Trial · NCT05455684
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Day 43 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Baseline (Day 1) to Day 43 | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Day 43 in Dimensional Anhedonia Rating Scale (DARS) Total Score | Baseline (Day 1) to Day 43 | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline Over Time in MADRS Total Score | Baseline (Day 1), Days 15, 29 and 43 | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Achieved Response on Depressive Symptoms Scale Based on MADRS Total Score at Day 43 | At Day 43 | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Remission of Depressive Symptoms Based on MADRS Total Score at Day 43 | At Day 43 | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Day 43 in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score | Baseline (Day 1) to Day 43 | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline Over Time in DARS Total Score | Baseline (Day 1), Days 15, 29, and 43 | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline Over Time in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) | Baseline (Day 1), Day 15, Day 29, and Day 43 | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. | Units on a scale | MEAN |
| SECONDARY | Percentage of Participants With a Score Less Than (<) 2 in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) at Day 43 | At Day 43 | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline Over Time in Patient Reported Outcomes Measurement Information System Short Form - Ability to Participate in Social Roles and Activities - 8a (PROMIS-APS 8a) | Baseline (Day 1), Days 15, 29, and 43 | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. | T-score | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline Over Time in Work Productivity and Activity Impairment: Depression (WPAI:D) | Baseline (Day 1), Days 29 and 43 | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. As planned overall work impairment (absenteeism plus presenteeism) and activity impairment is reported. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | DB Treatment Phase: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | From start of treatment (Day 1) up to Day 43 | Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study intervention. | Percentage of participants | NUMBER |
| SECONDARY | Follow-up (FU) Phase: Percentage of Participants With AEs | From Day 44 up to Day 57 | Follow-up analysis set included all randomized participants who entered the follow-up phase after the double-blind treatment phase. | Percentage of participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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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