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Solriamfetol in Binge Eating Disorder

Primary Purpose

Binge Eating Disorder

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Solriamfetol
Placebo
Sponsored by
Lindner Center of HOPE
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge Eating Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Criteria for entering this study will include all of the following:

  1. Participants will meet DSM-5 criteria for a diagnosis of BED. These criteria are:

    1. 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).
    2. 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.
    3. Marked distress regarding binge eating.
    4. The binge eating occurs, on average, at least one day a week for 3 months.
    5. The episodes of binge eating do not occur exclusively during the course of bulimia nervosa or anorexia nervosa.
  2. 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.
  3. Men or women, through the ages of 18 and 65 years, inclusive.

Exclusion Criteria: Criteria for exclusion from this study will be any of the following:

  1. Have a current diagnosis of bulimia nervosa or anorexia nervosa.
  2. 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.
  3. Individuals who are displaying clinically significant suicidality or homicidality.
  4. 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.
  5. A DSM-IV-TR diagnosis of substance abuse or dependence (except nicotine abuse or dependence) within the 6 months prior to randomization.
  6. 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.
  7. Individuals with a lifetime DSM-IV-TR history of psychosis, mania or hypomania, or dementia.
  8. Individuals with a history of any psychiatric disorder that might interfere with a diagnostic assessment, treatment, or study compliance.
  9. Individuals who have a body mass index (BMI) ≤ 18 mg/kg2
  10. Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine, or other systemic disease.
  11. Have a history of a structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormality, coronary artery disease, stroke, or other serious cardiovascular problem.
  12. History of seizures, including clinically febrile seizures in childhood.
  13. Have uncontrolled hypertension (>160/100) or tachycardia (heart rate >110).
  14. Have an ECG with significant arrhythmias or conduction abnormalities, which in the opinion of the physician investigator precludes study participation.
  15. Have clinically relevant abnormal laboratory results, specifically including hypokalemia.
  16. Have a history of narcolepsy or obstructive sleep apnea, or currently receiving treatment with an alerting agent.
  17. Individuals requiring treatment with any drug which might interact adversely with or obscure the action of the study medication. This includes warfarin, anticonvulsants, clonidine, theophylline, and pseudoephedrine.
  18. Individuals who have received any psychotropic medications (other than hypnotics) within four weeks prior to randomization, including antidepressants (including monoamine oxidase inhibitors), antipsychotics, mood stabilizers, or psychostimulants.
  19. Individuals who have received investigational medications or depot neuroleptics within three months prior to randomization.
  20. Individuals who have a known allergy to solriamfetol or its constituents.

Sites / Locations

  • Lindner Center of HOPERecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Solriamfetol

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The secondary efficacy variables will include binge-eating episode frequency.
Number of binge eating episodes per week
The score on the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOC-BE).
Questions on scale range from 0-4, higher scores are worse. There are 10 questions total. The first 5 questions consist of the "obsessional sub-total" (scores are added together). Questions 6-10 are added together and equal the "compulsion sub-total."
The score on the Clinical Global Impression-Severity (CGI-S) and Clinical Global Impressions-Improvement scale (CGI-I).
The Clinical Global Impression - Severity and Improvement scale (CGI-S, CGI-I) is a 7-point scale that requires the clinician to rate the severity and improvement of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. On the CGI-S question, scores range from 1-7, with higher scores being worse (1 = normal, 7 = very severely ill). On the CGI-I questions, scores range from 1-8, with higher scores being worse (1 = no change, 7 = very much worse, 8 = not applicable).

Full Information

First Posted
October 14, 2020
Last Updated
March 7, 2023
Sponsor
Lindner Center of HOPE
Collaborators
Jazz Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04602936
Brief Title
Solriamfetol in Binge Eating Disorder
Official Title
Solriamfetol in Binge Eating Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lindner Center of HOPE
Collaborators
Jazz Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
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. The study will have 3 phases: a 1-2 week Screening phase to evaluate participant eligibility; a 12-week blinded Treatment phase during which participants will receive solriamfetol or matching placebo; and a 1-week Treatment Discontinuation phase. During the Treatment phase, participants will be evaluated weekly for the first 4 weeks and then biweekly for the next 8 weeks. Solriamfetol will be started at 37.5 mg/day. After 1 week, study drug will be increased to 75 mg/day. If a participant continues to have BED symptoms, study drug may be increased to a maximum of 150 mg/d by Treatment week 6; after that, study drug dose will be held constant. Efficacy will be assessed by measuring the weekly frequency of binge-eating episode days with patient take-home diaries. Regular monitoring of vital signs, laboratory tests, electrocardiograms (ECGs), adverse events, and suicidality will assess safety

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double-blind, placebo-controlled
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Solriamfetol
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (i.e., inactive compound for comparison)
Intervention Type
Drug
Intervention Name(s)
Solriamfetol
Other Intervention Name(s)
Sunosi
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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").
Primary Outcome Measure Information:
Title
The primary efficacy variable is binge-eating day frequency as assessed by the take-home patient diary.
Description
days with binge eating episodes
Time Frame
Days 1-84
Secondary Outcome Measure Information:
Title
The secondary efficacy variables will include binge-eating episode frequency.
Description
Number of binge eating episodes per week
Time Frame
Days 1-84
Title
The score on the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOC-BE).
Description
Questions on scale range from 0-4, higher scores are worse. There are 10 questions total. The first 5 questions consist of the "obsessional sub-total" (scores are added together). Questions 6-10 are added together and equal the "compulsion sub-total."
Time Frame
Weeks 1, 2, 3, 4, 6, 8, 10, 12
Title
The score on the Clinical Global Impression-Severity (CGI-S) and Clinical Global Impressions-Improvement scale (CGI-I).
Description
The Clinical Global Impression - Severity and Improvement scale (CGI-S, CGI-I) is a 7-point scale that requires the clinician to rate the severity and improvement of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. On the CGI-S question, scores range from 1-7, with higher scores being worse (1 = normal, 7 = very severely ill). On the CGI-I questions, scores range from 1-8, with higher scores being worse (1 = no change, 7 = very much worse, 8 = not applicable).
Time Frame
Weeks 1, 2, 3, 4, 6, 8, 10, 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Criteria for entering this study will include all of the following: 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. Exclusion Criteria: Criteria for exclusion from this study will be any of the following: 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. Have a history of narcolepsy or obstructive sleep apnea, or currently receiving treatment with an alerting agent. Individuals requiring treatment with any drug which might interact adversely with or obscure the action of the study medication. This includes warfarin, anticonvulsants, clonidine, theophylline, and pseudoephedrine. Individuals who have received any psychotropic medications (other than hypnotics) within four weeks prior to randomization, including antidepressants (including monoamine oxidase inhibitors), antipsychotics, mood stabilizers, or psychostimulants. Individuals who have received investigational medications or depot neuroleptics within three months prior to randomization. Individuals who have a known allergy to solriamfetol or its constituents.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Guerdjikova
Phone
513-536-0700
Email
anna.guerdjikova@lindnercenter.org
First Name & Middle Initial & Last Name or Official Title & Degree
Genie Groff
Phone
513-536-0700
Email
genie.groff@lindnercenter.org
Facility Information:
Facility Name
Lindner Center of HOPE
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Guerdjikova, phD
Phone
513-536-0700

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34610482
Citation
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.
Results Reference
derived

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Solriamfetol in Binge Eating Disorder

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