Trial · NCT01291173
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Log Transformed Binge Days Per Week at Week 11 | Baseline and week 11 | Binge day is defined as a day during which at least 1 binge episode occurs. |
| Secondary | Change From Baseline in the Number of Binge Episodes Per Week at Up to 11 Weeks | Baseline and up to 11 weeks | The number of binge episodes per week as assessed by clinical interview based on subject diary. |
| Secondary | 1-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. |
| Secondary | 4-Week Binge Response | Last 28 days on study | Subjects are free from binge episodes for 4 weeks. |
| Secondary | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline | Baseline | CGI-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) |
| Secondary | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks | up to 11 weeks | CGI-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) |
| Secondary | Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Up to 11 Weeks | Up 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. |
| Secondary | Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score at Week 11 | Baseline 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. |
| Secondary | Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Score at Week 11 | Baseline and week 11 | MADRS 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. |
| Secondary | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Week 11 | Baseline 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. |
| Secondary | Change From Baseline in Eating Inventory Score at Week 11 | Baseline 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. |
| Secondary | Change From Baseline in Binge Eating Scale (BES) Score at Week 11 | Baseline 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. |
| Secondary | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) Total Score at Week 11 | Baseline 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. |
| Secondary | Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Week 11 | Baseline 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.
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