Trial · NCT01436175
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 5 up to Week 52/Early Termination(ET) | Safety analysis set included all participants who took at least 1 dose of investigational product and had at least 1 post-Visit 0 (Week 0) safety assessment in this study | participants | NUMBER |
| PRIMARY | Change From Baseline in Systolic Blood Pressure at Week 52 | Baseline, Week 52/ET | Safety Analysis Set. Here n = participants evaluable at specified time-points. | millimeter of mercury(mmHg) | MEAN |
| PRIMARY | Change From Baseline in Diastolic Blood Pressure at Week 52 | Baseline, Week 52/ET | Safety Analysis Set. Here n = participants evaluable at specified time-points. | mmHg | MEAN |
| PRIMARY | Change From Baseline in Pulse Rate at Week 52 | Baseline, Week 52/ET | Safety Analysis Set. Here n = participants evaluable at specified time-points. | beats per minute(bpm) | MEAN |
| SECONDARY | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 52/ET | Baseline, Week 52/ET | Full Analysis Set (FAS) included all participants in the Safety Analysis Set who had at least 1 clinical experience outcome assessment in the study. Here n = participants evaluable at specified time-points. | units on a scale | MEAN |
| SECONDARY | Number of Participants With Improvement on Clinical Global Impressions - Global Improvement (CGI-I) | Week 52/ET | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure. | participants | NUMBER |
| SECONDARY | Short Form-12 Health Survey Version 2 (SF-12V2) | Week 52/ET | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility | Week 52/ET | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure. | participants | NUMBER |
| SECONDARY | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care | Week 52/ET | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure. | participants | NUMBER |
| SECONDARY | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities | Week 52/ET | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure. | participants | NUMBER |
| SECONDARY | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Pain/Discomfort | Week 52/ET | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure. | participants | NUMBER |
| SECONDARY | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Anxiety/Depression | Week 52/ET | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure. | participants | NUMBER |
| SECONDARY | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Visual Analog Scale | Week 52/ET | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) | Week 52/ET | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure | units on a scale | MEAN |
| SECONDARY | Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF) | Week 52/ET | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score at Week 52/ET | Baseline, Week 52/ET | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories. | units on a scale | MEAN |
| SECONDARY | Amphetamine Cessation Symptom Assessment (ACSA) Total Score | Week 53 | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD) | Week 52/ET | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure | participants | NUMBER |
| SECONDARY | PRUQ-MDD - Number of Days of Resource Utilization | Week 52/ET | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories. | days | MEAN |
| SECONDARY | PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed) | Week 52/ET | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories | events | 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/NCT01436175/outcomes