Depressive EpisodeROSETTENCT05910775
Role Of Non-Specific Effects in The Treatment of Depression With Esketamine
A study testing Pre and Post Treatment Presentations in people with Depressive Episode, run by Yale University at 1 site in United States.
Trial summary
The investigators aim to examine the magnitude of non-specific effects in the treatment of depressive episodes with esketamine, by providing patients in the intervention group with a pretreatment presentation and post-treatment follow up session, to assess whether nonspecific effects can be used effectively to improve… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Episode
- What is being tested?
- Pre and Post Treatment Presentations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participants must be either male or female and at least 18 years old
- Deemed clinically appropriate to receive esketamine by a Yale Interventional Psychiatry physician.
- Written consent for the study procedures
- Ability and willingness, in the investigator's judgement, to comply with the study schedule, treatment plan, and other trial requirements for the duration of the study.
Who cannot join
- Hearing or visual impairment to the degree that would interfere with ability to view the presentation
- Difficulty in understanding spoken or written English
- Unable to provide informed consent
- Dementia or other cognitive disorder or intellectual disability that would impair the subject's ability to understand the presentation (per investigator judgment)
- Any other medical or psychiatric comorbidity that the investigator judges would put the participant at additional undue risk due to study participation or would impair subject's ability to participate in the study.
- Previous Esketamine or ketamine treatment
- Unable to give informed consent
- Was previously enrolled/randomized into the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Psychiatry Hospital Interventional Psychiatry Services (IPS) unit
New Haven, Connecticut, 06520
About this study
The investigators aim to examine the magnitude of non-specific effects in the treatment of depressive episodes with esketamine, by providing patients in the intervention group with a pretreatment presentation and post-treatment follow up session, to assess whether nonspecific effects can be used effectively to improve the effectiveness of treatment with esketamine.
Read the detailed description
Primary Objective:
To determine whether a positive presentation before first treatment improves expectation of improvement from treatment in patients receiving esketamine for a depressive episode within 24 hours after the first treatment.
Secondary Objectives:
To determine whether a post-treatment follow up session to provide encouragement and reassurance improves expectation of improvement from treatment in patients receiving esketamine for a depressive episode within 24 hours after the first treatment.
To determine whether a positive presentation results in an improved response from treatment in patients receiving esketamine for a depressive episode as measured by MADRS score within 24 hours after the first treatment.
To determine whether a positive presentation before first treatment, combined with a posttreatment follow up session after first treatment, result in an improved response from treatment in patients receiving esketamine for a depressive episode as measured by MADRS score by the end of the acute course of esketamine treatment.
- Conditions
- Depressive Episode
- Being tested
- Pre and Post Treatment Presentations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre and Post Treatment PresentationsBehavioural
A short presentation provided to the participants within 72 hours prior to the first treatment of the acute course. The presentation will emphasize the effectiveness of the treatment, and provide notable encouragement and reassurance. The intervention group will additionally receive a follow up session within 24 hours after the first treatment to provide encouragement and reassurance
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual (TAU) | No intervention | Participants receive TAU |
| Intervention + TAU | Experimental | Participants receive a presentation prior to the first treatment and receive a "follow up" session within 24 hours after the first treatment in addition to treatment as usual Receives: Behavioral: Pre and Post Treatment Presentations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group Difference in Change in Question 6 Score on Treatment Credibility and Expectancy Scale (CEQ-6)
Participants' expectations will be assessed by the change in the group score of item 6 of the CEQ-6 at baseline and after the presentation (before treatment 1). Item 6 is scored from 0% (not at all) to 100% (very much). Higher scores indicates expectations have been met.
Measured: baseline and after presentation (before treatment 1), up to 30 days
Secondary outcomes (1)
Group Difference in Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score
MADRS score will be used to assess whether a positive presentation results in an improved response from treatment in participants receiving esketamine for a depressive episode within 24 hours after the first treatment. MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes. Each item is rated on a 0-6 scale, resulting in a maximum total score of 60 points, with higher scores indicative of greater depressive symptomology.
