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Combination Therapy for Binge Eating Disorder
Study Summary
This trial will compare the effectiveness of cognitive behavioral therapy, lisdexamfetamine, and a combination of the two for treating binge-eating disorder in obese patients.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am currently taking Vyvanse, Wellbutrin, Zyban, Naltrexone, or Contrave.I am between 18 and 64 years old.You have been diagnosed with binge-eating disorder according to the DSM-5 guidelines.I have a condition affecting my gallbladder.I have had issues with LDX or similar medications before.My BMI is between 27 and 50, and if it's under 30, I have a related health condition under control.I am currently taking opioid pain medications.I am not taking any medications that would interfere with the study drugs.My heart health is cleared by an EKG and doctor's review.I am not pregnant, breastfeeding, and I agree to use contraception.You have a serious mental illness that requires you to stay in the hospital or receive intensive treatment.My high blood pressure is not under control.I have a history of serious heart conditions or high blood pressure.You have a history of an eating disorder like anorexia or bulimia, or you currently make yourself vomit on a regular basis.I can travel to New Haven, CT for weekly visits.My diabetes is not currently under control.I am currently taking medication for depression or other conditions that affects my brain chemistry.I am prone to having seizures.My thyroid condition is not under control.I am currently using medication for ADHD or psychostimulants.You currently have thoughts of hurting yourself or others and have a plan or intention to do so.You have a history of or currently struggle with alcohol or drug addiction.I am allergic to the study medication or similar stimulants.I am currently on a proven treatment plan for eating or weight loss issues.I do not have severe kidney, liver, nerve, lung diseases or other serious health issues.
- Group 1: LDX
- Group 2: Cognitive-Behavioral Therapy
- Group 3: LDX and Cognitive Behavioral Therapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does the literature on LDX suggest potential benefits for patients?
"Out of the 6 ongoing clinical trials for LDX, 3 are in Phase 3. The trial sites are primarily based in Iowa City, Iowa, but 6 different locations are running these studies."
Has the FDA given the green light to LDX?
"LDX has received a score of 3 from our team at Power. This is due to the fact that this is a Phase 3 trial, which provides some data supporting efficacy as well as multiple rounds of data supporting safety."
Does this research project include any adults over the age of 45?
"Those who meet the age criteria of 18-64 and meet the other inclusion requirements may take part in this trial. Out of the 902 similar clinical trials, this one is middle-of-the-pack in terms of age restrictions."
To whom is this trial available?
"This trial is recruiting 180 participants that currently suffer from binge-eating disorder. The ideal candidate is between 18-64 years old, able to travel to New Haven, CT for weekly visits, has a BMI of 27-30 and meets the DSM-5 criteria for binge-eating disorder. Additionally, they must be cleared by EKG and medical record review, available for the duration of the treatment and follow-up (18 months), and be able to read, comprehend, and write English at a sufficient level to complete study-related materials."
Are new participants being sought for this trial?
"That is correct. The aforementioned website provides information which suggests that this study is looking for individuals to participate. The trial was first posted on 2019-03-25 and was last edited on 2022-01-06. The clinical trial is recruiting for 180 patients between 1 sites."
How many test subjects are a part of this experiment?
"Yes, this is an active recruitment trial according to the latest update on clinicaltrials.gov. The study is looking for a total of 180 participants across 1 location."
What makes this clinical trial unique?
"There are presently 6 active trials for LDX across 3 cities and 3 countries. The first study for LDX was performed in 2018. The trial, sponsored by Shire, involved 40 patients and completed its Phase 4 drug approval stage. Since 2018 years, 89 studies have been conducted."
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