ConductScience.org, home

Trial · NCT01291173

Registered outcomes14

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

ListOutcomeTime frameDescription
PrimaryChange From Baseline in Log Transformed Binge Days Per Week at Week 11Baseline and week 11Binge day is defined as a day during which at least 1 binge episode occurs.
SecondaryChange From Baseline in the Number of Binge Episodes Per Week at Up to 11 WeeksBaseline and up to 11 weeksThe number of binge episodes per week as assessed by clinical interview based on subject diary.
Secondary1-Week Binge Response, Last Observation Carried Forward (LOCF)Last 7 days on study
The 1-week binge response was defined as either a 1-week remission (a 100% reduction of binge episodes from baseline \[ie, a cessation of binge eating behavior\]), or a marked response (75 to \<100% reduction in binge episodes from baseline), or a moderate response (50 to \<75% reduction in binge episodes from baseline), or a negative/minimal response (\<50% reduction in binge episodes from baseline). The 1-week response was determined at the end of the study utilizing a LOCF approach.
Secondary4-Week Binge ResponseLast 28 days on studySubjects are free from binge episodes for 4 weeks.
SecondaryPercent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at BaselineBaselineCGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
SecondaryPercent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeksup to 11 weeksCGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
SecondaryPercentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Up to 11 WeeksUp to 11 weeks
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
SecondaryChange From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score at Week 11Baseline and week 11
The YBOCS-BE measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). Total scores range from 0 to 40. A score of 0-7 is sub-clinical; 8-15 is mild; 16-23 is moderate; 24-31 is severe; and 32-40 is extreme.
SecondaryChange From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Score at Week 11Baseline and week 11MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.
SecondaryChange From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Week 11Baseline and week 11
The HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe) with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe, and 31-56 severe anxiety.
SecondaryChange From Baseline in Eating Inventory Score at Week 11Baseline and week 11
The Eating Inventory also known as the Three-Factor Eating Questionnaire is a 51-item self-reported questionnaire intended to assess 3 dimensions of eating behavior: cognitive restraint of eating, disinhibition, and hunger. Cognitive restraint of eating consists of 20 items, disinhibition consists of 16 items, and hunger consists of 15 items. Each item scores either 0 or 1 point for a total score of 0-20 for cognitive restraint of eating, 0-16 for disinhibition, and 0-15 for hunger. A higher score is better for cognitive restraint of eating and lower scores are better for disinhibition and hunger.
SecondaryChange From Baseline in Binge Eating Scale (BES) Score at Week 11Baseline and week 11
The BES is a 16-item self-reported questionnaire that is designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. The items are summed, with possible scores ranging from 0 to 46. A score of 27 or higher indicates severe binge-eating problems, and a score of 17 or lower designates no binge-eating problems.
SecondaryChange From Baseline in Barratt Impulsiveness Scale (BIS-11) Total Score at Week 11Baseline and week 11
The BIS-11 is a self-reported 30-item questionnaire that measures impulsiveness using a 4-point Likert scale (rarely/never = 1, occasionally = 2, often = 3, almost always/always = 4). A Total Impulsivity score is calculated by summing the scores for each item. Possible scores range from 30 - 120. Higher scores indicate increased impulsiveness.
SecondaryChange From Baseline in Short Form-12 Health Survey (SF-12) Score at Week 11Baseline and week 11
The SF-12 is a 12-item self-report questionnaire that is a subset of the SF-36 Health Survey. The survey captures physical and mental health. There are 8 subscales. Four of the subscales has one-item each; the other 4 have two-items each. For each subscale, a mean value was first computed and transformed to a position on a scale ranging from 0-100 (Z-transformation). The aggregate total scores are then transformed into a mean value ranging from 0 (lowest level of health) to 100 (highest level of health).

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.

Twenty rows a page, as JSON. No key.

GET https://conductscience.org/api/trials/v1/NCT01291173/registered