Phenomenological Explorations of the Esketamine-Induced Transient

Status Recruiting

Clinical Trial Summary

Ketamine is an anaesthetic used in low doses to treat depressive disorders. A related molecule, Esketamine, has recently been launched on the market for the treatment of resistant depression. One of the side effects of ketamine, like Esketamine, is induction of transient dissociative state. Dissociation has been described as disruption in continuity of conscious thought and emotion, cognitive processes disorganisation and an alteration in self-perception and environment perception. A study of healthy volunteers receiving ketamine showed that this state was manifested by altered sensory perceptions, with increased noise sensitivity, visual distortions and altered time perception. Few studies have looked at this phenomenon in the Esketamine context. However, it is a frequent side effect. With ketamine, it has been shown that anxiety associated with dissociative experience reduces the antidepressant effect. Benzodiazepines use for anxiolytic purposes is also thought to limit the antidepressant effect. It is necessary to explore the Esketamine induced transient dissociative state in order to clarify this state and develop therapeutic strategies. The investigators have chosen a phenomenological approach, which is the only way to evaluate consciousness contents and structures, in order to explore this state using the experiential phenomenological interview.

Clinical Trial Description

Patients will be identified when they come for an Esketamine session performed as part of routine practice in the Psychiatry Department of Hôpital Sainte Musse. The clinician, who is also the study investigator, will then select patients who meet the protocol's inclusion criteria and inform them of the research before administering the Esketamine. He will explain the study in detail and give them the information letter. Patients will then be seen again in consultation outside the Esketamine sessions, as part of routine practice, within a minimum of 48 hours. During this consultation, the investigating physician will obtain their oral consent to their participation in the research, resulting in a research consultation lasting around 45 minutes and including : - an audio recording of an Experiential Phenomenological Interview; - completion of the EQFC "Trait" questionnaire. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06133309
Study type	Interventional
Source	Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Contact	Sophie LAFOND
Phone	0483772062
Email	sophie.lafond@ch-toulon.fr
Status	Recruiting
Phase	N/A
Start date	March 19, 2024
Completion date	December 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Phenomenological Explorations of the Esketamine-Induced Transient Dissociative State — EXPEDIE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms