FDA Approved Medication to Reduce Binge Eating and/or Purging

NCT02553824 | Completed Phase 1 DMC

• 1 other identifier: 31390
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This study will demonstrate the efficacy of Qsymia versus placebo in treating bulimia nervosa and binge eating disorder.

Conditions

Binge Eating Disorder; Bulimia Nervosa

Keywords

binge eating; bulimia nervosa; binge eating disorder; eating disorder treatment

Outcome Measures

Primary Outcomes (1)

• Frequency of binge eating episodes as measured by the Eating Disorder Examination Assessment

  The primary outcome is the frequency of binge episodes

  8.5 months

Secondary Outcomes (2)

• Frequency of binge eating episodes measured by the Eating Disorder Examination Assessment

  8.5 months

• Percentage of Abstinence from Binge Eating as Measured by the Eating Disorder Examination Assessment

  8.5 months

Study Arms (2)

Phentermine/Topiramate-First + Placebo

EXPERIMENTAL

Patients randomly assigned to this condition will receive the study medication first, have a 2 week washout, and then crossover to receive the control medication/placebo

Drug: Phentermine/Topiramate-First; Drug: Placebo

Placebo-First + Phentermine/Topiramate

PLACEBO COMPARATOR

Patients randomly assigned to this condition will receive the control medication (placebo) first followed by a 2 week washout, and then receive the study medication.

Drug: Phentermine/Topiramate-First; Drug: Placebo

Interventions

Phentermine/Topiramate-First DRUG

Patients randomly assigned to this Arm will have a 4 week ramp up period (in which doses will be increased, as tolerated, starting from 3.75 mg/23 mg, 7.5 mg/46 mg ,11.25 mg/69 mg , 15 mg/92 mg taken once daily in the morning. For the final 8 weeks, participants will take the 15mg/92 mg (or highest dose tolerated). Then will have a 2 week washout followed by a crossover to 12 weeks of control medication/ placebo.

Also known as: Qsymia

Phentermine/Topiramate-First + Placebo; Placebo-First + Phentermine/Topiramate

Placebo DRUG

Patients randomly assigned to this Arm will have begin with 12 weeks of placebo followed by a 2 week washout. They will then crossover to Qsymia and receive a 4 week ramp up period (in which doses will be increased, as tolerated, starting from 3.75 mg/23 mg, 7.5 mg/46 mg ,11.25 mg/69 mg , 15 mg/92 mg taken once daily in the morning. For the final 8 weeks, participants will take the 15mg/92 mg (or highest dose tolerated).

Also known as: Placebo-First

Phentermine/Topiramate-First + Placebo; Placebo-First + Phentermine/Topiramate

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Must meet Diagnostic and Statistical Manual -Edition 5 criteria for bulimia or binge eating disorder, which has not responded to prior treatment
• Men and women between the ages of 18-60
• Must be at least normal weight (i.e. body mass index at least 21.0 or greater)
• If female of child-bearing potential, the participant must have an initial negative pregnancy test and be taking adequate birth control
• must be medically stable with no new diagnoses (medical, surgical, or psychiatric) within the past 6 months
• Must live close enough or be within commute distance of study site (Stanford, CA) to be able to comply with study visits, treatment plans, and blood draws and other possible assessments (i.e. EKG)

You may not qualify if:

• Any patient with bipolar disease or schizophrenia or any patient taking a mood stabilizer or antipsychotic medication within the past 3 months
• Any patient with current or past history of anorexia nervosa (i.e., with a Body mass index of \< 17.5).
• Any patient with prior (within 30 days) use of Over The Counter (OTC) weight-reducing agents, herbal preparations
• Any patient who has been prescribed a medication for weight loss within the past 3 months
• Any psychological weight-loss interventions (i.e., Weight Watchers, Jenny Craig) in which patient has lost weight over the past month (unless willing to discontinue).
• Any patient currently in therapy with a psychostimulant or who has used a psychostimulant within the past 6 months
• Any patient with known sensitivity to phentermine or topiramate
• Any patient who has had a change in thyroid, psychiatric, or blood pressure medications within the past one month
• Any patient who is taking a potassium-wasting diuretic
• Any patient who is on a carbonic anhydrase inhibitor such as zonisamide acetazolamide, or dichlorphenamide
• Any diabetic who is taking insulin or an insulin secretagogue
• Any patient with liver enzymes at baseline greater than three times the upper limit of normal
• Any patient with a baseline potassium of less than 3.0 millequivalent/Liter. Patients with baseline potassium levels between 3.0-3.5 miliEquivalents/Liter will be encouraged to ingest high potassium foods such as bananas, oranges, or tomato juice daily during the study
• Any patient with abnormal baseline thyroid test or with a Thyroid Stimulating Hormone (TSH) greater than 1.5 times the upper limit of normal
• Any patient who is unwilling or expresses uncertainty about being able to refrain from daily alcohol use (even if at moderate levels) or illegal drugs while taking the study medication.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford School of Medicine, Psychiatry and Behavioral Sciences

Stanford, California, 94305, United States

Location

Related Publications (2)

• Safer DL, Adler S, Dalai SS, Bentley JP, Toyama H, Pajarito S, Najarian T. A randomized, placebo-controlled crossover trial of phentermine-topiramate ER in patients with binge-eating disorder and bulimia nervosa. Int J Eat Disord. 2020 Feb;53(2):266-277. doi: 10.1002/eat.23192. Epub 2019 Nov 13.

  PMID: 31721257 DERIVED

• Dalai SS, Adler S, Najarian T, Safer DL. Study protocol and rationale for a randomized double-blinded crossover trial of phentermine-topiramate ER versus placebo to treat binge eating disorder and bulimia nervosa. Contemp Clin Trials. 2018 Jan;64:173-178. doi: 10.1016/j.cct.2017.10.007. Epub 2017 Oct 14.

  PMID: 29038069 DERIVED

MeSH Terms

Conditions

Binge-Eating Disorder; Bulimia Nervosa; Bulimia

Interventions

Phentermine; Qsymia

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Debra L Safer, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Sarah Adler, PsyD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Shebani Sethi, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: September 18, 2015
• Study Start: October 30, 2015
• Primary Completion: February 23, 2017
• Study Completion: April 15, 2017
• Last Updated: May 14, 2018

Record last verified: 2018-05

Locations

US (1)