Trial · NCT03397446
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Enrolment rate | 2 years | Enrolment rate will be defined as the total number of participants enrolled divided by the total enrolment period in months. |
| Primary | Dropout rates | 2 years | Dropout rate will be defined as the number of patients whose participation was terminated prior to completion of the post-treatment assessment divided by the total number of participants enrolled. |
| Primary | The applicability of eligibility criteria | 2 years | The applicability of eligibility criteria will be determined by the ratio of participants screened to participants enrolled. |
| Secondary | Incidence of serious or other treatment-emergent adverse events (TEAEs) | Up to 9 weeks | Subjects will be asked to report TEAEs to the research team and PI. |
| Secondary | Change from baseline in weight/body mass index | Up to 9 weeks | Subjects will be weighed using a calibrated hospital scale while wearing a hospital gown and no footwear. |
| Secondary | Change from baseline in systolic/diastolic blood pressure (mmHg) | Up to 9 weeks | Systolic and diastolic blood pressure will be collected by a study investigator at weekly/biweekly visits. |
| Secondary | Change from baseline in heart rate (bpm) | Up to 9 weeks | Heart rate will be collected by a study investigator at weekly/biweekly visits. |
| Secondary | Incidence of abnormal adherence rates | 2 months | Adherence will be calculated as the number of pills not returned divided by the number of days since the last visit, multiplied by 100 to yield a percentage. Subjects with an adherence rate between 80% and 120% will be considered adherent to treatment. |
| Secondary | Incidence of abnormalities in blood analysis | Up to 9 weeks | Most relevant concerns for patients with BN taking LDX include electrolyte abnormalities (potassium, sodium, chloride) and hypoglycemia |
| Secondary | Incidence of abnormalities in EKG | Up to 9 weeks | Most relevant concerns for patients with BN taking LDX include prolonged QTc, hypertension, and tachycardia. |
| Secondary | Incidence of thoughts, ideations, and attempts of suicide, as measured by the Columbia-Suicide Severity Rating Scale (Since Last Visit Version) | Up to 9 weeks | A clinician-observed measure designed to assess suicidal ideations and suicidal behaviours since the last visit in clinical trials. The scale consists of 4 sections. Section 1 regards suicidal ideation and consists of 5 "yes" or "no" questions. Section 2 regards the intensity of ideation and asks the patient to describe their most severe ideation. In regard to that ideation, the patient then indicates frequency, duration, controllability, deterrents, and reasons for ideation. Section 3 regards suicidal behaviour, and indicates if there has been an actual attempt, interrupted attempt, aborted attempt, or preparatory acts/behaviour since the last visit. Additionally, there is a section to indicate if there was suicidal behaviour during the assessment or if there was a suicide since the last visit. Section 4 specifies information about actual attempts only (actual lethality/medical damage and potential lethality). |
| Secondary | Change from baseline in the number of binge eating episodes per week | Up to 9 weeks | Subjects will record the number of binge eating episodes in a food diary, which will be validated weekly by a clinician using structured questions from the Eating Disorder Examination Interview inquiring about symptom frequency since the previous study visit. |
| Secondary | Change from baseline in the number of purging episodes per week | Up to 9 weeks | Subjects will record the number of self-induced vomiting episodes in a diary which will be validated weekly by a clinician using structured questions from the Eating Disorder Examination Interview inquiring about symptom frequency since the previous study visit. |
| Secondary | Change from baseline in the number of binge eating and purging days per week | Up to 9 weeks | Binge eating and purging days are defined as having one or more episodes of binge eating or purging in a day, respectively. |
| Secondary | Change from baseline in the Eating Disorder Examination Interview scores | Week 1, Post (End of week 8) | A clinician-administered scale that assesses the severity of 4 areas of eating disorder psychopathology over the past 4 weeks (28 days): Eating Concern, Weight Concern, Dietary Restraint, and Shape Concern. Overall eating disorder severity is also assessed. A higher score indicates increased severity. To obtain a particular subscale score, the ratings for the relevant items are added together and the sum divided by the total number of items forming the subscale (i.e., the mean of all subscale items). To obtain a global score, the four subscales scores are summed and the resulting total divided by the number of subscales (i.e., the mean of all items). The scale consists of 28 items. |
| Secondary | Change from baseline in the Barratt Impulsiveness Scale scores | Week 1, Week 5, Post (End of week 8) | This 30-item measure assesses the personality/behavioural construct of impulsiveness and is widely accepted as the primary self-report measure of impulsivity. Items are ranked on a 1-4 scale (1 being "rarely/never" and 4 being "almost always/always"). A total score can be calculated using all 30 items. A higher score indicates higher levels of impulsivity. |
| Secondary | Change from baseline in Yale-Brown Obsessive Compulsive Scale modified for binge eating (Y-BOCS-BE) | Week 1, Week 5, Post (End of week 8) | A 10-item, clinician-administered rating scale for measuring the severity of OCD symptoms as they relate to binge eating. A higher score indicates increased severity. An obsessional subtotal can be calculated by adding items 1-5. A compulsion subtotal can be calculated by adding items 6-10. A total score can be calculated by adding all items. This version will be further modified to assess both binge eating and purging behaviours. |
| Secondary | Change from baseline in the three subscale scores of the Three-Factor Eating Questionnaire (TFEQ) | Week 1, Week 5, Post (End of week 8) | A 51-item self-report scale that assesses three areas of eating behaviours: Cognitive restraint of eating, disinhibition, and hunger. |
| Secondary | Change from baseline in Clinical Impairment Assessment (CIA) scale scores for measuring ED impairment | Week 1, Week 5, Post (End of week 8) | A 16-item self-report measure of the severity of psychosocial impairment due to eating disorder features over the past 28 days. Each item is ranked on a 0-3 scale (0 being "not at all" and 3 being "a lot"). |
| Secondary | Percent of treatment responders (binge and purge response rate) | Through study completion, up to two years | Responders defined as ≥50% reduction in the number of binge and/ or purge episodes from baseline to the last two preceding weeks of treatment. |
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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