Frontlight ResearchEarly access
CompletedNo phase
Effect of Baclofen to Prevent Post-Traumatic Stress Disorder
Key facts
- Who runs it
- Nantes University Hospital
- Where
- France13 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 94 people enrolled
- Started
- 3 Sept 2023
- Ended
- 28 Feb 2024
- Type of study
- Observational, 2 groups
- Treatments tested
- Baclofen
- Placebo
- Record updated
- 17 June 2024
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- All incident patients included in the BACLOREA trial. As a reminder, the criteria were :
- Patients under guardianship/guardianship at the time of initial inclusion or since the end of the Balorea study will not be contacted and therefore will not be analyzed in this research.Non-cerebrodamaged patients admitted to intensive care regardless of the causal pathology with:
- Consumption of alcohol qualified as "at risk" (For men aged 18 to 64: Consumption ≥ 14 drinks/week in the month preceding hospitalization; For men > 65 and women: Consumption > 7 drinks /week in the month preceding hospitalization)
- AND Intubated, ventilated with an expected duration of mechanical ventilation of at least 48 hours
- AND Aged 18 to 80
Who cannot take part
- Patients who died during the study or within 5 years of inclusion will not be included. Also, patients who withdrew their consent after inclusion in the Balorea study will not be included. Similarly, patients refusing to answer telephone questionnaires will not be included. Known deceased patients will not be contacted
- Patients under guardianship/guardianship at the time of initial inclusion or since the end of the Balorea study will not be contacted and therefore will not be analyzed in this research
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Considering the results of the Baclorea study (10% reduction in episodes of agitation in intensive care in the Baclofen group), the investigators would like to know whether this reduction in agitation also results in a reduction in the incidence of the syndrome of long-term post-traumatic stress (5 years later).
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The investigators wish to contact by telephone, blinded from the randomization group as defined in the framework of the Balorea project, by telephone contact, the patients who had been included in the Balorea study between June 2016 and February 2019.
The 2 groups in the trial
- Experimental : BACLOFEN
Patient will receive baclofen caps
Treatment: Baclofen
- Placebo Comparator : PLACEBO
Patient will receive placebo caps (lactose)
Treatment: Placebo
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effect of Baclofen to Prevent Post-Traumatic Stress Disorder: 5 Years Follow-up of the BACLOREA Randomized Trial
- Publications
- Record updated
- 17 June 2024