The purpose of this research study is to determine the efficacy (how well it works),
tolerability and safety of acomprosate compared with placebo in patients with binge eating
disorder.
Inclusion Criteria:
- Subjects will meet the DSM-IV (1) criteria for a diagnosis of binge eating disorder
(BED) for at least the last 6 months. The DSM-IV criteria are as follows:
- Recurrent episodes of binge eating. An episode of binge eating is characterized
by both of the following: eating, in a discrete period of time (eg, within any
two 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 a sense of
lack of control over eating during the episode (eg, a feeling that one cannot
stop eating or control what or how much one is eating).
- 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.
- Marked distress regarding binge eating.
- The binge eating occurs, on average, at least two days a week for six months.
- The episodes of binge eating do not occur exclusively during the course of
bulimia nervosa or anorexia nervosa.
- In addition, subjects will report at least 3 binge eating episodes per week for the
last 6 months prior to randomization
- Weight > 85% of the midpoint of ideal body weight for their height. (According to the
Metropolitan Height/Weight table.) The subject population is expected to include both
normal weight and obese individuals (although the majority of subjects are expected
to be overweight).
- Men or women, between the ages of 18 and 65. The subject population is expected to
be predominantly made up of women.
Exclusion Criteria:
- Have concurrent symptoms of bulimia nervosa or anorexia nervosa, including weight
loss to at least 15% below the Metropolitan Height/Weight tables.
- Women who are pregnant, lactating, or of childbearing potential who are not using
adequate contraceptive measures. (All women of childbearing potential will have a
negative pregnancy test before entering the study).
- Patients who are displaying clinically significant suicidality or homicidality.
- Patients who have received psychotherapy or behavioral therapy from a mental health
professional as a part of previous treatment for BED for at least 3 months prior to
randomization.
- A DSM-IV diagnosis of substance abuse or dependence (except nicotine abuse or
dependence) within the 6 months prior to randomization.
- A lifetime DSM-IV history of psychosis, mania or hypomania, or dementia.
- History of any psychiatric and personality disorder (eg, schizotypal and borderline)
which might interfere with a diagnostic assessment, treatment, or compliance.
- Clinically unstable medical disease, including cardiovascular, hepatic, renal,
gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease which
could interfere with diagnosis, treatment, or assessment of BED. Patients should be
biochemically euthyroid to enter the study.
- History of seizures, including febrile seizures in childhood.
- Patients requiring treatment with any drug which might interact adversely with or
obscure the action of the study medication.
- Clinically relevant abnormal laboratory results, specifically including hypokalemia.
- Patients who have received monoamine oxidase inhibitors, antipsychotics, lithium, or
fluoxetine within four weeks prior to randomization.
- Patients who have received other psychoactive medications (other than hypnotics)
within one week prior to randomization.
- Patients who have received investigational medications or depot neuroleptics within
three months prior to randomization.
- Patients previously enrolled in this study or have previously been treated with
acamprosate.
Anna Guerdjikova, PhD, Phone: 513-536-7021, Email: anna.guerdjikova@lindnercenter.org
