Trial · NCT04221230
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Hamilton Depression Rating Scale (HAMD-17) Total Score at Weeks 8 | Baseline and at Week 8 | Final Efficacy population comprised of the Full Efficacy population but excluded 5 subjects from a single site due to GCP noncompliance that compromised data integrity. Only those participants with data available at specified time points has been presented. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical Global Impression of Improvement (CGI-I) Score | At Week 8 | Final Efficacy Population. Only those participants with data available at specified timepoints has been presented. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Score | Baseline and at Week 8 | Final Efficacy Population. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Subscales (ie, Anxiety Subscale [HADS-A] and Depression Subscale [HADS-D]) Scores | Baseline and at Week 8 | Final Efficacy Population. Only those participants with data available at specified timepoints has been presented. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score | Baseline and at Week 8 | Final Efficacy Population. Only those participants with data available at specified timepoints has been presented. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Sheehan Disability Scale (SDS) Scores | Baseline and at Week 8 | Final Efficacy Population. Only those participants with data available at specified timepoints has been presented. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 8 in Clinical Global Impression Scale - Severity (CGI-S) Scores | Baseline and at Week 8 | Final Efficacy Population. Only those participants with data available at specified timepoints has been presented. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With a HAMD-17 Response | At Week 8 | Final Efficacy Population. Only those participants with data available at specified timepoints has been presented | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants Reporting >2% Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) | Up to 8 Weeks | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Changes in Hematology Parameters | Up to 8 Weeks | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Changes in Clinical Chemistry Parameters | Up to 8 Weeks | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Changes in Urinary Parameters | Up to 8 Weeks | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Changes in Vital Parameters | Up to 8 Weeks | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters | Up to 8 Weeks | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Changes in Physical Examinations | Up to 8 Weeks | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Changes in Ophthalmologic Examination Findings | Up to 8 Weeks | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Reporting Suicidal Behaviors or Ideation As Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) | At Week 8 | Safety Population who completed C-SSRS at Week 8 has been presented. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Reporting Clinically Significant Response to Clinical Opiate Withdrawal Scale (COWS) | At Week 8 | Safety Population who completed COWS at Week 8 has been presented. | Participants | COUNT_OF_PARTICIPANTS |
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/NCT04221230/outcomes