NCT06133309

Phenomenological Explorations of the Esketamine-Induced Transient Dissociative State

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Depressive Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Experiential Phenomenological Interview	Consciousness fluidity of patients suffering from depressive disorder and treated with Esketamine will be evaluated thanks to Experiential Phenomenological Interview and EQFC "Trait" questionnaire

Timeline

• Start date: 2024-03-19
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-11-15
• Last updated: 2026-04-13

Locations

1 site across 1 country: France