Phenomenological Explorations of the Esketamine-Induced Transient Dissociative State

Depressive Disorder Clinical Trial

— EXPEDIE  

Official title:

Phenomenological Explorations of the Esketamine-Induced Transient Dissociative State

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06133309
• Other study ID #: 2023-CHITS-008
• Secondary ID: 2023-A01528-37
• Status: Recruiting
• Phase: N/A
• Start date: March 19, 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Contact: Sophie LAFOND
• Phone: 0483772062
• Email: sophie.lafond[@]ch-toulon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal Toulon La Seyne sur Mer	Toulon	Var

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consciousness fluidity evaluation by Experiential phenomenological interviews	Qualitative assessment by Experiential phenomenological interviews.	1 day
Secondary	Consciousness fluidity evaluation by EQFC "Trait" questionnaire	Qualitative assessment by EQFC "Trait" questionnaire.	1 day

External Links

•   EQFC Questionnaire