Trial · NCT04338321
Outcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Remission as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) Score at Week 8 | Week 8 | The full analysis set (FAS) included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Both Remission at Week 8 and Relapse-free Until Week 32 | Week 32 | The FAS includes all randomized participants. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Clinician-rated Overall MADRS Score | Baseline, Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32 | The FAS included all randomized participants. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points. | Unit on scale | MEAN |
| SECONDARY | Change From Baseline in Clinician-rated Overall MADRS Score at Last Observation Carried Forward (LOCF) | Baseline, LOCF at Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32 | The FAS included all randomized participants. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. | Unit on scale | MEAN |
| SECONDARY | Change From Baseline in Clinician-rated Overall Severity of Depressive Illness as Assessed by Clinical Global Impression - Severity (CGI-S) Scale Score | Baseline, Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32 | The FAS included all randomized participants. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points. | Units on scale | MEAN |
| SECONDARY | Change From Baseline in Clinician-rated Overall Severity of Depressive Illness as Assessed by CGI-S Scale Score at LOCF | Baseline, LOCF at Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 32 | The FAS included all randomized participants. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. | Units on scale | MEAN |
| SECONDARY | Clinician-rated Overall Severity of Depressive Illness as Assessed by Clinical Global Impression - Change (CGI-C) Scale Score | Baseline, Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32 | The FAS included all randomized participants. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points. | Units on scale | MEAN |
| SECONDARY | Number of Participants With Clinician-rated Overall Severity of Depressive Illness as Assessed by CGI-C Scale Score at LOCF | Baseline, LOCF at Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 32 | The FAS included all randomized participants. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Participant-reported Depressive Symptoms as Assessed by Patient Health Questionnaire (PHQ) 9-item Total Score | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32 | The FAS included all randomized participants. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points. | Units on scale | MEAN |
| SECONDARY | Change From Baseline in Participant-reported Depressive Symptoms as Assessed by PHQ 9-item Total Score at LOCF | Baseline, LOCF at Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32 | The FAS included all randomized participants. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points. | Units on scale | MEAN |
| SECONDARY | Change From Baseline in Participant-reported Functional Impairment and Associated Disability as Assessed by Sheehan Disability Scale (SDS) Total Score | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32 | The FAS included all randomized participants. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points. | Units on scale | MEAN |
| SECONDARY | Change From Baseline in Participant-reported Functional Impairment and Associated Disability as Assessed by SDS Total Score at LOCF | Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32 | The FAS included all randomized participants. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points. | Units on scale | MEAN |
| SECONDARY | Change From Baseline in Participant-reported Health-related Quality of Life (HRQoL) and Health Status as Assessed by 36-item Short-Form Health Survey (SF-36) Scale Score | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32 | The FAS included all randomized participants. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified categories with time points. | Units on scale | MEAN |
| SECONDARY | Change From Baseline in Participant-reported HRQoL and Health Status as Assessed by SF-36 Scale Score at LOCF | Baseline, LOCF at Weeks 8, 12, 16, 20, 24, 28, 32 | The FAS included all randomized participants. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified categories with time points. LOCF was applied only for participants whose questionnaire was completely missing. No LOCF imputation was done on partially completed questionnaire. | Units on scale | MEAN |
| SECONDARY | Change From Baseline in Participant-reported Quality of Life as Assessed by Quality of Life in Depression Scale (QLDS) Total Score | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32 | The FAS included all randomized participants. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points. | Units on Scale | MEAN |
| SECONDARY | Change From Baseline in Participant-reported Quality of Life as Assessed by QLDS Total Score at LOCF | Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32 | The FAS included all randomized participants. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points. | Units on 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: Health Status Index | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32 | The FAS included all randomized participants. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points. | Units on Scale | MEAN |
| SECONDARY | Change From Baseline in Participant-reported Health-related Quality of Life Group, as Assessed by EQ-5D-5L Score: Health Status Index at LOCF | Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32 | The FAS included all randomized participants. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points. | Units on Scale | MEAN |
| SECONDARY | Change From Baseline in Participant-reported Health Status as Assessed by EQ-5D-5L Score: VAS | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32 | The FAS included all randomized participants. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points. | Units on Scale | MEAN |
| SECONDARY | Change From Baseline in Participant-reported Health Status as Assessed by EQ-5D-5L Score: VAS at LOCF | Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32 | The FAS included all randomized participants. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points. | Units on 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.
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