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Trial · NCT02536846

Registered outcomes33

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

ListOutcomeTime frameDescription
OtherChange in Waist Circumferencebaseline and 2, 5, 10 and 15 days (or final assessment) during medication periodChange in waist circumference measurements, taken as an average of 3 measures by tape measure.
OtherChange in Blood Glucose Levelsbaseline and after 15 days during medication periodChange in fasting serum glucose levels.
OtherChange in Fasting Total Cholesterol Levelbaseline and after 15 days medication periodChange in fasting total cholesterol level
OtherChange in Hemoglobin A1c Levelbaseline and after 15 days medication periodChange in fasting, Hemoglobin A1c level
OtherChange in Serum Insulin Levelsbaseline and after 15 days medication periodChange in insulin fasting serum levels
OtherChange in Prolactin Levelsbaseline and after 15 days medication periodChange prolactin serum levels
OtherChange in Total Caloric Intakebaseline and after 15 days medication periodChange in total caloric intake as assessed by the ASA24 Dietary Recall and Food Frequency Questionnaire - Revised. The ASA24 is a self-administered 24-hour dietary recall assessment.
OtherChange in The Wisconsin Schizotypy Scales - Short Form Scoresbaseline and after 15 days medication period
Change in Wisconsin Schizotypy Scales (WSS) Short Form score, a self-report questionnaire assessing schizotypy in clinical and non-clinical samples. The measure has four scales, each with 15 True/False questions. There are 13 red-herring questions, that, if answered "True" invalidate the test. Each "false" response is scored 0, and each "true" response is scored 1. Scores for each scale range from 0 - 15, with higher scores indicating greater schizotypy. The WSS positive schizotypy score consists of the summed score of the perceptual aberration and magical ideation scales and scores range from 0-30, with higher scores indicating greater positive schizotypy. The WSS negative schizotypy score sums scores from the physical anhedonia and social anhedonia scales and ranges from 0-30, with higher scores indicating greater negative schizotypy.
OtherChange in the Early Psychosis Social Scale Survey Scorebaseline and after 15 days medication periodChange in the Early Psychosis Social Scale score item of missed absences from school or work. Scores range from 1-5, with higher scores indicating more absences from school or work.
OtherChange in the Prodromal Questionnaire, Brief Version Total Scorebaseline and after 15 days medication period
Change in the Prodromal Questionnaire, Brief Version score, a 21 item self-report questionnaire designed to help identify those at ultra-high risk for developing psychotic symptoms. The total score is derived as the sum of all 21 items, with a possible range of 0-21. Higher scores indicate greater psychopathology.
OtherChange in the Symptoms Checklist - 90 - Revised Global Severity Scorebaseline and after 15 days medication period
Changes in the Symptoms Checklist - 90 - Revised scale, which measures 9 domains of psychological dysfunction, summing to create an overall psychological distress (Global Severity Score). The scores of each of the 9 domains - somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism - combine for a total of 90 items, each measured on a 5-point scale. The sums of all 90 item scores, ranging 0-360, creates the Global Severity score. Higher scores indicate greater psychopathology.
OtherChange in the State-Trait Anxiety Inventory for Adults Scoresbaseline and after 15 days medication period
Change in the State-Trait Anxiety Inventory for Adults, which measures both state and trait anxiety using 2 subscales for a total of 40 items. Each subscale has a range of 20-80, with higher scores indicating greater state or trait anxiety, respectively.
OtherChange in the World Health Organization Quality of Life Questionnaire Scorebaseline and after 15 days medication period
Change in the World Health Organization Quality of Life questionnaire score, a 26-item assessment of overall quality of life. The questionnaire encompasses 4 domains: physical health, psychological health, social relationships, and environment. There are two additional questions, which assess the participant's perceptions of their own quality of life and physical health. Higher scores indicate better quality of life. Scores are summed within each domain. Total score is obtained by transforming for a total range of 0-100 within each domain.

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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