Trial · NCT01307800
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score | Baseline, Week 6 | Pts in efficacy-evaluable intent-to-treat (EE-ITT) population (received at least 1 dose of study drug and not placebo lead-in responders) who had baseline and at least 1 post-baseline PANSS total score. Excluded were pts with missing predefined subpopulation data. Placebo lead-in responder had ≥25% PANSS total score improvement in lead-in period. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score in a Predefined Subpopulation of Schizophrenia Participants | Baseline, Week 6 | EE-ITT participants (see Outcome Measure 1 for population definition) in the predefined subpopulation who had a baseline and at least 1 post-baseline PANSS total score. The predefined subpopulation excluded non-Hispanic whites (self-reported) who had A/A genotype at the serotonin 2A receptor (HTR2A) single nucleotide polymorphism (SNP), rs7330461. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Personal and Social Performance (PSP) Score | Baseline, Week 6 | Participants (pts) in the EE-ITT population (pts who received at least 1 dose of study drug and were not placebo lead-in responders) who had a baseline and at least 1 post-baseline PSP score. Excluded were pts with missing predefined subpopulation data. Placebo lead-in responders had a ≥25% PANSS total score improvement in the lead-in period. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Personal and Social Performance (PSP) Score in a Predefined Subpopulation | Baseline, Week 6 | EE-ITT participants (see Outcome Measure 1 for population definition) in the predefined subpopulation who had a baseline and at least 1 post-baseline PSP score. The predefined subpopulation excluded non-Hispanic whites (self-reported) who had A/A genotype at the serotonin 2A receptor (HTR2A) single nucleotide polymorphism (SNP), rs7330461. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score in Females | Baseline, Week 6 | Female participants (pts) in EE-ITT population (pts who received at least 1 dose of study drug and were not placebo lead-in responders) who had baseline and at least 1 post-baseline PANSS total score. Excluded were pts with missing predefined subpopulation data. Placebo lead-in responders had ≥25% PANSS total score improvement in lead-in period. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Subscores | Baseline, Week 6 | Participants (pts) in the EE-ITT population (pts who received at least 1 dose of study drug and were not placebo lead-in responders) who had a baseline and at least 1 post-baseline PANSS subscore. Excluded were pts with missing predefined subpopulation data. Placebo lead-in responders had a ≥25% PANSS total score improvement in the lead-in period. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Are Responders | Baseline, Week 6 | Participants in the EE-ITT population (participants who received at least 1 dose of study drug and were not placebo lead-in responders) who had a baseline and at least 1 post-baseline PANSS total score. Placebo lead-in responders had a ≥25% PANSS total score improvement in the lead-in period; Last observation carried forward (LOCF). | percentage of participants | NUMBER |
| SECONDARY | Time to Response | Baseline up to Week 6 | Participants (pts) in the EE-ITT population (pts who received at least 1 dose of study drug and were not placebo lead-in responders) who had a baseline and at least 1 post-baseline PANSS total score. Number of pts censored: 80 mg LY2140023, BID = 88 pts, 40 mg LY2140023, BID = 90 pts, 10 mg LY2140023, BID = 99 pts, and placebo = 189 pts. | days | MEDIAN |
| SECONDARY | Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Scale | Baseline, Week 6 | Participants (pts) in the EE-ITT population (pts who received at least 1 dose of study drug and were not placebo lead-in responders) who had a baseline and at least 1 post-baseline CGI-S score. Excluded were pts with missing predefined subpopulation data. Placebo lead-in responders had a ≥25% PANSS total score improvement in the lead-in period. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the 16-Item Negative Symptoms Assessment (NSA-16) Total Score | Baseline, Week 6 | Participants (pts) in the EE-ITT population (pts who received at least 1 dose of study drug and were not placebo lead-in responders) who had baseline and at least 1 post-baseline NSA-16 total score. Excluded were pts with missing predefined subpopulation data. Placebo lead-in responders had ≥25% PANSS total score improvement in the lead-in period. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline on the European Quality of Life-5 Dimension (EQ-5D) Questionnaire | Baseline, Week 6 | Participants in the EE-ITT population (participants who received at least 1 dose of study drug and were not placebo lead-in responders) who had a baseline and at least 1 post-baseline EQ-5D VAS health state score. Excluded were participants with missing predefined subpopulation data; Last observation carried forward (LOCF). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline on Schizophrenia Resource Utilization Module (S-RUM): Emergency Room (ER) Visits and Outpatient Visits | Baseline and Week (Wk) 6 | Participants (pts) in EE-ITT population (pts who received at least 1 dose of study drug and were not placebo lead-in responders) who had a baseline S-RUM score for ER/facility visits or outpatient visits. Placebo lead-in responders had a ≥25% PANSS total score improvement in the lead-in period; Last observation carried forward (LOCF). | visits | MEAN |
| SECONDARY | Change From Baseline on Schizophrenia Resource Utilization Module (S-RUM): Sessions With a Psychiatrist | Baseline and Week 6 | Participants (pts) in EE-ITT population (pts who received at least 1 dose of study drug and were not placebo lead-in responders) who had a baseline S-RUM score for sessions with a psychiatrist. Placebo lead-in responders had a ≥25% PANSS total score improvement in the lead-in period; Last observation carried forward (LOCF). | sessions | MEAN |
| SECONDARY | Change From Baseline on Subjective Well-Being Under Neuroleptic Treatment Scale - Short Form (SWN-S) Total Score | Baseline, Week 6 | Participants (pts) in the EE-ITT population (pts who received at least 1 dose of study drug and were not placebo lead-in responders) who had a baseline and at least 1 post-baseline SWN-S total score. Excluded were pts with missing predefined subpopulation data. Placebo lead-in responders had ≥25% PANSS total score improvement in the lead-in period. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Barnes Akathisia Scale (BAS) Global Score | Baseline, Week 6 | Participants in the ITT population (participants who received at least 1 dose of study drug according to the treatment group to which they were randomized) who had a baseline and at least 1 post-baseline BAS global score. Excluded were participants with missing predefined subpopulation data. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Simpson-Angus Scale (SAS) Total Score | Baseline, Week 6 | Participants in the ITT population (participants who received at least 1 dose of study drug according to the treatment group to which they were randomized) who had a baseline and at least 1 post-baseline SAS total score. Excluded were participants with missing predefined subpopulation data. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Abnormal Involuntary Movement Scales (AIMS) 1-7 Total Score | Baseline, Week 6 | Participants in the ITT population (participants who received at least 1 dose of study drug according to the treatment group to which they were randomized) who had a baseline and at least 1 post-baseline AIMS 1-7 total score. Excluded were participants with missing predefined subpopulation data. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With a Change From Baseline in Suicidal Behaviors and Ideations Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline up to Week 6 | Participants in the ITT population (participants who received at least 1 dose of study drug according to the treatment group to which they were randomized) who had a baseline and at least 1 post-baseline C-SSRS assessment. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants Who Discontinued | Randomization up to Week 6 | All randomized participants. | participants | NUMBER |
| SECONDARY | Time to Discontinuation | Randomization up to Week 6 | Participants (pts) in the ITT population (pts who received at least 1 dose of study drug according to the treatment group to which they were randomized). Number of pts censored: 80 mg LY2140023, BID = 57 pts, 40 mg LY2140023, BID = 45 pts, 10 mg LY2140023, BID = 60 pts, and placebo = 118 pts. | 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
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GET https://conductscience.org/api/trials/v1/NCT01307800/outcomes