What side effects are associated with this type of intervention?

Common treatments for Binge Eating Disorder (BED), particularly Dopamine and Norepinephrine Reuptake Inhibitors (DNRIs) like Solriamfetol, can cause side effects such as insomnia, dry mouth, headache, increased heart rate, and anxiety. Other treatments, such as SSRIs, may result in nausea, fatigue, and sexual dysfunction. Stimulants like methylphenidate, used off-label, can lead to insomnia, increased blood pressure, and potential for abuse.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Binge Eating Disorder (BED). One notable approval is for lisdexamfetamine dimesylate, a stimulant that affects dopamine and norepinephrine levels, similar to Solriamfetol. Lisdexamfetamine is specifically indicated for moderate to severe BED. Other treatments for BED may include off-label use of medications such as selective serotonin reuptake inhibitors (SSRIs) and other stimulant medications, but these are not specifically approved by the FDA for BED.

What other types of research exist?

Promising novel alternatives to Solriamfetol for Binge Eating Disorder patients include olanzapine, which has been studied for its antiemetic properties and may have potential in managing BED due to its effects on appetite and weight. Additionally, other dopamine and norepinephrine reuptake inhibitors or agents like bupropion, which has shown efficacy in ADHD, could be considered for their potential benefits in BED.

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Dopamine and Norepinephrine Reuptake Inhibitor

Solriamfetol for Binge Eating Disorder

Phase 4

Recruiting

Research Sponsored by Lindner Center of HOPE

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men or women, aged 18 to 65 years inclusive.

Be older than 18 years old

Must not have

Received any psychotropic medications (other than hypnotics) within four weeks prior to randomization.

Pregnant, lactating, or of childbearing potential without adequate contraceptive measures.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 1, 2, 3, 4, 6, 8, 10, 12

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

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.

Who is the study for?

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.

What is being tested?

The study tests the effectiveness and safety of solriamfetol—a drug affecting dopamine and norepinephrine—in treating BED against a placebo. Participants will be randomly assigned to receive either solriamfetol or a placebo to compare outcomes.

What are the potential side effects?

Solriamfetol may cause side effects such as trouble sleeping, headaches, dry mouth, nausea, decreased appetite, anxiety and increased heart rate. The severity can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not taken any psychotropic drugs, except for sleep aids, in the last 4 weeks.

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I am not pregnant, breastfeeding, or if capable of becoming pregnant, I am using effective birth control.

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I have a serious heart condition or have had a stroke.

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I have had seizures in the past, including as a child.

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I have narcolepsy or sleep apnea, or I'm taking medication to stay awake.

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My blood pressure is not higher than 160/100 and my heart rate is not over 110.

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I do not have any unstable health conditions affecting my heart, liver, kidneys, stomach, lungs, or hormones.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 1, 2, 3, 4, 6, 8, 10, 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 1, 2, 3, 4, 6, 8, 10, 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1, 2, 3, 4, 6, 8, 10, 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

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

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: SolriamfetolActive Control1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Dopamine and norepinephrine reuptake inhibitors (DNRIs) like solriamfetol work by increasing the levels of dopamine and norepinephrine in the brain, which are crucial for regulating mood, attention, and reward pathways. This mechanism is particularly important for Binge Eating Disorder (BED) patients, as dysregulation in these neurotransmitter systems can lead to compulsive eating behaviors and a lack of control. By enhancing the activity of these neurotransmitters, DNRIs can help reduce binge eating episodes, improve mood, and support healthier eating behaviors.

[Addiction to cocaine and other stimulants].Psychiatric disorders in Prader-Willi syndrome: epidemiology and management.Methylphenidate treatment for bulimia nervosa associated with a cluster B personality disorder.