Pharmacogenetic and Neurofunctional Brain Areas Study in Obese Patients With Binge Eating Disorder
|ClinicalTrials.gov Identifier: NCT01868204|
Recruitment Status : Unknown
Verified May 2013 by Beatriz Elena Camarena Medellin, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente.
Recruitment status was: Not yet recruiting
First Posted : June 4, 2013
Last Update Posted : June 4, 2013
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 or disease|
|Obesity Binge Eating Disorder|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Pharmacogenetic Study of Neurofunctional Brain Areas Related to Food Craving in Obese Patients With Binge Eating Disorder Treated With Topiramate|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||March 2014|
- Treatment efficacy to topiramate in obese patients with binge eating disorder. [ Time Frame: 6 weeks ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868204
|Contact: Beatriz E Camarena, PhD||52(55)email@example.com|
|Contact: Giselda Flores, M.D.||52(55)firstname.lastname@example.org|
|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 email@example.com|
|Contact: Griselda Flores, M.D. 52(55)41605241 firstname.lastname@example.org|
|Principal Investigator: Beatriz E Camarena, PhD|
|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|