Aún no reclutaNCT07927192Registro de ClinicalTrials.gov

Medical Nitrous Oxide Combined With Personalized Traumatic Script Exposure for the Treatment of Post-Traumatic Stress Disorder

PTSD - Post Traumatic Stress Disorder

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LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: De intervención
Fase: Fase 3
Rango de edad: 18 años - 65 años
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 96 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

The goal of this double-blind randomized controlled superiority clinical trial is to evaluate whether medical nitrous oxide/oxygen premix (MEOPA), combined with exposure to a personalized traumatic script, can improve symptoms of posttraumatic stress disorder (PTSD) in adults with treatment-resistant PTSD related to interpersonal violence.

The main questions it aims to answer are:

1. Does MEOPA combined with traumatic script exposure reduce PTSD symptom severity, as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), compared with medical air combined with traumatic script exposure?
2. Does MEOPA improve associated symptoms and functioning, including depression, anxiety, dissociation, and functional impairment, while maintaining an acceptable safety profile?

Researchers will compare participants receiving MEOPA plus traumatic script exposure with participants receiving medical air plus traumatic script exposure to determine whether MEOPA enhances the therapeutic effects of trauma-focused re-exposure.

Participants will:

Attend a screening and baseline assessment visit.
Complete clinician-administered and self-reported questionnaires assessing PTSD symptoms, depression, anxiety, dissociation, suicidality, and functional impairment.
Write a personalized traumatic script based on their traumatic experience.
Be randomized to receive either MEOPA or medical air.
Undergo four weekly treatment sessions consisting of inhalation of the assigned gas combined with exposure to their personalized traumatic script.
Attend follow-up visits at 1, 3, 6, and 9 months after treatment for evaluation of efficacy and safety outcomes.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

Age 18 - 65
Patient with PTSD who has failed to respond to at least one therapeutic approach, psychotherapy or treatment with an SSRI
Nature of the traumatic event: interpersonal violence, including sexual, physical and psychological abuse
PTSD as defined by the DSM-5, with symptoms present for more than 6 months
CAPS-5 score ≥35
Participant who can receive MEOPA or medical oxygen through a face mask
French-speaking
Social security affiliation
Signed consent
A suitable method of contraception for women of childbearing age

Exclusion Criteria:

Current substance use disorders or history of substance use disorder.
Psychotic, bipolar, dissociative identity, or eating disorders.

\* suicidal risque with C-SSR score ≥4
* Pregnancy and/or breastfeeding.
* Patients subject to legal guardianship and/or other circumstances rendering the patient unable to understand the nature, purpose or consequences of the study.
* Contraindication to the use of MEOPA and any condition where air is trapped inside the body and where its expansion could be dangerous: pneumothorax, emphysema, intestinal obstruction, intracranial hypertension, known and untreated deficiency of vitamin B12 or B9 (based on a test result less than 1 month old), Patients requiring ventilation with pure oxygen; any impairment of consciousness preventing patient cooperation; head injury; Gas embolism; Diving accident; Abdominal gas distension; Patient who has recently received an ophthalmic gas (SF6, C3F8, C2F6) used in eye surgery (as long as a gas bubble persists inside the eye and for a minimum period of 3 months), neurological abnormalities of recent or non-recent onset.
* Sub-physiological plasma concentration of vitamin B12 or B9 (below the lower limit of the laboratory's reference range).
* Supraphysiological plasma concentration of homocysteine (above the upper limit of the laboratory's reference range).

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Enmascaramiento triple

MEOPA + Personalized Traumatic Script Exposure

Participants receive inhaled medical nitrous oxide/oxygen premix (MEOPA) combined with exposure to a personalized traumatic script. Four treatment sessions are administered at weekly intervals. During each session, participants undergo 45 minutes of inhalation following the reading of their personalized traumatic script.

Drug: MEOPA (Nitrous Oxide/Oxygen Premix) · Behavioral: Personalized Traumatic Script Exposure

Medical Air + Personalized Traumatic Script Exposure

Participants receive inhaled medical air combined with exposure to a personalized traumatic script. Four treatment sessions are administered at weekly intervals. During each session, participants undergo 45 minutes of inhalation following the reading of their personalized traumatic script.

Other: Medical Air in Oxygen · Behavioral: Personalized Traumatic Script Exposure

MEOPA (Nitrous Oxide/Oxygen Premix) DRUG

Inhalation of a premixed medicinal gas containing nitrous oxide and oxygen (MEOPA), administered via face mask during four weekly sessions in combination with exposure to a personalized traumatic script.

Medical Air in Oxygen OTHER

Inhalation of medical air administered via face mask during four weekly sessions in combination with exposure to a personalized traumatic script.

Personalized Traumatic Script Exposure BEHAVIORAL

Exposure to an individualized traumatic script written by the participant and read during each treatment session as part of a trauma-focused memory re-exposure procedure. The intervention is administered in combination with either MEOPA or medical air.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Change in PTSD symptom severity measured using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) until 3 months

Plazo: Day 0 and 3 months

The primary endpoint is the change in PTSD symptom severity, as assessed by the CAPS-5 scale, between baseline (Day 0, prior to treatment initiation) and the 3-month follow-up assessment.

Medidas secundarias

Change in PTSD symptom severity using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) until 9 months

Plazo: Day 0, 3 months and 9 months

The secondary endpoint is the change in PTSD symptom severity, as assessed by the CAPS-5 scale, between baseline (Day 0, prior to treatment initiation), 3 months and the 9-month follow-up assessment.

Change in depression severity using the Patient Health Questionnaire-9 (PHQ-9) until 9 months