Trial · NCT03107026
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 Number of Binge Days | baseline and 12 Weeks | Change from baseline in number of binge days (defined as days during which at least 1 binge episode occurs) per week at Week 12 |
| Secondary | Change From Baseline in Binge Eating Clinical Global Impression-Severity( BE-CGI-S )Score | baseline and 12 Weeks | Binge-eating Clinical Global Impression-Severity (BE-CGI-S) The BE-CGI-S is a single value, clinician-rated assessment of illness severity, and 7-point scale with range from 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill subjects. A higher score is associated with greater illness severity. |
| Secondary | Percent of Subjects With a 4-week Cessation From Binge Eating | up to 12 Weeks | Percent of subjects with a 4-week cessation from binge eating (defined as a 100% reduction for at least 28 consecutive days in the number of binge eating episodes prior to Week 12/end of treatment \[EOT\]) |
| Secondary | Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score | baseline and 12 Weeks | Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Y-BOCS-BE total scores range from 0 to 40. Y-BOCS-BE obsessions subscale ranges from 0 to 20. Y-BOCS-BE compulsions subscale ranges from 0 to 20. Higher values of Y-BOCS-BE score and subscale scores represent greater severity of illness |
| Secondary | Change From Baseline in Number of Binge Days Per Week at Weeks 1, 2, 3, 4, 6, 8, and 10 | baseline and up to 10 Weeks | Change from baseline in number of binge days per week at Weeks 1, 2, 3, 4, 6, 8, and 10 |
| Secondary | Change From Baseline in Number of Binge Episodes Per Week at Weeks 1, 2, 3, 4, 6, 8, 10, and 12 | baseline and up to 12 Weeks | Change from baseline in number of binge episodes per week at Weeks 1, 2, 3, 4, 6, 8, 10, and 12 |
| Secondary | Change From Baseline in Binge-eating Clinical Global Impression-Severity (BE-CGI-S) Score at Weeks 2, 4, 6, 8, and 10 | baseline and up to 10 Weeks | Binge-eating Clinical Global Impression-Severity (BE-CGI-S) The BE-CGI-S is a single value, clinician-rated assessment of illness severity, and 7-point scale with range from 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill subjects. A higher score is associated with greater illness severity. |
| Secondary | Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Weeks 2, 4, 6, 8, and 10 | baseline and up to 10 Weeks | Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Y-BOCS-BE total scores range from 0 to 40. Y-BOCS-BE obsessions subscale ranges from 0 to 20. Y-BOCS-BE compulsions subscale ranges from 0 to 20. Higher values of Y-BOCS-BE score and subscale scores represent greater severity of illness. |
| Secondary | Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Subscale Scores (Obsessions and Compulsions) at Weeks 2, 4, 6, 8, 10, and 12 | baseline and up to 12 weeks | Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Y-BOCS-BE total scores range from 0 to 40. Y-BOCS-BE obsessions subscale ranges from 0 to 20. Y-BOCS-BE compulsions subscale ranges from 0 to 20. Higher values of Y-BOCS-BE score and subscale scores represent greater severity of illness. |
| Secondary | Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Subscale Scores (School/Work Disability, Social Life Disability, and Family Life Disability) at Weeks 6 and 12 | baseline and 6 Weeks and 12 Weeks | Sheehan Disability Scale (SDS) total and subscale scores The Sheehan Disability Scale (SDS) 3 subscales (work/school, social life, home life) are rated on the following scale: 0 = not at all; 1-3 = mildly; 4-6 = moderately; 7-9 =markedly; 10 = extremely. The 3 items can be combined into a single global measure of impairment (SDS total score) that ranges from 0 (unimpaired) to 30 (highly impaired). A higher subscale score and total score are associated with greater illness severity |
| Secondary | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 12 | baseline and 12 Weeks | Montgomery-Asberg Depression Rating Scale (MADRS) total score The MADRS total score ranges from 0 to 60, with higher scores indicating increased depressive symptoms |
| Secondary | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Week 12 | baseline and 12 Weeks | Hamilton Anxiety Rating Scale (HAM-A) total score HAM-A total score ranges from 0 to 56. A higher score is associated with a greater degree of anxiety. |
| Secondary | Proportion of Binge Eating Responders Who Have ≥ 75% Reduction in the Number of Binge Eating Episodes From Baseline at Week 12 | 12 Weeks | Proportion of binge eating responders who have ≥ 75% reduction in the number of binge eating episodes from Baseline at Week 12 |
| Secondary | Change From Baseline in Eating Disorder Examination Questionnaire (EDE-Q) Modified Including EDE-Q7 Global Score and 3 Subscale Scores (Dietary Restraint, Shape/Weight Overvaluation, and Body Dissatisfaction) at Week 12 | baseline and 2 Weeks | Eating Disorder Examination Questionnaire (EDE-Q) Modified global and subscale scores 4 subscale scores (Restraint, Eating Concern, Shape Concern, and Weight Concern) range from 0- 6, where 0 represents absence of the feature and 6 represents an extreme degree. An EDE-Q global score is calculated as average of 4 EDE-Q subscale scores. |
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
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GET https://conductscience.org/api/trials/v1/NCT03107026/registered