Trial · NCT01436149
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 | Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at up to 8 Weeks | 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at up to 8 Weeks | 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving a 25% Response on the MADRS | up to 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a 50% Response on the MADRS | up to 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Remission on the MADRS | up to 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline Over Time in MADRS Total Score | Baseline and up to 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR) | up to 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in the Short Form-12 Health Survey V2 (SF-12V2) | up to 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in the Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF) | up to 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical Global Impressions - Global Improvement (CGI-I) | up to 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | percentage of participants | NUMBER |
| SECONDARY | Columbia Suicide Severity Rating Scale (C-SSRS) | up to 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | percentage of participants | NUMBER |
| SECONDARY | Amphetamine Cessation Symptom Assessment (ACSA) | up to 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | units on a 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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01436149/outcomes