Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

1 to 12 of 12

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline at 60 Hours in 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score	Baseline, Hour 60	All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Overall number of participants analyzed is the number of participants with data available for analysis at the given time-point.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in HAM-D Total Score at Day 30	Baseline, Day 30	All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Overall number of participants analyzed is the number of participants with data available for analysis at the given time-point.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in HAM-D Total Score	Baseline, Hours 2, 4, 8, 12, 24, 36, 48, 72, and Days 7, 14 and 21	All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With HAM-D Response	Hour 60, Days 7 and 30	All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With HAM-D Remission	Hour 60, Days 7 and 30	All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in HAM-D Bech 6 Subscale	Baseline, Hour 60, Days 7 and 30	All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in HAM-D Individual Item Scores	Baseline, Hours 2, 4, 8, 12, 24, 36, 48, 60, 72, and Days 7, 14, 21, and 30	All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline at Key Time Points in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score	Baseline, Hour 60, Days 7 and 30	All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.	score on a scale	MEAN
SECONDARY	Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response	Hour 60, Days 7 and 30	All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score	Baseline, Hour 60, Days 7, 14, 21 and 30	All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With Treatment Emergent Adverse Event (TEAE)	Up to approximately 37 days	The safety set included all randomized participants who started the study drug infusion.	percentage of participants	NUMBER
SECONDARY	Time to Change in Antidepressant Medication	Up to approximately 37 days	All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.	days	MEDIAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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