Disulfiram in the treatment of eating disorders

Conditions: Obesity and binge eating disorder
MedDRA version: 14.1Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2012-004951-35-IT

Lead Sponsor: AZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1) obesity (BMI = 30); 2) diagnosis of BED according to the diagnostic criteria of the DSM-IV-TR (APA, 2000); 3) aged between 18 and 65 years; 4) residence throughout the period of the study in a location that allows compliance with scheduled visits; 5) be able to discernment, to understand the purposes of the study, provide appropriate behaviors for its implementation, agree on the protocol on the participation in the study and sign an informed consent 6) normal liver and kidney function demonstrated by blood tests performed within the 3 months prior to enrollment (such as complete blood count, blood glucose, BUN, creatinine, ALT, AST, GGT, serum protein)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Diagnosis of dependence and / or current or lifetime alcohol abuse according to the DSM-IV-TR; 2) diagnosis of a psychotic disorder current or lifetime according to the diagnostic criteria of the DSM-IV-TR; 3) a diagnosis of other medical disorders (severe heart disease, diabetes, cirrhosis, hypothyroidism and / or renal dysfunction) or psychiatric disorder (severe mood disorders, suicidal ideation current or past) that, based on medical judgment, may constitute a danger to the participation of the patient in the study or limit compliance; 4) for women of childbearing potential: pregnant, lactating or non-use of contraceptive methods (oral contraceptives or depot, barrier methods such as condoms or spiral); 5) hypersensitivity to disulfiram; 6) start of a psychotherapy treatment for BED less than 3 months; 7) start of drug therapy with psychoactive drugs (antidepressants, anxiolytics, etc..) By a period of less than one month

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy and handling of disulfiram in the treatment of obese patients with binge eating disorder;Secondary Objective: -;Primary end point(s): 1) frequency of episodes of binge; 2) body weight; 3) possible occurrence of side effects; 4) severity of craving for food; 5) quality of life;Timepoint(s) of evaluation of this end point: 16 weeks

Secondary Outcome Measures