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Trial · NCT01129674

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryTime to discontinuation due to adverse eventsBaseline through 52 weeks
SecondaryChange from baseline to 52 weeks endpoint in PANSS (Positive and Negative Syndrome Scale)Baseline, 52 weeks
SecondaryChange from baseline to 52 week endpoint in Clinical Global Impression-Severity (CGI-S)Baseline, 52 weeks
SecondaryChange from baseline to 52 week endpoint in NSA-16 (16-item Negative Symptoms Assessment)Baseline, 52 weeks
SecondaryThe number of patients with statistically significant changes (treatment emergent ideation and behavior; improvement) based on the Columbia Suicide Severity Rating Scale (C-SSRS)52 weeks, 104 weeks, end of study
SecondaryChange from baseline to 52 week endpoint in PSP scale (Personal and Social Performance)Baseline, 52 weeks
SecondaryChange from baseline to 52 week endpoint in the SWN Scale (Subjective Well-Being Under Neuroleptic Treatment)Baseline, 52 weeks
SecondaryChange from baseline to 104 week endpoint in the Schizophrenia Resource Use Model (S-RUM)Baseline, 104 weeks
SecondaryChange from baseline to 104 week endpoint in the EuroQoL Questionnaire-5 Dimension (EQ-5D)Baseline, 104 weeks
SecondaryChange from 52 week to 104 week endpoint in PANSS (Positive and Negative Syndrome Scale)52 weeks, 104 weeks
SecondaryChange from 52 week to 104 week endpoint in Clinical Global Impression-Severity (CGI-S)52 weeks, 104 weeks
SecondaryChange from 52 week to 104 week endpoint in NSA-16 (16-item Negative Symptoms Assessment)52 weeks, 104 weeks
SecondaryChange from 104 week to study endpoint in Clinical Global Impression-Severity (CGI-S)104 weeks, end of study
SecondaryChange from baseline to 104 week endpoint in PSP scale (Personal and Social Performance)Baseline, 104 weeks
SecondaryChange from baseline to 104 week endpoint in the SWN Scale (Subjective Well-Being Under Neuroleptic Treatment)Baseline, 104 weeks
SecondaryChange from Baseline to 52 week endpoint in the Schizophrenia Resource Use Model (S-RUM)Baseline, 52 weeks
SecondaryChange from 104 week to study endpoint in the EuroQoL Questionnaire-5 Dimension (EQ-5D)104 weeks, end of study
SecondaryChange from baseline to 52 weeks endpoint in PANSS (Positive and Negative Syndrome Scale) in a genetically defined subgroupBaseline, 52 Weeks

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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