Pramipexole for Binge Eating Disorder

NCT01106053 | Withdrawn Phase 3

• 1 other identifier: NEDA-Pramipexole
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Binge Eating Disorder

Keywords

Binge eating disorder; Food craving; Obesity; Pramipexole; Mirapex; Binge

Outcome Measures

Primary Outcomes (1)

• Frequency of binge eating

  Baseline followed by weekly during the seven week protocol

Secondary Outcomes (3)

• 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

Study Arms (1)

Pramipexole

EXPERIMENTAL

Open-label trial of pramipexole.

Drug: Pramipexole

Interventions

Pramipexole DRUG

Pramipexole tablet titrated up to a maximum dosage of 0.5 mg three times daily (1.5 mg/day).

Also known as: Mirapex

Pramipexole

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuropsychiatric Research Institute, Fargo, North Dakota: lead

Related Links

• NRI website

MeSH Terms

Conditions

Binge-Eating Disorder; Obesity

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Kristine J Steffen, PharmD, PhD

  Neuropsychiatric Research Institute, Fargo, ND

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reseach Scientist

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 19, 2010
• Study Start: April 1, 2010
• Primary Completion: July 1, 2011
• Last Updated: May 6, 2013

Record last verified: 2013-05