IPREA questionnaire at the exit of intensive care: presence of neuropsychic disorders, language barrier, transfer under mechanical ventilation, taken out of intensive care in urgency
- Patient refused to participate in the study IPREA3
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 |
|---|---|---|
| experimentalcorresponding to surviving individuals of a hospitalization in intensive care in a department having set up the program of reduction of the discomforts collected by the patients of intensive care during a minimal period of 5 months. The program is so defined as factor of exposure and supposed protector of development of anxio-depressive disorders.These patients will have been included in the study IPREA3 in 17 centers of the interventional group of the study IPREA3 during the months of April, 2015 and October, 2015 | Other | patients exposed |
| controlThe patients "not exposed" in the supposed factor protector of development of anxio-depressive disorders will be constituted by the patients estimated in the study IPREA3 corresponding to surviving individuals of a hospitalization in intensive care in a department having never operated the program of reduction of the discomforts collected by the patients of intensive care. These patients will have been included in the study IPREA3 in 17 centers of the group control some study IPREA3 during October 2014 and April, 2015 | Other | patients non exposed |
Primary outcome
Improve the reduction of depressive symptoms
Time frame: up to 52 weeks of the hospitalization
A score 8 (maximal score of 21) allows to hold the presence of clinically significant depressive symptoms.
5 secondary outcomes
Score of the sub-scale A of the questionnaire HAD-S ( Hospital and Anxiety Depression Scale)
Time frame: up to 52 weeks of the hospitalization
Score IES-R ( impact of Events Scale-Revised)
Time frame: up to 52 weeks of the hospitalization
Questionnaire EQ-5D
Time frame: up to 52 weeks of the hospitalization
Describe quality of life
Time frame: up to 52 weeks of the hospitalization
Duration of hospitalization
Time frame: Consecutive to the hospitalization in intensive care
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 24 Jul 2017.
- Results publication: PubMed 17558490Griffiths J, Fortune G, Barber V, Young JD. The prevalence of post traumatic stress disorder in survivors of ICU treatment: a systematic review. Intensive Care Med. 2007 Sep;33(9):1506-18. doi: 10.1007/s00134-007-0730-z. Epub 2007 Jun 9.
- Results publication: PubMed 24401069Pandharipande PP, Girard TD, Ely EW. Long-term cognitive impairment after critical illness. N Engl J Med. 2014 Jan 9;370(2):185-6. doi: 10.1056/NEJMc1313886. No abstract available.
- Results publication: PubMed 25083985Davydow DS, Hough CL, Zatzick D, Katon WJ. Psychiatric symptoms and acute care service utilization over the course of the year following medical-surgical ICU admission: a longitudinal investigation*. Crit Care Med. 2014 Dec;42(12):2473-81. doi: 10.1097/CCM.0000000000000527.
- Results publication: PubMed 23369507Davydow DS, Zatzick D, Hough CL, Katon WJ. A longitudinal investigation of posttraumatic stress and depressive symptoms over the course of the year following medical-surgical intensive care unit admission. Gen Hosp Psychiatry. 2013 May-Jun;35(3):226-32. doi: 10.1016/j.genhosppsych.2012.12.005. Epub 2013 Jan 28.
- Results publication: PubMed 20502874Kalfon P, Mimoz O, Auquier P, Loundou A, Gauzit R, Lepape A, Laurens J, Garrigues B, Pottecher T, Malledant Y. Development and validation of a questionnaire for quantitative assessment of perceived discomforts in critically ill patients. Intensive Care Med. 2010 Oct;36(10):1751-1758. doi: 10.1007/s00134-010-1902-9. Epub 2010 May 26.
- Derived from this study: PubMed 30701294Kalfon P, Alessandrini M, Boucekine M, Renoult S, Geantot MA, Deparis-Dusautois S, Berric A, Collange O, Floccard B, Mimoz O, Julien A, Robert R, Audibert J, Renault A, Follin A, Thevenin D, Revel N, Venot M, Patrigeon RG, Signouret T, Fromentin M, Sharshar T, Vigne C, Pottecher J, Levrat Q, Sossou A, Garrouste-Orgeas M, Quenot JP, Boulle C, Azoulay E, Baumstarck K, Auquier P; IPREA-AQVAR Study Group. Tailored multicomponent program for discomfort reduction in critically ill patients may decrease post-traumatic stress disorder in general ICU survivors at 1 year. Intensive Care Med. 2019 Feb;45(2):223-235. doi: 10.1007/s00134-018-05511-y. Epub 2019 Jan 30.
- 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.
Pierre KALFON, PhD principal investigator
CH CHARTRES
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Depression Symptoms, run by Centre Hospitalier of Chartres at 12 sites 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 6 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 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Improve the reduction of depressive symptoms (time frame: up to 52 weeks of the hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02762409, which also lists 6 linked publications.
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 24 Jul 2017.