Clinical Trials Logo

Clinical Trial Summary

The goal of this project is to evaluate the effectiveness and tolerability of the novel weight management medication PHEN/TPM ER (Qsymia®)along with nutritional and lifestyle modification counseling in the treatment of binge eating disorder (BED) in overweight or obese individuals.


Clinical Trial Description

This is an exploratory open-label trial of PHEN/TPM ER (Qsymia®) in BED. It is hypothesized that PHEN/TPM ER (Qsymia®) will be an effective, safe, and well tolerated treatment for BED and propose to conduct a 1-site, 12-week, open-label, flexible dose study of PHEN/TPM ER (Qsymia®) in 10 outpatients, ages 18 through 65 years, with BED. It is also hypothesized that PHEN/TPM ER (Qsymia®) will reduce weight and binge eating behavior, and will be well tolerated. The primary objective is to show that PHEN/TPM ER (Qsymia®) along with nutritional and lifestyle modification counseling is effective in reducing weight in overweight or obese patients with BED. Secondary objectives are to show that PHEN/TPM ER (Qsymia®) is effective in reducing frequency of binge eating episodes and associated eating psychopathology and is safe and well tolerated in patients with BED. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02659475
Study type Interventional
Source Lindner Center of HOPE
Contact
Status Completed
Phase Phase 2
Start date September 2015
Completion date September 2016

See also
  Status Clinical Trial Phase
Withdrawn NCT02978742 - Evaluating and Implementing a Smartphone Application Treatment Program for Bulimia Nervosa and Binge Eating Disorder N/A
Recruiting NCT02659488 - Lisdexamfetamine in Binge Eating Disorder (BED): fMRI Effects Phase 2
Completed NCT00601653 - Effectiveness of Cognitive Behavioral Therapy Plus Nutritional Counseling in Promoting Weight Loss in People With Binge Eating Disorder N/A
Completed NCT02834299 - Dialectical Behavior Therapy Guided Self-Help for Binge Eating Disorder N/A
Completed NCT02553824 - FDA Approved Medication to Reduce Binge Eating and/or Purging Phase 1
Completed NCT02564588 - Dasotraline Binge Eating Disorder Study Phase 2/Phase 3
Completed NCT00307190 - Hormone Release and Stomach Disturbances in People With Binge Eating Disorder N/A
Completed NCT01718509 - SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder Phase 3
Completed NCT01718483 - SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder Phase 3
Completed NCT02503098 - Optimizing a Smartphone Application for Individuals With Eating Disorders N/A
Active, not recruiting NCT01837953 - Stepped Care for Binge Eating Disorder: Predicting Response to Minimal Intervention in a Randomized Controlled Trial N/A
Completed NCT01010789 - Armodafinil in Binge Eating Disorder (BED) Phase 3
Completed NCT01098435 - ALK33-101: A Study of RDC-0313 (ALKS 33) in Adults With Binge Eating Disorder Phase 2
Completed NCT01552759 - Appetite Hormones in Binge Eating Disorder N/A
Completed NCT00330655 - An Open-Label Trial of Memantine in the Treatment of Binge Eating Disorder Phase 4
Completed NCT01291173 - Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder Phase 2
Completed NCT03107026 - A Study to Evaluate a Drug (Dasotraline) on the Safety, Effectiveness and How Well the Body Tolerates it, in Adults With Moderate to Severe Binge Eating Disorder Phase 3
Completed NCT02079935 - Treatment of Eating Disorders by Physical Activity and Nutrition Counseling N/A
Completed NCT00277641 - Lamotrigine in the Treatment of Binge Eating Disorder Associated With Obesity Phase 3
Completed NCT00032760 - Meditation-Based Treatment for Binge Eating Disorder Phase 2/Phase 3