Measured: baseline and within 24 hours post treatment 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start13 Jul 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Why it stopped: The study was suspended due to challenges in recruiting a sufficient number of participants within a reasonable timeframe. Despite our efforts, enrollment did not meet the required threshold to proceed as planned.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Depressive EpisodeStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Model description
- Patients who are deemed clinically appropriate for esketamine will be approached for participation in the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Sina Nikayin, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910775
- Sponsor's protocol ID
- 2000034829
- Other IDs
- 2UL1TR001863-06
- Acronym
- ROSETTE
- Status last verified
- Dec 2025
- First submitted
- 6 Jun 2023
- Last updated
- 14 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role Of Non-Specific Effects in The Treatment of Depression With Esketamine
- ClinicalTrials.gov ID
- NCT05910775
- Acronym / sponsor ID
- ROSETTE / 2000034829
- Conditions
- Depressive Episode
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was suspended due to challenges in recruiting a sufficient number of participants within a reasonable timeframe. Despite our efforts, enrollment did not meet the required threshold to proceed as planned.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 13 Jul 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 20 Jun 2023 (actual)
- Results
- Posted 14 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to examine the magnitude of non-specific effects in the treatment of depressive episodes with esketamine, by providing patients in the intervention group with a pretreatment presentation and post-treatment follow up session, to assess whether nonspecific effects can be used effectively to improve the effectiveness of treatment with esketamine.
Detailed description
Primary Objective:
To determine whether a positive presentation before first treatment improves expectation of improvement from treatment in patients receiving esketamine for a depressive episode within 24 hours after the first treatment.
Secondary Objectives:
To determine whether a post-treatment follow up session to provide encouragement and reassurance improves expectation of improvement from treatment in patients receiving esketamine for a depressive episode within 24 hours after the first treatment.
To determine whether a positive presentation results in an improved response from treatment in patients receiving esketamine for a depressive episode as measured by MADRS score within 24 hours after the first treatment.
To determine whether a positive presentation before first treatment, combined with a posttreatment follow up session after first treatment, result in an improved response from treatment in patients receiving esketamine for a depressive episode as measured by MADRS score by the end of the acute course of esketamine treatment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients who are deemed clinically appropriate for esketamine will be approached for participation in the study.
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual (TAU) | No intervention | –Participants receive TAU |
| Intervention + TAU | Experimental | Behavioral: Pre and Post Treatment PresentationsParticipants receive a presentation prior to the first treatment and receive a "follow up" session within 24 hours after the first treatment in addition to treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must be either male or female and at least 18 years old
- Deemed clinically appropriate to receive esketamine by a Yale Interventional Psychiatry physician.
- Written consent for the study procedures
- Ability and willingness, in the investigator's judgement, to comply with the study schedule, treatment plan, and other trial requirements for the duration of the study.
Key exclusion criteria (8 listed)
- Hearing or visual impairment to the degree that would interfere with ability to view the presentation
- Difficulty in understanding spoken or written English
- Unable to provide informed consent
- Dementia or other cognitive disorder or intellectual disability that would impair the subject's ability to understand the presentation (per investigator judgment)
- Any other medical or psychiatric comorbidity that the investigator judges would put the participant at additional undue risk due to study participation or would impair subject's ability to participate in the study.
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 |
|---|---|---|
| Pre and Post Treatment PresentationsA short presentation provided to the participants within 72 hours prior to the first treatment of the acute course. The presentation will emphasize the effectiveness of the treatment, and provide notable encouragement and reassurance. The intervention group will additionally receive a follow up session within 24 hours after the first treatment to provide encouragement and reassurance | Behavioural | Intervention + TAU |
Primary outcome
Group Difference in Change in Question 6 Score on Treatment Credibility and Expectancy Scale (CEQ-6)
Time frame: baseline and after presentation (before treatment 1), up to 30 days
Participants' expectations will be assessed by the change in the group score of item 6 of the CEQ-6 at baseline and after the presentation (before treatment 1). Item 6 is scored from 0% (not at all) to 100% (very much). Higher scores indicates expectations have been met.
1 secondary outcome
Group Difference in Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score
Time frame: baseline and within 24 hours post treatment 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Sina Nikayin, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre and Post Treatment Presentations in people with Depressive Episode, run by Yale University at 1 site in United States.
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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 14 Jan 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 United States. 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?
Yes. Results are posted in the registry (first posted 14 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Group Difference in Change in Question 6 Score on Treatment Credibility and Expectancy Scale (CEQ-6) (time frame: baseline and after presentation (before treatment 1), up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2026.