Depressive DisorderEXPEDIENCT06133309
Phenomenological Explorations of the Esketamine-Induced Transient Dissociative State
A study testing Experiential Phenomenological Interview in people with Depressive Disorder, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Experiential Phenomenological Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, Var, 83100
About this study
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.
Read the detailed 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.
- Conditions
- Depressive Disorder
- Being tested
- Experiential Phenomenological Interview
- Keywords
- Depressive disorder, Experiential Phenomenological Interview, Eskétamine, Transient dissociative state, Consciousness contents
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experiential Phenomenological InterviewBehavioural
Consciousness fluidity of patients suffering from depressive disorder and treated with Esketamine will be evaluated thanks to Experiential Phenomenological Interview and EQFC "Trait" questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Depressive patients | Experimental | Patients suffering from depressive disorder and treated with Esketamine between 2 days and 3 months prior to the study. Receives: Behavioral: Experiential Phenomenological Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consciousness fluidity evaluation by Experiential phenomenological interviews
Qualitative assessment by Experiential phenomenological interviews.
Measured: 1 day
Secondary outcomes (1)
Consciousness fluidity evaluation by EQFC "Trait" questionnaire
Qualitative assessment by EQFC "Trait" questionnaire.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start19 Mar 2024
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuel DIAS ALVES, MD PhD, Study director, Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133309
- Sponsor's protocol ID
- 2023-CHITS-008
- Other IDs
- 2023-A01528-37
- Acronym
- EXPEDIE
- Status last verified
- Jul 2026
- First submitted
- 10 Nov 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15596078McIntyre 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.
PubMed 33726522Aust 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.
PubMed 30772118Pereira 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.
PubMed 32804743
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenomenological Explorations of the Esketamine-Induced Transient Dissociative State
- ClinicalTrials.gov ID
- NCT06133309
- Acronym / sponsor ID
- EXPEDIE / 2023-CHITS-008
- Conditions
- Depressive Disorder
- Keywords
- Depressive disorder, Experiential Phenomenological Interview, Eskétamine, Transient dissociative state, Consciousness contents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Depressive patients | Experimental | Behavioral: Experiential Phenomenological InterviewPatients suffering from depressive disorder and treated with Esketamine between 2 days and 3 months prior to the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experiential Phenomenological InterviewConsciousness fluidity of patients suffering from depressive disorder and treated with Esketamine will be evaluated thanks to Experiential Phenomenological Interview and EQFC "Trait" questionnaire | Behavioural | Depressive patients |
Primary outcome
Consciousness fluidity evaluation by Experiential phenomenological interviews
Time frame: 1 day
Qualitative assessment by Experiential phenomenological interviews.
1 secondary outcome
Consciousness fluidity evaluation by EQFC "Trait" questionnaire
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 15596078Holmes 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.
- Background: PubMed 33726522McIntyre 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.
- Background: PubMed 30772118Aust 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.
- Background: PubMed 32804743Pereira 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.
- EQFC QuestionnaireLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel DIAS ALVES, MD PhD study director
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experiential Phenomenological Interview in people with Depressive Disorder, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consciousness fluidity evaluation by Experiential phenomenological interviews (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06133309, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.