Phenomenological Explorations of the Esketamine-Induced Transient Dissociative State

NCT06133309 | Completed

• 2 other identifiers: 2023-CHITS-0082023-A01528-37
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depressive Disorder

Keywords

Depressive disorder; Experiential Phenomenological Interview; Eskétamine; Transient dissociative state; Consciousness contents

Outcome Measures

Primary Outcomes (1)

• Consciousness fluidity evaluation by Experiential phenomenological interviews

  Qualitative assessment by Experiential phenomenological interviews.

  1 day

Secondary Outcomes (1)

• Consciousness fluidity evaluation by EQFC "Trait" questionnaire

  1 day

Study Arms (1)

Depressive patients

EXPERIMENTAL

Patients suffering from depressive disorder and treated with Esketamine between 2 days and 3 months prior to the study.

Behavioral: Experiential Phenomenological Interview

Interventions

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

Depressive patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (1)

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Toulon, Var, 83100, France

Location

Related Publications (4)

• Holmes EA, Brown RJ, Mansell W, Fearon RP, Hunter EC, Frasquilho F, Oakley DA. Are there two qualitatively distinct forms of dissociation? A review and some clinical implications. Clin Psychol Rev. 2005 Jan;25(1):1-23. doi: 10.1016/j.cpr.2004.08.006.

  PMID: 15596078 BACKGROUND

• McIntyre RS, Rosenblat JD, Nemeroff CB, Sanacora G, Murrough JW, Berk M, Brietzke E, Dodd S, Gorwood P, Ho R, Iosifescu DV, Lopez Jaramillo C, Kasper S, Kratiuk K, Lee JG, Lee Y, Lui LMW, Mansur RB, Papakostas GI, Subramaniapillai M, Thase M, Vieta E, Young AH, Zarate CA Jr, Stahl S. Synthesizing the Evidence for Ketamine and Esketamine in Treatment-Resistant Depression: An International Expert Opinion on the Available Evidence and Implementation. Am J Psychiatry. 2021 May 1;178(5):383-399. doi: 10.1176/appi.ajp.2020.20081251. Epub 2021 Mar 17.

  PMID: 33726522 BACKGROUND

• Aust S, Gartner M, Basso L, Otte C, Wingenfeld K, Chae WR, Heuser-Collier I, Regen F, Cosma NC, van Hall F, Grimm S, Bajbouj M. Anxiety during ketamine infusions is associated with negative treatment responses in major depressive disorder. Eur Neuropsychopharmacol. 2019 Apr;29(4):529-538. doi: 10.1016/j.euroneuro.2019.02.005. Epub 2019 Feb 13.

  PMID: 30772118 BACKGROUND

• Pereira S, Brennan E, Patel A, Moran M, Wallier J, Liebowitz MR. Managing dissociative symptoms following the use of esketamine nasal spray: a case report. Int Clin Psychopharmacol. 2021 Jan;36(1):54-57. doi: 10.1097/YIC.0000000000000327.

  PMID: 32804743 BACKGROUND

Related Links

• EQFC Questionnaire

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• Manuel DIAS ALVES, MD PhD

  Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 15, 2023
• Study Start: March 19, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)