Trial · NCT04442503
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 (CFB) in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 | Baseline and Day 15 | Full Analysis Set(FAS)=randomized participants who received any amount of IP and had valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM for Anxiety(HAM-A), Montgomery Åsberg Depression Rating Scale(MADRS), Clinical Global Impressions-Severity(CGI-S), Edinburgh Postnatal Depression Scale(EPDS) and Patient Health Questionnaire(PHQ-9), or at least 1 post-baseline value of CGI-I. Number analyzed=number of participants with data available for analyses. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the 17-item HAM-D Total Score | Baseline, Days 3, 28 and 45 | FAS included all randomized participants who received any amount of IP and had valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I. Number analyzed is the number of participants with data available for analysis. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impressions - Severity Scale (CGI-S) Score | Baseline and Day 15 | FAS included all randomized participants who received any amount of IP and had valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I. Number analyzed is the number of participants with data available for analyses. | score on a scale | MEAN |
| SECONDARY | Percentage of Participants With HAM-D Response | Days 15 and 45 | FAS included all randomized participants who received any amount of IP and had valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I. Number analyzed is the number of participants available for analyses. Percentages are rounded off to the nearest whole number. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HAM-D Remission | Days 15 and 45 | FAS included all randomized participants who received any amount of IP and had valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I. Number analyzed is the number of participants with data available for analyses. Percentages are rounded off to the nearest whole number. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response | Day 15 | FAS included all randomized participants who received any amount of IP and had valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I. Overall number analyzed is the number of participants available for analyses. Number analyzed is the number of participants with data available for analyses. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Hamilton Rating Scale for Anxiety (HAM-A) Total Score | Baseline and Day 15 | FAS included all randomized participants who received any amount of IP and had valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I. Number of participants analyzed is the number of participants with data available for analyses. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score | Baseline and Day 15 | FAS included all randomized participants who received any amount of IP and had valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I. Overall number analyzed are the number of participants available for analysis. Number analyzed is the number of participants with data available for analyses. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in HAM-D Subscale | Baseline and Day 15 | FAS included all randomized participants who received any amount of IP and had valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I. Number analyzed is the number of participants with data available for analyses. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Self-Reported Measures of Depressive Symptoms, as Assessed by the Edinburgh Postnatal Depression Scale (EPDS) Total Score | Baseline, Days 3, 8,15, 21, 28 and 45 | FAS included all randomized participants who received any amount of IP and had valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I. Number analyzed is the number of participants with data available for analyses. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Self-Reported Measures of Depressive Symptoms, as Assessed by the 9-item Patient Health Questionnaire (PHQ-9) Score | Baseline, Days 3, 8,15, 21, 28 and 45 | FAS included all randomized participants who received any amount of IP and had valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I. Number analyzed are the number of participants with data available for analysis. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | Up to Day 45 | Safety Set included all participants who were administered IP. | percentage of participants | NUMBER |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04442503/outcomes