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Trial · NCT03434041

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score to the End of Double-blind Treatment Phase (Day 28)Intranasal Esketamine + Oral Antidepressant (AD)-10.1Standard Deviation 10.80Units on a Scale
Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score to the End of Double-blind Treatment Phase (Day 28)Intranasal Placebo + Oral AD-8.1Standard Deviation 10.26Units on a Scale
Change From Baseline in Depressive Symptoms as Measured by the MADRS Total Score to 24 Hours Post First Dose (Day 2)Intranasal Esketamine + Oral Antidepressant (AD)-8.0Standard Deviation 9.01Units on a Scale
Change From Baseline in Depressive Symptoms as Measured by the MADRS Total Score to 24 Hours Post First Dose (Day 2)Intranasal Placebo + Oral AD-4.4Standard Deviation 7.66Units on a Scale
Change From Baseline in Sheehan Disability Scale (SDS) Total Score to the End of Double-blind Treatment Phase (Day 28)Intranasal Esketamine + Oral Antidepressant (AD)-6.3Standard Deviation 7.54Units on a Scale
Change From Baseline in Sheehan Disability Scale (SDS) Total Score to the End of Double-blind Treatment Phase (Day 28)Intranasal Placebo + Oral AD-5.3Standard Deviation 7.03Units on a Scale
Percentage of Participants With Onset of Clinical ResponseIntranasal Esketamine + Oral Antidepressant (AD)6.5Percentage of participants
Percentage of Participants With Onset of Clinical ResponseIntranasal Placebo + Oral AD1.6Percentage of participants
Percentage of Responders at the End of Double-blind Treatment Phase (Day 28)Intranasal Esketamine + Oral Antidepressant (AD)19.3Percentage of Responders
Percentage of Responders at the End of Double-blind Treatment Phase (Day 28)Intranasal Placebo + Oral AD16.0Percentage of Responders
Percentage of Participants in Remission at the End of Double-blind Treatment Phase (Day 28)Intranasal Esketamine + Oral Antidepressant (AD)12.8Percentage of Participants
Percentage of Participants in Remission at the End of Double-blind Treatment Phase (Day 28)Intranasal Placebo + Oral AD10.4Percentage of Participants
Percentage of Participants With Sustained RemissionIntranasal Esketamine + Oral Antidepressant (AD)5.6Percentage of Participants
Percentage of Participants With Sustained RemissionIntranasal Placebo + Oral AD6.3Percentage of Participants
Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Score up to the Endpoint (Double-blind Treatment Phase [Day 28])Intranasal Esketamine + Oral Antidepressant (AD)-1.0Full Range -5 to 1Units on a Scale
Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Score up to the Endpoint (Double-blind Treatment Phase [Day 28])Intranasal Placebo + Oral AD-1.0Full Range -5 to 1Units on a Scale
Change From Baseline in Generalized Anxiety Disorder 7-item (GAD-7) Scale Score up to the Endpoint (Double-blind Treatment Phase [Day 28])Intranasal Esketamine + Oral Antidepressant (AD)-4.3Standard Deviation 5.65Units on a Scale
Change From Baseline in Generalized Anxiety Disorder 7-item (GAD-7) Scale Score up to the Endpoint (Double-blind Treatment Phase [Day 28])Intranasal Placebo + Oral AD-2.9Standard Deviation 5.28Units on a Scale
Change From Baseline in Participant-Reported Health-Related Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) Score up to the Endpoint (Double-blind Treatment Phase [Day 28]): Health Status Index
Intranasal Esketamine + Oral Antidepressant (AD)0.152Standard Deviation 0.2294Units on a Scale
Change From Baseline in Participant-Reported Health-Related Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) Score up to the Endpoint (Double-blind Treatment Phase [Day 28]): Health Status Index
Intranasal Placebo + Oral AD0.103Standard Deviation 0.2084Units on a Scale

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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