Trial · NCT01436162
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
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 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 | Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score at 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 | Percent 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 | 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 MADRS total score after the Augmentation Baseline Visit (Visit 8). Sample size (n) of MADRS total score at each visit differed from sample size (N) of the FAS. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Abbreviated Brief Assessment of Cognition Affective Disorders (ABAC-A) Composite T-Scores | 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). | t-score | 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 in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score Male | Up to 8 weeks | Full Analysis Set: Male 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 |
| SECONDARY | Mean Change in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score Female | Up to 8 weeks | Full Analysis Set: Female 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 |
| 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 | Mean Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Global Fatigue Index (GFI) | 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 | Columbia Suicide Severity Rating Scale (C-SSRS) | Up to 8 weeks | Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 safety assessment (e.g., coming back for any visit, reporting of an adverse event \[AE\], or reporting the absence of AEs) after the Augmentation Baseline Visit (Visit 8). | percentage of participants | NUMBER |
| SECONDARY | Amphetamine Cessation Symptom Assessment (ACSA) - Total Aggregate Score | 8 weeks | Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 safety assessment (e.g., coming back for any visit, reporting of an AE, or reporting the absence of AEs) after the Augmentation Baseline Visit (Visit 8). | Score | 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/NCT01436162/outcomes