Solriamfetol in Binge Eating Disorder

NCT04602936 | Unknown Phase 4

• 1 other identifier: Jazz BED
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this project is to evaluate the efficacy and tolerability of the novel dopamine and norepinephrine reuptake inhibitor (DNRI) solriamfetol in the treatment of binge eating disorder (BED).

Conditions

Binge Eating Disorder

Outcome Measures

Primary Outcomes (1)

• The primary efficacy variable is binge-eating day frequency as assessed by the take-home patient diary.

  days with binge eating episodes

  Days 1-84

Secondary Outcomes (3)

• The secondary efficacy variables will include binge-eating episode frequency.

  Days 1-84

• The score on the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOC-BE).

  Weeks 1, 2, 3, 4, 6, 8, 10, 12

• The score on the Clinical Global Impression-Severity (CGI-S) and Clinical Global Impressions-Improvement scale (CGI-I).

  Weeks 1, 2, 3, 4, 6, 8, 10, 12

Study Arms (2)

Solriamfetol

ACTIVE COMPARATOR

All medication will be 37.5 mg encapsulated soriamfetol tablets or matching encapsulated placebo tablets supplied in numbered containers for dispensing to patients. The minimum dose of solriamfetol during the trial will be 37.5 mg/day; the maximum dose will be 150 mg/day. At the Baseline Visit (Visit 0), participants will be instructed to take one capsule of solriamfetol 37.5 mg or matching placebo in the morning for the first 7 days. Thereafter, at Visit 1, solriamfetol or placebo will be increased to 75 mg/day, if tolerated. Beginning on day 15 (Visit 2), solriamfetol or placebo will be increased to 150 mg/day, if tolerated. Study medication dosage may be decreased, or a scheduled increase may not be made, because of side effects. Study medication will be administered as a single daily dose in the morning.

Drug: Solriamfetol

Placebo

PLACEBO COMPARATOR

Placebo (i.e., inactive compound for comparison)

Drug: Placebo

Interventions

Solriamfetol DRUG

Solriamfetol is a novel DNRI (novel dopamine and norepinephrine reuptake inhibitor) that has recently received regulatory approval for the treatment of excessive daytime sleepiness in individuals with narcolepsy or obstructive sleep apnea.

Also known as: Sunosi

Solriamfetol

Placebo DRUG

A placebo is a substance or treatment which is designed to have no therapeutic value (an inactive compound, i.e. inert, often called a "sugar pill").

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will meet DSM-5 criteria for a diagnosis of BED. These criteria are:
• Recurrent episodes of binge eating. Both of the following characterize a binge-eating episode: 1. Eating, in a discrete period (e.g., within 2 hours), an amount of food that is definitely larger than most people would eat in a similar period under similar conditions; and 2. A sense of lack of control over the eating (e.g., a feeling that one cannot stop eating or control what or how much one is eating).
• The binge-eating episodes are associated with at least three of the following: eating much more rapidly than normal; eating until uncomfortably full; eating large amounts of food when not feeling physically hungry; eating alone because of being embarrassed by how much one is eating; feeling disgusted with oneself, depressed, or feeling very guilty after overeating.
• Marked distress regarding binge eating.
• The binge eating occurs, on average, at least one day a week for 3 months.
• The episodes of binge eating do not occur exclusively during the course of bulimia nervosa or anorexia nervosa.
• In addition, to ensure that BED is of at least moderate severity, participants will report at least three binge-eating days per week during the 1 week prior to initiation of study medication, prospectively documented in take-home binge diaries. A binge-eating day (or binge day) is a day during which at least one binge-eating episode occurs.
• Men or women, through the ages of 18 and 65 years, inclusive.

You may not qualify if:

• Have a current diagnosis of bulimia nervosa or anorexia nervosa.
• Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures. The following are considered adequate methods of birth control: 1. intrauterine device (IUD); 2. barrier protection; 3. a contraceptive implantation system (Norplant); 4. oral contraceptive pills; 5. a surgically sterile patient; and 6. abstinence. All female participants will have a negative pregnancy test prior to randomization.
• Individuals who are displaying clinically significant suicidality or homicidality.
• Individuals who are receiving a psychological (e.g., supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) or weight loss (e.g., Weight Watchers) intervention for BED that was begun within the 3 months before study entry. Individuals beginning such treatment more than 3 months prior to study entry may be enrolled as long as they to agree to not make any changes to the frequency or nature of their treatment during the course of the drug trial.
• A DSM-IV-TR diagnosis of substance abuse or dependence (except nicotine abuse or dependence) within the 6 months prior to randomization.
• Individuals who have used psychostimulants to facilitate fasting or dieting as a part of their eating disorder within the past 6 months, individuals who have misused psychostimulants within the past 6 months, and individuals who have a drug screen at the Screening visit positive for psychostimulants.
• Individuals with a lifetime DSM-IV-TR history of psychosis, mania or hypomania, or dementia.
• Individuals with a history of any psychiatric disorder that might interfere with a diagnostic assessment, treatment, or study compliance.
• Individuals who have a body mass index (BMI) ≤ 18 mg/kg2
• Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine, or other systemic disease.
• Have a history of a structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormality, coronary artery disease, stroke, or other serious cardiovascular problem.
• History of seizures, including clinically febrile seizures in childhood.
• Have uncontrolled hypertension (\>160/100) or tachycardia (heart rate \>110).
• Have an ECG with significant arrhythmias or conduction abnormalities, which in the opinion of the physician investigator precludes study participation.
• Have clinically relevant abnormal laboratory results, specifically including hypokalemia.

Sponsors & Collaborators

• Lindner Center of HOPE: lead
• Jazz Pharmaceuticals: collaborator

Study Sites (1)

Lindner Center of HOPE

Mason, Ohio, 45040, United States

RECRUITING

Related Publications (1)

• Guerdjikova AI, Romo-Nava F, Blom TJ, Mori N, McElroy SL. Study protocol and rationale for a randomized, placebo-controlled trial of solriamfetol to treat binge eating disorder. Contemp Clin Trials. 2021 Nov;110:106587. doi: 10.1016/j.cct.2021.106587. Epub 2021 Oct 2.

  PMID: 34610482 DERIVED

MeSH Terms

Conditions

Binge-Eating Disorder

Interventions

solriamfetol

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Central Study Contacts

Anna Guerdjikova

CONTACT

513-536-0700; anna.guerdjikova@lindnercenter.org

Genie Groff

CONTACT

513-536-0700; genie.groff@lindnercenter.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind, placebo-controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a 1-site, randomized, parallel group, double-blind, placebo-controlled, flexible-dose study in which solriamfetol 37.5-150 mg/day will be administered for 12 weeks to 64 outpatient adults with BED by DSM-5 criteria

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 26, 2020
• Study Start: June 15, 2021
• Primary Completion: August 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 8, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)