Clinical trial NCT02659475 (phase 2, status: completed)
Conditions: binge eating disorder
ICD codes: F50.81
Drugs: phen/tpm er (qsymia®)
SMILES: CC(C)(N)CC1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          1. Men and women, ages of 18- 65 years, inclusive.

          2. Subjects will meet DSM-5 criteria for a diagnosis of BED. These are:

             A. Recurrent episodes of binge eating. An episode of binge eating is characterized by
             both of the following:

               -  Eating, in a discrete period of time (e.g., within a 2 hour period) an amount of
                  food that is definitely larger than most people would eat in a similar period of
                  time under similar conditions, and

               -  Sense of lack of control over the eating (e.g., a feeling that one cannot stop
                  eating or control what or how much one is eating)

             B. The binge eating episodes are associated with at least three of the following:

               -  eating much more rapidly than normal

               -  eating until uncomfortably full

               -  eating large amounts of food when not feeling physically hungry

               -  eating alone because of being embarrassed by how much one is eating

               -  feeling disgusted with oneself, depressed, or feeling very guilty after
                  overeating

             C. Marked distress regarding binge eating is present

             D. The binge eating occurs, on average, at least once a week for 3 months

             E. The binge eating is not associated with the recurrent use of inappropriate
             compensatory behavior as in bulimia nervosa and does not occur exclusively during the
             course of bulimia nervosa or anorexia nervosa

          3. Subjects will be obese (defined as a BMI ≥ 30 mg/kg2) or overweight (defined as BMI ≥
             27 kg/m2 or greater) in the presence of at least one weight-related comorbidity, such
             as hypertension, type 2 diabetes mellitus, or dyslipidemia.

          4. Subjects in treatment for a weight-related comorbidity (hypertension, type 2 diabetes
             mellitus, and/or dyslipidemia), must be on a stable medication regimen, defined as
             being on current dose of medication for at least 3 months prior to study enrollment.

        Exclusion Criteria:

          1. Current bulimia nervosa or anorexia nervosa.

          2. Women who are pregnant, lactating, or of childbearing potential who are not using
             adequate contraceptive measures. The following are considered to be adequate methods
             of birth control: 1. Intrauterine device (IUD); 2. Barrier protection; 3. A
             contraceptive implantation system (Norplant); 4. Oral contraceptive pills; 5. A
             surgically sterile partner; and 6. Abstinence. Women who are >2years post-menopausal
             or surgically-sterile are not considered of childbearing potential. All female
             subjects will have a negative pregnancy test prior to randomization.

          3. Subjects who are displaying clinically significant suicidality operationalized as a
             score ≥ 2 on item 9 of the Beck Depression Inventory (BDI) (21), or suicidal ideation
             on the Columbia-Suicide Severity Scale (C-SSRS) (22), or homicidality.

          4. Subjects who are receiving a psychological (e.g., supportive psychotherapy, cognitive
             behavior therapy, interpersonal therapy) or weight loss (e.g., Weight Watchers)
             intervention for BED or weight management that was begun within the 3 months before
             study entry. Subjects who are receiving psychotherapy that was initiated prior to 3
             months of the beginning of the study will be allowed to continue to receive their
             psychotherapy during the trial only if they agree to not make any changes in the
             frequency or nature of their psychotherapy during the course of the drug trial.

          5. A DSM-5 diagnosis of a substance-related or addictive disorder (except a
             tobacco-related disorder) within the 6 months prior to enrollment.

          6. A lifetime DSM-5 history of psychosis, mania or hypomania, or dementia.

          7. History of any psychiatric disorder which might interfere with a diagnostic
             assessment, treatment, or compliance.

          8. Clinically unstable medical disease, including cardiovascular, hepatic, renal,
             gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease. Subjects
             should be biochemically euthyroid to enter the study.

          9. Have a history of a structural cardiac abnormality, valvular cardiac disease,
             cardiomyopathy, serious heart rhythm abnormality, coronary artery disease, stroke, or
             other serious cardiovascular problem.

         10. History of seizure disorder, including clinically-significant febrile seizures in
             childhood.

         11. Subjects with glaucoma or hyperthyroidism.

         12. Have an ECG with significant arrhythmias or conduction abnormalities, which in the
             opinion of the physician investigator preclude study participation.

         13. Have clinically relevant abnormal laboratory results.

         14. Subjects requiring treatment with any drug which might interact adversely with or
             obscure the action of the study medication. This includes anti-obesity drugs,
             psychostimulants, wake-promoting agents, drugs with serotonergic properties,
             antidepressants, and antipsychotics.

         15. Subjects who have received any psychotropic medications (other than hypnotics) within
             four weeks prior to randomization, including monoamine oxidase inhibitors, tricyclics,
             selective serotonin reuptake inhibitors, antipsychotics, mood stabilizers, or
             psychostimulants.

         16. Subjects who have received investigational medications or depot neuroleptics within
             three months prior to randomization.

         17. Subjects who have a known allergy to PHEN/TPM ER (Qsymia®) or its constituents.

         18. Subjects with a urine drug screen positive for a drug that, in the opinion of the
             investigator, is being abused.