Registered outcomes20

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

1 to 20 of 20

List	Outcome	Time frame	Description
Primary	Change From Baseline in the Number of Binge Days Per Week at Visit 8 Which Spans Weeks 11/12	Baseline and Visit 8 Which Spans Weeks 11/12	Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on subject binge diary.
Secondary	Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores	Up to 12 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	Percent of Participants With a 4-Week Cessation From Binge Eating	Up to 12 weeks	4-week cessation from binge eating is defined as no binge eating episodes for 28 consecutive days prior to the last study visit.
Secondary	Percent Change From Baseline in Body Weight (kg) at Week 12	Baseline and week 12
Secondary	Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12	Baseline and week 12	The Y-BOCS-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. Reduction in total score indicates improvement.
Secondary	Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks	Baseline and up to 12 weeks
Secondary	Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks	Baseline and up to 12 weeks
Secondary	Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks	Baseline and up to 12 weeks
Secondary	Binge Eating Response	Up to 12 weeks	Response is based on the reduction in the number of binge eating episodes. Responses were categorized as follows: -1-week Cessation = 100% reduction in binge episodes during the preceding 7 days -Marked Reduction = 99% to 75% reduction during the time since the previous visit -Moderate Reduction = 74% to 50% reduction during the time since the previous visit -Negative to Minimal Reduction = \<50% reduction during the time since the previous visit
Secondary	Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12	Baseline and Visit 8 Which Spans Weeks 11/12
Secondary	Change From Baseline in Eating Inventory Scores at Week 12	Baseline and week 12	There are 36 true/false items, 14 items on a 4-point Likert scale (1=eat rarely to 4=always), and 1 item on a 6-point Likert scale (1=eat whatever you want to 6=constantly limiting food intake). Cognitive Restraint score ranges from 0-21. Hunger score ranges from 0-14. Disinhibition score ranges from 0-16. Higher scores denote higher levels of restrained eating, disinhibited eating and predisposition to hunger.
Secondary	Change From Baseline in Binge Eating Scale (BES) Score at Week 12	Baseline and week 12	The BES is a self-reported questionnaire containing 16 items designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. Each item is assessed based on 1 of 4 responses, with 1 denoting that a subject has greater control over eating behavior and 4 denoting that a subject had less control over eating behavior. A total score (sum of the 16 items) may range from 16-64. A lower score indicates greater control over eating behavior.
Secondary	Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Up to 12 Weeks	Baseline and up to 12 weeks	The FrSBe is a 46-item self-rating scale designed to measure the neurobehavioral traits associated with the 3 primary regions of the prefrontal cortex. Subjects were asked to indicate the frequency with which they have engaged in certain behaviors using a rating scale from "1" (almost never) to "5" (almost always). Summary scores were calculated and converted to t-score. A decrease from baseline in FrSBe total score represents improvement.
Secondary	EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility	Up to 12 weeks	Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Secondary	EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care	Up to 12 weeks
Secondary	EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities	Up to 12 weeks
Secondary	EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort	Up to 12 weeks
Secondary	EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression	Up to 12 weeks
Secondary	Columbia-Suicide Severity Rating Scale (C-SSRS)	Up to 12 weeks	C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.
Secondary	Change in Amphetamine Cessation Symptom Assessment (ACSA) Total Score From Baseline to Week 12.	Baseline and Week 12	ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity. Calculated as Baseline (Day 0) - Week 12 ACSA 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.

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