Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03724448 |
| Other study ID # |
PHYTéS |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
June 30, 2018 |
| Est. completion date |
September 1, 2018 |
Study information
| Verified date |
March 2023 |
| Source |
Hôpital Universitaire Sahloul |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Psycho-traumatic disorders are a disabling condition whose epidemiological data vary
according to the country but also the populations studied and the measuring instruments used.
The estimated prevalence of posttraumatic stress disorder (PTSD) appeared to be increasing in
recent years, and this appears to be due, among other things, to the improvement of the
standardized evaluation procedure. The survey "Mental Health in General Population",
conducted in metropolitan France between 1999 and 2003 on more than 36,000 people estimated
its instantaneous prevalence (last month) of a full PTSD was 0.7% in the SMPG overall sample,
with almost equal frequency between men (45%) and women (55%). This figure is close to that
reported in a European population for the ESEMeD study. A very significant psychiatric
comorbidity was found in subjects with PTSD, particularly with mood disorders, other anxiety
disorders and addictive behaviors. The link with the suicidal risk was clearly established,
which is the gravity of this pathology.
The most important publications are made by American teams who have identified and evaluated
the treatment of this pathology among veterans of the various wars led by the country.
Description:
Psycho-traumatic disorders are a disabling condition whose epidemiological data vary
according to the country but also the populations studied and the measuring instruments used.
The estimated prevalence of posttraumatic stress disorder (PTSD) appeared to be increasing in
recent years, and this appears to be due, among other things, to the improvement of the
standardized evaluation procedure. The survey "Mental Health in General Population",
conducted in metropolitan France between 1999 and 2003 on more than 36,000 people estimated
its instantaneous prevalence (last month) of a full PTSD was 0.7% in the SMPG overall sample,
with almost equal frequency between men (45%) and women (55%). This figure is close to that
reported in a European population for the ESEMeD study. A very significant psychiatric
comorbidity was found in subjects with PTSD, particularly with mood disorders, other anxiety
disorders and addictive behaviors. The link with the suicidal risk was clearly established,
which is the gravity of this pathology.
The most important publications are made by American teams who have identified and evaluated
the treatment of this pathology among veterans of the various wars led by the country.
Barrois defines traumatic neurosis as "a group of psychological disorders that arise after a
longer or shorter latency, following a very intense emotional shock".
Post-traumatic stress disorder is defined by the ICD-10 classification as a "delayed or
prolonged" response to a stressful situation or event (short or long-term) that would provoke
distress symptoms in anyone .
According to the American classification of the DSM-V, the diagnosis of PTSD is strictly
established according to different criteria. Exposure to a traumatic event ("the person has
been exposed, witnessed or confronted with an event or events that have involved death or
death, or serious injury or threat to their physical integrity or 'others'), and reacting to
it with a feeling of intense fear, helplessness or horror (criterion A). The event is
constantly relived, manifested by at least one symptom of the repetition syndrome (criterion
B) that can be repetitive and invasive memories of the event (including images, thoughts,
perceptions), repetitive and painful dreams of the event, the impression or sudden acts "as
if" the traumatic event recurred, an intense psychological distress when exposed to internal
or external stimuli resembling an aspect of the trauma, a physiological reactivity during
exposure to internal or external stimuli resembling or symbolizing an aspect of the trauma.
Criterion C requires persistent avoidance of stimuli associated with trauma and blunting of
general responsiveness (not present before trauma).
Criterion D refers to the impairment of cognition and mood associated with one or more
traumatic events manifested by at least two symptoms, including dissociative amnesia,
persistent and exaggerated negative self-perceptions of others, and world, a clear reduction
of interest in important activities, a feeling of detachment and a persistent inability to
feel positive emotions. There are also symptoms of neurovegetative activation, with at least
two symptoms (criterion E) among sleep difficulties, irritability or anger, difficulty
concentrating, hyper vigilance, startled reactions exaggerated. Criterion F concerns the
duration of symptoms B, C and D which must exceed one month. The problem results in
clinically significant distress or dysfunction at the social, occupational or other important
operational level (criterion G). Criterion H eliminates that these symptoms are not due to
the consumption of a substance (drug or alcohol) or another condition.
Despite this awareness of the functional impact of these psycho traumatic disorders, this
pathology has remained under-identified both by health professionals and the general public
and subsequently insufficiently treated, particularly in Tunisia. Several therapeutic
protocols are proposed. The share of antidepressant treatments (yet first-line treatment in
all international guidelines) is only 30% and the remaining 70% includes anxiolytics,
hypnotics and herbal medicine. Several meta-analyzes have evaluated the efficacy of different
families of antidepressants, but scientific research remains very poor in the field of herbal
medicine.
