Patients with Anorexia Nervosa and Healthy Controls
Conditions
Interventions
Trade Name: Tiacur®
Pharmaceutical Form: Injection
Sponsors
Dept of Psychiatry, Umeå University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female, 18-65 years of age, who has given written con-sent for his/her participation to the study¸ Women of Childbearing Capacity (WOCBC) only if willing to comply with effective contra-ception methods during the course of the trial. Acceptable methods are such as oral contraceptives, contraceptive patches, contracep-tive implant, vaginal contraceptive, double-barrier methods (for example, condom and spermicide), intrauterine device (IUD), hor-monal IUD 2) A diagnosis of Anorexia Nervosa. An age of 18 or older. A verified duration of symptoms of at least 3 months. A minimum BMI of 13 and a BMI less than 19. A written consent to participate in the study and to adhere to the study protocol, a willingness to start treatment as usual and to receive three intramuscular injections of 100mg thiamine. 3) Normal-weight Controls. An age of 18 or older. No current severe somatic or psychiatric illness. A written consent to participate in the study and to adhere to the study protocol and a willingness to receive three intramuscular injections with thiamine. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Short life expectancy due to other comorbidity 2) Contraindication for or otherwise not compliant with the thiamine injections or other investigations 3) Documented allergy or intolerance to study drug 4) Severe psychiatric condition or other reason that jeopardize compliance with follow up. 5) On fertile females, pregnancy assessed by anamnesis and pregnancy test 6) Current high-dose treatment with thiamine, or recent (within the last month), high-dose treatment with thiamine. 7) Current diagnosis of alcoholism, drug abuse or mental retardation. A current prescription of atypical neuroleptics or benzodiaz-epines. Positive drug screening. 7) Current diagnosis of alcoholism, drug abuse or mental retardation. A current prescription of atypical neurolep-tics or benzodiazepines. Positive drug-screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effects of thiamine on weight in Anorexia Nervosa and controls and the tolerability of thiamine treatment.;Secondary Objective: a) To study if addition of thiamine treatment has beneficial neurocognitive effects in patients with Anorexia Nervosa. b) To study thiamine status in patients with Anorexia Nervosa at inclusion to study, and after six weeks of treatment. c) An explorative study of biochemical and genetic markers in relation to Anorexia Nervosa, with a special focus on mitochondrial DNA and factors related to thiamine regulation of glucose metabolism. ;Primary end point(s): The primary endpoint is to evaluate the treatment-effect of thiamine in Anorexia Nervosa. The main outcome is weight-gain, as measured by increase in kilograms, which is a fairly standard way of evaluating the efficacy of treatment for anorexia. ;Timepoint(s) of evaluation of this end point: Weight-gain recorded closest to day 42 of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) Change in appetite. Based on scores on the “appetite”-item in MADRS-s, at start of study and after 6 weeks. b) Change in mood and anxiety, as measured by total MADRS-s-score at inclusion to study and after 6 weeks. c) Change in neurocognitive function, with a specific focus on learning and memory. d) Thiamine levels and thiamine metabolism in patients having been treated for Anorexia Nervosa. Measure-ments of serum thiamine levels and transketolase-activity at inclusion and after 6 weeks. e) Epigenetic effects of treatment with thiamine and treatment-as-usual for Anorexia Nervosa. Analysis of DNA and mitochondrial DNA associated with the uptake and function of thiamine. f) Effects of treatment on lipids, cortisol and oxysterols. g) Compliance to treatment o Adverse events o Compliance to drug prescription ;Timepoint(s) of evaluation of this end point: a) At start of study and after 6 weeks. b) At inclusion to study and after 6 weeks. c) At inclusion to study and after 6 weeks. d) At inclusion to study and after 6 weeks. e) At inclusion to study. f) At inclusion to study and after 6 weeks g) From the time a patient receives the first injection until up to 30 day follow-up period after completion of the trial | — |
Countries
Sweden
Contacts
Public ContactPeter Asellus
Dept of Psychiatry, Umeå University Hospital
Outcome results
None listed