Solriamfetol for Binge Eating Disorder
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop taking any psychotropic medications (medications affecting mood, perception, or behavior) at least four weeks before starting the study. This includes antidepressants, antipsychotics, mood stabilizers, and psychostimulants. If you are on any medications that might interact with the study drug, like warfarin or anticonvulsants, you may also need to stop those.
What data supports the effectiveness of the drug Solriamfetol for treating binge eating disorder?
Solriamfetol is being studied for its effectiveness in treating binge eating disorder (BED) because it is a dopamine and norepinephrine reuptake inhibitor (DNRI), which may help reduce binge eating episodes. While direct evidence for solriamfetol in BED is still being evaluated, similar drugs like armodafinil have shown some promise in reducing binge eating episodes and related symptoms.12345
How is the drug Solriamfetol unique for treating Binge Eating Disorder?
Solriamfetol is unique for treating Binge Eating Disorder because it is primarily known for its use in treating sleep disorders like narcolepsy and obstructive sleep apnea, where it works by increasing wakefulness. This mechanism of action, which involves stimulating certain brain pathways, may offer a novel approach compared to traditional treatments for Binge Eating Disorder.678910
What is the purpose of this trial?
This trial tests solriamfetol, a medication that balances brain chemicals, in adults with Binge Eating Disorder (BED) to see if it can reduce their binge eating episodes.
Eligibility Criteria
This trial is for adults aged 18-65 with Binge Eating Disorder (BED), experiencing significant distress and at least three binge-eating days per week. They must meet DSM-5 criteria for BED without a history of bulimia or anorexia nervosa. Excluded are pregnant individuals, those with recent substance abuse, serious psychiatric or medical conditions, uncontrolled hypertension or heart issues, misuse of stimulants, and anyone on certain medications.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive solriamfetol or placebo for 12 weeks, with weekly evaluations for the first 4 weeks and biweekly evaluations for the next 8 weeks
Treatment Discontinuation
Participants discontinue treatment and are monitored for any withdrawal effects
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Solriamfetol
Solriamfetol is already approved in United States for the following indications:
- Excessive daytime sleepiness in patients with narcolepsy
- Excessive daytime sleepiness in patients with obstructive sleep apnea
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lindner Center of HOPE
Lead Sponsor
Jazz Pharmaceuticals
Industry Sponsor
Bruce C. Cozadd
Jazz Pharmaceuticals
Chief Executive Officer since 2009
BA in Economics from Yale University, MBA from Stanford University
Dr. Austin
Jazz Pharmaceuticals
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland