Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study evaluates the impact of intranasal oxytocin vs placebo in patients with binge eating disorder or episodes of binging. We hypothesize that 8 weeks of intranasal oxytocin vs placebo will improve clinical outcomes [reduction in bingeing frequency], and have a satisfactory safety and tolerability profile. We will also explore the predictive value of changes in homeostatic appetite, reward sensitivity, and impulse control, the identified underlying mediators, as assessed 4 weeks into the intervention, for treatment success after 8 weeks of the intervention.
Study staff will screen patients for eligibility as per eligibility criteria. At least 60 eligible patients will be randomized 1:1 (active oxytocin: placebo) by an unblinded pharmacist. All other study staff and test subjects will be blinded. Study subject medical histories, physical exams, anthropometric measurements, labs, EKG's, and eating habits will be monitored over 8 weeks. Subjects will be evaluated at the following intervals: Baseline, week 2, week 4, week 8, and week 16 (8 weeks post-treatment).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Arm | Placebo Comparator | Solution without oxytocin |
|
| TNX-1900 | Experimental | Solution with oxytocin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNX-1900 (Tonix Pharmaceuticals) | Drug | oxytocin nasal spray |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Binge Frequency | Change in binge frequency as assessed by the Eating Disorder Examination clinical interview | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reward sensitivity | Predictive value of 4-week change in reward sensitivity per the Temporal Experience of Pleasure Scale (TEPS) Anticipatory Experience of Pleasure subscale score for 8-week change in binge episodes. Higher scores=greater anticipatory pleasuure/less anhedonia. Minimum/Maximum: 10-60 | 8 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren Shabazian, NP | Contact | 617-726-0047 | lshabazian@mgh.harvard.edu | |
| Jordan Hillard | Contact | 617-726-0047 | jhillard1@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth A Lawson, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuroendocrine Unit Research Center | Recruiting | Boston | Massachusetts | 02114 | United States |
Not provided
| ID | Term |
|---|---|
| D056912 | Binge-Eating Disorder |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Study staff and patients are blinded. The pharmacist is unblinded.
| Placebo |
| Drug |
Nasal solution without oxytocin |
|
| Impulse control |
Predictive value of 4 week change in impulse control per Stop-Signal Reaction time in a Stop-Signal Task for 8 week change in binge frequency |
| 8 weeks |
| D013568 | Pathological Conditions, Signs and Symptoms |