Pharmacogenetic and Neurofunctional Brain Areas Study in Obese Patients With Binge Eating Disorder

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Sponsor:
Information provided by (Responsible Party):
Beatriz Elena Camarena Medellin, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
ClinicalTrials.gov Identifier:
NCT01868204
First received: May 30, 2013
Last updated: June 3, 2013
Last verified: May 2013
  Purpose

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.


Condition
Obesity
Binge Eating Disorder

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Pharmacogenetic Study of Neurofunctional Brain Areas Related to Food Craving in Obese Patients With Binge Eating Disorder Treated With Topiramate

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente:

Primary Outcome Measures:
  • Treatment efficacy to topiramate in obese patients with binge eating disorder. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    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).


Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 60
Study Start Date: June 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.

Criteria

Inclusion Criteria:

  1. 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.
  2. Probands with diagnosis of obesity (BMI ≥30 kg/m2- 40 kg/m2).
  3. Capable to give written informed consent.
  4. Age of 18 to 50 years at screening.
  5. Maternal and paternal grandparents of Mexican descent.
  6. Probands without psychopharmacological treatment (including anticonvulsants) at least 4 weeks before inclusion.

Exclusion Criteria:

  1. Subjects with alcohol or substance abuse or dependence.
  2. Any psychiatric or medical disorder that requires inpatient treatment.
  3. Psychosis or suicidal thoughts.
  4. Abnormal blood chemistry.
  5. Diabetes uncontrolled.
  6. Unstable hypertension or difficult to control (criterion 7 of inclusion section).
  7. Metabolic acidosis.
  8. Narrow-angle glaucoma.
  9. Unstable hypothyroidism or hyperthyroidism.
  10. Unable or unwilling to give a blood sample.
  11. Pace-makers or metal implants that would preclude the functional Magnetic Resonance Image scan.
  12. Pregnant or lactating women at screening or positive blood pregnancy test.
  13. Presence of any epileptic disorder.
  14. Subjects unable or unlikely to follow the protocol procedures.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01868204

Contacts
Contact: Beatriz E Camarena, PhD 52(55)41605075 camare@imp.edu.mx
Contact: Giselda Flores, M.D. 52(55)41605241 grifloflo@hotmail.com

Locations
Mexico
Instituto Nacional de Psiquiatria Ramon de la Fuente Muñiz Not yet recruiting
Mexico, D.f., Mexico, 14370
Contact: Beatriz E Camarena, PhD    52(55)41605075    camare@imp.edu.mx   
Contact: Griselda Flores, M.D.    52(55)41605241    grifloflo@hotmail.com   
Principal Investigator: Beatriz E Camarena, PhD         
Sponsors and Collaborators
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Investigators
Principal Investigator: Beatriz E Camarena, PhD Instituto Nacional de Psiquiatria Dr. Ramon de la Fuente
Study Chair: 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
  More Information

No publications provided

Responsible Party: Beatriz Elena Camarena Medellin, Medical Science Investigator, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
ClinicalTrials.gov Identifier: NCT01868204     History of Changes
Other Study ID Numbers: TOPMATOBE3002, IC092024.0
Study First Received: May 30, 2013
Last Updated: June 3, 2013
Health Authority: Mexico: Secretaria de Salud

Keywords provided by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente:
Obesity
Binge eating disorder
Pharmacogenetic
Food craving
Brain areas
Topiramate

Additional relevant MeSH terms:
Binge-Eating Disorder
Bulimia
Disease
Eating Disorders
Obesity
Body Weight
Hyperphagia
Mental Disorders
Nutrition Disorders
Overnutrition
Overweight
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 23, 2014