Trial · NCT03434041
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score to the End of Double-blind Treatment Phase (Day 28) | Baseline up to end of the double-blind treatment phase (Day 28) | Full analysis set included all randomized participants who received a least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind treatment phase. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Units on a Scale | MEAN |
| SECONDARY | Change From Baseline in Depressive Symptoms as Measured by the MADRS Total Score to 24 Hours Post First Dose (Day 2) | Baseline (Day 1: predose) to 24 hours post first dose (Day 2) | Full analysis set included all randomized participants who received a least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind treatment phase. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Units on a Scale | MEAN |
| SECONDARY | Change From Baseline in Sheehan Disability Scale (SDS) Total Score to the End of Double-blind Treatment Phase (Day 28) | Baseline up to end of the double-blind treatment phase (Day 28) | Full analysis set included all randomized participants who received a least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind treatment phase. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Units on a Scale | MEAN |
| SECONDARY | Percentage of Participants With Onset of Clinical Response | Day 2 up to Day 28 | Full analysis set included all randomized participants who received a least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind treatment phase. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Responders at the End of Double-blind Treatment Phase (Day 28) | Day 28 | Full analysis set included all randomized participants who received a least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind treatment phase. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Percentage of Responders | NUMBER |
| SECONDARY | Percentage of Participants in Remission at the End of Double-blind Treatment Phase (Day 28) | Day 28 | Full analysis set included all randomized participants who received a least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind treatment phase. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Sustained Remission | Up to Day 28 | Full analysis set included all randomized participants who received a least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind treatment phase. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Score up to the Endpoint (Double-blind Treatment Phase [Day 28]) | Baseline up to Double-blind Endpoint (Day 28) | Full analysis set included all randomized participants who received a least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind treatment phase. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Units on a Scale | MEDIAN |
| SECONDARY | Change From Baseline in Generalized Anxiety Disorder 7-item (GAD-7) Scale Score up to the Endpoint (Double-blind Treatment Phase [Day 28]) | Baseline up to Endpoint (double-blind treatment phase [Day 28]) | Full analysis set included all randomized participants who received a least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind treatment phase. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Units on a Scale | MEAN |
| SECONDARY | 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 | Baseline up to Double-blind Endpoint (Day 28) | Full analysis set included all randomized participants who received a least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind treatment phase. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Units on a Scale | MEAN |
| SECONDARY | Change From Baseline in Participant-Reported Health Status as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) Score up to the Endpoint (Double-blind Treatment Phase [Day 28]): Visual Analogue Scale (VAS) | Baseline up to Double-blind Endpoint (Day 28) | Full analysis set included all randomized participants who received a least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind treatment phase. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Units on a Scale | MEAN |
| SECONDARY | Change From Baseline in Participant-Reported Health Status as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) up to the Endpoint (Double-blind Treatment Phase [Day 28]): Sum Score | Baseline up to Double-blind Endpoint (Day 28) | Full analysis set included all randomized participants who received a least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind treatment phase. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Units on a Scale | MEAN |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03434041/outcomes