WHAT IS
CLINICAL RESEARCH?
BINGE EATING
DISORDER STUDY
HOW DO I
PARTICIPATE?






CONSUMING
YOUR THOUGHTS?
A guide to the SPD489
clinical research study


Binge eating is an eating disorder for which there are no approved medications.

That is why we are conducting a clinical research study to look at whether an investigational study medication can help people who have frequent binge episodes.

This website will tell you more about this study and clinical research studies in general.

To contact a study nurse,
please call 1-877-698-6719






    • WHAT ARE
      CLINICAL
      RESEARCH
      STUDIES
    • ?

    Clinical research studies help us find new medicines, improved versions of available medicines and new uses for available medicines. Without clinical research studies, we would not be able to improve treatments for patients all around the world.

    Clinical study participants provide valuable information that might help improve medical research and knowledge.


  • HOW WILL I BE PROTECTED
    DURING THE STUDY?

    There may be some risks and discomforts involved in
    taking part in any clinical research study. However,
    participant safety is the number one priority during
    every stage of the process.

    For more information about clinical research studies,
    please visit ClinicalTrials.gov.






WHAT TO EXPECT FOR THIS RESEARCH STUDY
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This clinical research study is looking at the effect of an investigational medication in individuals with binge eating disorder. In particular, we are looking for people aged 18 to 55 who have frequent binge episodes.

The study will last 39 weeks in total, during which time you will receive either the study medication or placebo (sugar pill) once every morning for 34 weeks. The placebo looks identical to the study medication but contains no active medicine.

Half of the participants in this study will take a placebo and half will take the study medication. This is so that we can compare outcomes in the two groups at the end of the study, and determine the effect of the study medication.

Whether you receive the investigational study medication or placebo will be decided randomly (by chance), and neither you nor the study team will be told to which treatment you have been assigned.

You will be asked to visit a study clinic every 1 to 2 weeks during the study to allow us to monitor your health and condition using assessments such as questionnaires, blood tests, vital sign examinations (e.g., blood pressure) and weight measurements. These assessments will be provided at no cost.






To find out whether you are eligible to take part in this study, please take our short pre-screening test. If you appear eligible, you will be invited to book an appointment with the study team to find out more about the study and have a screening test.

You will need to sign an informed consent form to show that you understand what the study involves and agree to take part.



HOW DO I PARTICIPATE?


Please answer all of the following questions to find out if you could be able to take part in this study. If you appear eligible for the study, you will be invited to book an appointment with the study team to find out more about the study.



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Questions  (please answer all questions)
1. I am between 18 and 55 years old.
Yes
No
2. Please indicate your gender.
Male
Female
3. Please indicate your height and weight. This will be used to calculate your Body Mass Index (BMI).
   Height (Feet)
   Height (Inches)
   Weight  (lbs)
4. In the past six months have you experienced repeated episodes when you ate larger than normal amounts of food and felt that you were unable to stop yourself?
Yes
No
5. Do you do any of the following after experiencing a binge eating episode?
  • I force myself to vomit after binge eating
  • I excessively exercise after binge eating
  • I starve myself after binge eating
  • None of the above
6. Within the last 3 months, have you started a program of treatment to control your binge eating?
Yes
No
7. Have you had bariatric surgery or other surgical procedures to facilitate weight loss?
Yes
No
8. Has a healthcare professional told you that you have any of the following medical conditions? [Note: Please check all that apply]
  • Post-traumatic stress disorder (PTSD)
  • Psychosis
  • Bipolar disorder
  • Attention deficit disorder/hyperactivity disorder (ADHD)
  • Autism
  • Seizures
  • Current diagnosis of Tourette’s Disorder
  • Significant head trauma
  • Dementia
  • Parkinson’s Disease
  • Glaucoma
  • Cardiovascular Disease
  • Coronary Artery Disease
  • Family history (immediate family) of significant cardiac problems
  • Moderate to Severe High Blood Pressure (defined as resting sitting systolic blood pressure >139mmHg or diastolic blood pressure >89mmHg.)
  • Type 1 or 2 Diabetes
  • Is there any other medical condition that you have which has not been specified (please specify in next question)
  • None of the above
9. Do you have a doctor’s diagnosis of major depressive disorder?
Yes
No
10. Have you ever attempted suicide?
Yes
No
11. Do you have a history of substance abuse or dependence within the past 6 months?
Yes
No
12. Have you participated in any clinical research study within the past 30 days?
Yes
No




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