Pramipexole for Binge Eating Disorder

An Exploration of the Effects of the Dopamine Agonist Pramipexole on Binge Antecedants, Binge Frequency, and Weight in Binge Eating Disorder

This study is being conducted to evaluate the effects that the drug pramipexole has on mood, food craving, and other behaviors that may be related to binge eating disorder.

Study Overview

• Status: Withdrawn
• Conditions: Binge Eating Disorder
• Intervention / Treatment: Drug: Pramipexole

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female
• Age 18-50 years
• Women of child-bearing potential and males must agree to practice an accepted method of birth control. All women must have a negative pregnancy test at baseline.
• Good general health as demonstrated by history and physical examination.
• Body mass index of 30 kg/m2 or higher at the screening visit.
• Meet criteria for binge eating disorder as assessed through the SCID-1 and EDE.

Exclusion Criteria:

• Subjects with any unstable medical condition, or any current or past medical condition which in the opinion of the study physician and/or the principal investigator may increase the risks associated with pramipexole and study participation. Medical appropriateness will be determined through history and physical exam.
• Subjects with any current Axis I psychiatric diagnosis as determined through the Structured Clinical Interview for DSM-IV for Axis I disorders (SCID-1) interview (aside from BED).
• Subjects with a Hamilton Depression Rating Scale score greater than or equal to 12 at the screening visit.
• Subjects who report any history of hallucinations or delusions.
• Participants taking an antidepressant or other regularly used psychotropic medication which may confound the study results
• Subjects with any current or history of an impulse control spectrum disorder, other than binge eating disorder,(such as pathological gambling, compulsive shopping, etc.) at screening as determined by the Structured Clinical Interview for DSM-IV Impulse Control Module.
• Subjects with any history of suicide attempts or current suicidal ideations.
• Subjects that have used tobacco products on a routine basis within the past six months.
• Subjects enrolled in any formal treatment programs or research protocols for binge eating disorder at present, or within the past 30 days.
• Subjects routinely taking any medication known to produce weight change (ex. olanzapine, amitriptyline, steroid medications, etc., other than oral contraceptives, stable thyroid replacement drugs, etc.), or medications with drug-drug interactions with pramipexole.
• Subjects who are currently breast-feeding.
• Subjects who have participated in an investigational drug trial in the past 30 days.
• Subjects who meet DSM IV-TR criteria for alcohol or drug abuse in the past year.
• Subjects with an allergy to pramipexole or tablet constituents.
• Subjects with hepatic dysfunction as determined through a hepatic panel obtained at the screening visit.
• Subjects with an elevated blood pressure or pulse at screening (140/90 mmHg or above or pulse of greater than 100 beats/minute after being seated and stationary for at least five minutes, or as determined at the discretion of the study physician and/or principal investigator) or history of serious cardiac events (myocardial infarction, arrhythmia, stroke, etc).
• Subjects with a history of renal dysfunction or with a creatinine clearance of less than 60 ml/min based upon a serum creatinine obtained during screening and as calculated with the Cockroft and Gault equation.
• Subjects with a positive urine drug screen.
• Any participant with Parkinson's disease or symptoms suggestive of probable Parkinson's disease.
• Subjects who have an Epworth Sleep Scale (ESS) score of >7 at screening. ESS scores > 7 have been associated with an increased risk of sleep attacks (Plowman et al., 2005).
• Any participant who demonstrates clinically significant orthostatic blood pressure changes or is symptomatic during the screening visit, as defined under "orthostatic blood pressure monitoring."
• History of bariatric surgery.
• Participants who report a history of obstructive sleep apnea, excessive fatigue, or any sleep disorder which in the opinion of the principal investigator or study medical personnel would increase the participant's risk of experiencing excessive somnolence with pramipexole.
• Participant has had a change in medication regimen in the last month (dose, starting a new medication, or stopping a medication).
• Participant is employed by, or has an immediate family member employed by NRI.
• Participant has participated in a formal weight loss program in the last month (e.g. Weight Watchers, Jenny Craig, etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pramipexole; Open-label trial of pramipexole.	Drug: Pramipexole; Pramipexole tablet titrated up to a maximum dosage of 0.5 mg three times daily (1.5 mg/day).; Other Names: Mirapex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of binge eating	Baseline followed by weekly during the seven week protocol

Secondary Outcome Measures

Outcome Measure	Time Frame
Body weight	Baseline followed by weekly during the seven week protocol
Frequency and extent of craving for food using validated instruments	Baseline followed by weekly during the seven week protocol
Assessment of mood ratings using a validated instrument	Baseline followed by weekly during the seven week protocol

Collaborators and Investigators

• Sponsor: Neuropsychiatric Research Institute, Fargo, North Dakota
• Investigators: Principal Investigator: Kristine J Steffen, PharmD, PhD, Neuropsychiatric Research Institute, Fargo, ND

Publications and helpful links

Helpful Links

• NRI website

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): July 1, 2011

Study Registration Dates

• First Submitted: April 15, 2010
• First Submitted That Met QC Criteria: April 15, 2010
• First Posted (ESTIMATE): April 19, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): May 6, 2013
• Last Update Submitted That Met QC Criteria: May 3, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Obesity; Pramipexole; Binge eating disorder; Food craving; Mirapex; Binge
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Signs and Symptoms, Digestive; Hyperphagia; Disease; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Protective Agents; Dopamine Agonists; Dopamine Agents; Antioxidants; Antiparkinson Agents; Anti-Dyskinesia Agents; Pramipexole
• Other Study ID Numbers: NEDA-Pramipexole