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CompletedNot applicable

Phenomenological Explorations of the Esketamine-Induced Transient Dissociative State

NCT06133309 · EXPEDIE · Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Closed to entry
Status
Not accepting participants
Not applicable
Phase
15
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Consciousness fluidity evaluation by Experiential phenomenological interviews

    Measured over 1 day

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Patient followed in the Psychiatry Department of Hôpital Sainte Musse, with depressive state characterized by the DSM-V criteria and treated with Esketamine between 2 days and 3 months prior to the study; * Patient over the age of 18; * Patient presented transient dissociative state during Esketamine treatment; * Patient able to express his/her consent prior to participation in the study; * Patient who understands and speaks French. Exclusion Criteria: * Patient with major anxiety and panic attack during an Esketamine-induced dissociative state, regardless of Esketamine effect; * Patient under judicial protection (guardianship, curatorship...) or safeguard of justice; * Pregnant, parturient or breast-feeding women; * Any other reason that, in the opinion of the investigator, would interfere with the evaluation of the study objectives.

Where

1 study site

FacilityCityRegionCountry
Centre Hospitalier Intercommunal Toulon La Seyne sur MerToulonVarFrance

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT06133309 on ClinicalTrials.gov →

Last updated in the registry 2026-07-07. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits