Trial · NCT01328093
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to 24 Weeks in Body Weight | Baseline, 24 weeks | Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had baseline and at least one post-baseline weight measurement, excluding participants from the excluded study site. | kilograms (kg) | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Clinically Significant Weight Change | Baseline up to 24 weeks | Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline weight measurement, excluding participants from the excluded study site. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline up to 24 Weeks in Barnes Akathisia Scale (BAS) | Baseline, 24 weeks | Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline BAS global score measurement, excluding participants from the excluded study site. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline up to 24 Weeks in Simpson-Angus Scale (SAS) | Baseline, 24 weeks | Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline SAS total score measurement, excluding participants from the excluded study site. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline up to 24 Weeks in Abnormal Involuntary Movement Scale (AIMS) | Baseline, 24 weeks | Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline AIMS 1-7 Total Score measurement, excluding participants from the excluded study site. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline up to 24 Weeks in Positive and Negative Syndrome Scale (PANSS) Total and Subscale Scores | Baseline, 24 weeks | Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline PANSS measurement, excluding participants from the excluded study site. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline up to 24 Weeks in EuroQol-5 Dimensions Questionnaire (EQ-5D) Visual Analog Scale (VAS) Health State Score | Baseline, 24 weeks | Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline VAS health state measurement, excluding participants from the excluded study site. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Schizophrenia Resource Utilization Module (S-RUM) - Number of Emergency Room (ER) or Equivalent Facility Visits and Outpatient Medical Visits | Baseline to 24 weeks | Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug and had S-RUM assessment, excluding participants from the excluded study site. Last observation carried forward (LOCF) principle was used. | visits | LEAST_SQUARES_MEAN |
| SECONDARY | Schizophrenia Resource Use Module (S-RUM) - Number of Sessions With a Psychiatrist | Baseline to 24 weeks | Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug and had S-RUM assessment, excluding participants from the excluded study site. Last observation carried forward (LOCF) principle was used. | sessions | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline up to 24 Weeks in Subjective Well-Being Under Neuroleptic Treatment Scale- Short Form (SWN-SF) Total Score | Baseline, 24 weeks | Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline SWN-SF Total Score measurement, excluding participants from the excluded study site. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline up to 24 Weeks in Personal and Social Performance (PSP) Score | Baseline, 24 weeks | Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline PSP measurement, excluding participants from the excluded study site. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline up to 24 Weeks in Clinical Global Impression-Severity Scale (CGI-S) | Baseline, 24 weeks | Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline CGI-S measurement, excluding participants from the excluded study site. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline up to 24 Weeks in 16-Item Negative Symptom Assessment (NSA-16) | Baseline, 24 weeks | Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline NSA-16 Total Score measurement, excluding participants from the excluded study site. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With 30% or Greater Decrease in Positive and Negative Syndrome Scale (PANSS) Total Score | Baseline up to 24 weeks | Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline PANSS measurement, excluding participants from the excluded study site. Last observation carried forward (LOCF) principle was used. | participants | NUMBER |
| SECONDARY | Number of Participants With Suicidal Behaviors and Ideations Measured by Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline to 24 weeks | Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline C-SSRS measurement, excluding participants from the excluded study site. | participants | NUMBER |
| SECONDARY | Time to Discontinuation | Randomization up to 24 weeks | Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, excluding participants from the excluded study site. Participants who completed the study were considered censored: 229 for LY2140023 group and 84 for Aripiprazole group. | days | MEDIAN |
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/NCT01328093/outcomes