NCT01868204

Brief Summary

Adoption, twin and family studies have reported that obesity has a strong heritable component and in particular, it has been suggested that BMI in adults is due to genetic influence rather than shared family environment. Binge eating in obese patients was described. Therefore, it has been proposed that binge eating disorder (BED) may contribute to obesity in some individuals. Pharmacological studies reported that topiramate plays an important role in the treatment of binge eating disorder. It has been observed improvement of co-occurring binge eating disorder in patients receiving topiramate for treatment of mood disorders. In addition, topiramate was associated with anorexia and weight loss in clinical trials with epilepsy patients. Also, topiramate has been demonstrated efficacy in pilot and controlled studies for binge eating disorder (BED) associated with obesity. Genetic studies will be important to elucidate the mechanism by which putative susceptibility variation in candidate genes influences in pharmacological improvement of binge eating disorder in obese patients treated with topiramate. Connecting drug response with relevant functional DNA variants and differences in brain regions represents the ultimate goal for pharmacogenetic research playing an important role in advancing this understanding. The use of brain imaging combined with genetics can aid in understanding the pathophysiological mechanism of the disease. Additionally, brain imaging has the ability to bridge between preclinical research and human pharmacological studies. This will be a naturalistic clinical study designed to analyze the effect of genetic variants and neurofunctional brain areas associated with food craving in patients with obesity and binge eating disorder responders to topiramate. Hypothesis: The use of topiramate in obese subjects with binge eating disorder is associated with a differential gene variants and different activation brain areas in subjects that showed a reduction of food craving and weight lost.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

June 4, 2013

Status Verified

May 1, 2013

Enrollment Period

6 months

First QC Date

May 30, 2013

Last Update Submit

June 3, 2013

Conditions

ObesityBinge Eating Disorder

Keywords

ObesityBinge eating disorderPharmacogeneticFood cravingBrain areasTopiramate

Outcome Measures

Primary Outcomes (1)

  • Treatment efficacy to topiramate in obese patients with binge eating disorder.

    Topiramate will be initiated in all subjects at a 25 mg/day dose QD followed by a weekly increase of 25 mg/day and titrated until meaningful clinical response is obtained on binge episodes weekly frequency, binge/days weekly frequency. Meaningful clinical response is defined as a reduction to at least 50% on this parameter taking into account each individual's basal frequencies of binge and food craving. Maximum dose will be set at 400 mg/day (Arnone et al., 2005; McElroy et al., 2003; Shapira et al., 2000).

    6 weeks

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

This will be a single-center study that will seek to recruit 60 obese subjects with binge eating disorder who started taking Topiramate. Eligible male or female subjects, from or referred to, the Eating Disorder Clinic will be invited to participate in the study. Obesity will be defined as having a body mass index ≥ 30 kg/m2.

You may qualify if:

  • Patients of Eating Disorders Clinic with a diagnosis of Bulimia Nervosa, Eating Disorders Not Otherwise Specified 3 and 6 with Binge Eating Disorder according to research criteria in Diagnostic and Statistical of Mental Disorders, version IV revised, who started taking Topiramate.
  • Probands with diagnosis of obesity (BMI ≥30 kg/m2- 40 kg/m2).
  • Capable to give written informed consent.
  • Age of 18 to 50 years at screening.
  • Maternal and paternal grandparents of Mexican descent.

You may not qualify if:

  • Subjects with alcohol or substance abuse or dependence.
  • Any psychiatric or medical disorder that requires inpatient treatment.
  • Psychosis or suicidal thoughts.
  • Abnormal blood chemistry.
  • Diabetes uncontrolled.
  • Metabolic acidosis.
  • Narrow-angle glaucoma.
  • Unstable hypothyroidism or hyperthyroidism.
  • Unable or unwilling to give a blood sample.
  • Pace-makers or metal implants that would preclude the functional Magnetic Resonance Image scan.
  • Pregnant or lactating women at screening or positive blood pregnancy test.
  • Presence of any epileptic disorder.
  • Subjects unable or unlikely to follow the protocol procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Psiquiatria Ramon de la Fuente Muñiz

México, D.f., 14370, Mexico

Location

Biospecimen

Retention: SAMPLES WITH DNA

Genomic DNA will be extracted from 5 ml of peripheral blood using standard method.

MeSH Terms

Conditions

ObesityBinge-Eating Disorder

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding and Eating DisordersMental Disorders

Study Officials

  • Beatriz E Camarena, PhD

    Instituto Nacional de Psiquiatria Dr. Ramon de la Fuente

    PRINCIPAL INVESTIGATOR

  • Alejandro Caballero, M.D.

    Instituto Nacional de Psiquiatria Dr. Ramon de la Fuente

    STUDY CHAIR

  • Juan J Cervantes, M.D.

    Instituto Nacional de Psiquiatria Dr. Ramon de la Fuente

    STUDY CHAIR

  • Griselda Flores, M.D.

    Instituto Nacional de Psiquiatria Dr. Ramon de la Fuente

    STUDY CHAIR

  • Sandra Hernandez, B,Sc.

    Instituto Nacional de Psiquiatria Dr. Ramon de la Fuente

    STUDY CHAIR

Central Study Contacts

Beatriz E Camarena, PhD

CONTACT

52(55)41605075camare@imp.edu.mx

Giselda Flores, M.D.

CONTACT

52(55)41605241grifloflo@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Science Investigator

Study Record Dates

First Submitted

May 30, 2013

First Posted

June 4, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

June 4, 2013

Record last verified: 2013-05

Locations

ME(1)