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Completed

NCT Number: NCT06133309

Phenomenological Explorations of the Esketamine-Induced Transient Dissociative State

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Toulon, Var, 83100, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experiential Phenomenological Interview

Behavioral

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

Primary outcomes

  1. Consciousness fluidity evaluation by Experiential phenomenological interviews

    Time frame: 1 day

    Qualitative assessment by Experiential phenomenological interviews.

Secondary outcomes

  1. Consciousness fluidity evaluation by EQFC "Trait" questionnaire

    Time frame: 1 day

    Qualitative assessment by EQFC "Trait" questionnaire.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Other

Registry information

Acronym: EXPEDIE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 15, 2023
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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