Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, Var, 83100, France
NCT Number: NCT06133309
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Toulon, Var, 83100, France
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 :
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Consciousness fluidity of patients suffering from depressive disorder and treated with Esketamine will be evaluated thanks to Experiential Phenomenological Interview and EQFC "Trait" questionnaire
Time frame: 1 day
Qualitative assessment by Experiential phenomenological interviews.
Time frame: 1 day
Qualitative assessment by EQFC "Trait" questionnaire.
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Other
Acronym: EXPEDIE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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