Trial Outcomes & Findings for Role Of Non-Specific Effects in The Treatment of Depression With Esketamine (NCT NCT05910775)
NCT ID: NCT05910775
Last Updated: 2026-01-14
Results Overview
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.
TERMINATED
NA
1 participants
baseline and after presentation (before treatment 1), up to 30 days
2026-01-14
Participant Flow
The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Participant milestones
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Treatment as Usual (TAU)
Participants receive TAU
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Intervention + TAU
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
Pre and Post Treatment Presentations: 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
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Overall Study
STARTED
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Overall Study
COMPLETED
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0
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0
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Role Of Non-Specific Effects in The Treatment of Depression With Esketamine
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: baseline and after presentation (before treatment 1), up to 30 daysPopulation: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and within 24 hours post treatment 1Population: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
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.
Outcome measures
Outcome data not reported
Adverse Events
Treatment as Usual (TAU)
Intervention + TAU
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place