Obesity and binge eating disorder MedDRA version: 14.1 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: ETILTOX*30CPR 200MG
Pharmaceutical Form: Tablet
INN or Proposed INN: DISULFIRAM
CAS Number: 97-77-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Sponsors
AZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARI
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): -;Timepoint(s) of evaluation of this end point: - | — |
Countries
Italy
Contacts
Public ContactSezione di Neuroscienze
Dipartimento di Scienze Biomediche
Outcome results
None listed