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Trial · NCT01617187

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Baseline in PANSS Total Score at Day 42Baseline and Day 42FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Scorescore on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in CGI-S Score at Day 42Baseline and Day 42FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Scorescore on a scaleLEAST_SQUARES_MEAN
SECONDARYPercentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42Baseline and Day 42FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Scorepercentage of participantsNUMBER
SECONDARYChange From Baseline in Body Weight at Day 42Baseline and Day 42All randomized participants who received ≥1 dose of study drugkgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35Baseline and Days 4, 7, 14, 21, 28 and 35FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Scorescore on a scaleLEAST_SQUARES_MEAN
SECONDARYPercentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35Days 4, 7, 14, 21, 28 and 35FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Scorepercentage of participantsNUMBER
SECONDARYChange From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35Baseline and Days 4, 7, 14, 21, 28 and 35FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Scorescore on a scaleLEAST_SQUARES_MEAN
SECONDARYPercentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42Days 4, 7, 14, 21, 28, 35 and 42FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Scorepercentage of participantsNUMBER
SECONDARYChange From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42Baseline and Days 4, 7, 14, 21, 28, 35 and 42FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Scorescore on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42Baseline and Days 4, 7, 14, 21, 28, 35 and 42FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Scorescore on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42Baseline and Days 4, 7, 14, 21, 28, 35 and 42FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Scorescore on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42Baseline and Days 4, 7, 14, 21, 28, 35 and 42FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Scorescore on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42Baseline and Days 4, 7, 14, 21, 28, 35 and 42FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Scorescore on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42Baseline and Days 4, 7, 14, 21, 28, 35 and 42FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Scorescore on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42Baseline and Days 4, 7, 14, 21, 28, 35 and 42FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Scorescore on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42Baseline and Days 4, 7, 14, 21, 28, 35 and 42FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Scorescore on a scaleLEAST_SQUARES_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.

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