Clinical trial NCT01990755: Neurobiology of Eating Disorders Treatments
Official title: Lack of Efficacy of Psychological and Pharmacological Treatments of Eating Disorders: Neurobiological Background
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Bulimia Nervosa
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
Collaborators: name: University of Milan
First posted: 2013-11-21
Enrollment: 112
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background. Treatments of eating disorders result too often in partial psychological and physical remission, chronic course, dropout, relapse and death, with no fully known explanations for this failure. In order to clarify this problem, we conducted a three branches study to identify the biochemical background of cognitive-behavioral psychotherapy (CBT), individual psychology brief psychotherapy (IBPP), and psychotherapy-pharmacotherapy with CBT+olanzapine in anorexics (AN) and bulimics (BN) by measuring the levels of plasma homovanillic acid (HVA) for dopamine secretion, plasma 3-methoxy-4-hydroxy-phenylglycol (MHPG) for noradrenalin secretion, and platelet \[3 Hydrogen\]-Paroxetine-binding Bmax and Kd for serotonin transporter function. The data were then compared with psychopathological and physical alterations. Methods. Branch 1 investigated the effects of 4 months of CBT on plasma HVA, MHPG and \[3 Hydrogen\]-Par-binding in 14 AN-restricted, 14 AN-bingeing/purging, and 22 BN inpatients. Branch 2 investigated the effects of 4 months of IBPP on plasma HVA in 15 AN and 17 BN outpatients. Branch 3 investigated the effect of 3 months of CBT+olanzapine (5 mg/day) in 30 AN outpatients. The data are analyzed using one-way ANOVA for repeated measures for the changes between basal and post-treatment biological and psychological parameters, two-way ANOVA for repeated measures for the differences in the psychobiological data in the 3 groups, Spearman's test for the correlations between basal and final changes in the psychological and biological scores.


Eligibility criteria: Inclusion Criteria:

* eating disorders full diagnosis according to Diagnostic and Statistical Manual (DSM-IV)
* age between 15 and 35
* female gender

Exclusion Criteria:

* associated major psychiatric problems
* mental retardation

Primary outcomes:
measure: change in brain secretion of Dopamine at 6 months
timeFrame: 6 months
measure: change in brain secretion of Noradrenaline at 6 months
timeFrame: 6 months
measure: change in brain secretion of serotonin at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Eating Psychopathology improvement after treatments at 6 months
timeFrame: 6 months
measure: Depressive Psychopathology improvement after 6 months
timeFrame: 6 months
measure: Anxiety improvement after 6 months
timeFrame: 6 months
measure: Impulsiveness improvement after 6 months
timeFrame: 6 months
measure: Self-rated Biochemical improvement after 6 months
timeFrame: 6 months
measure: Personality improvement after 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Garda
country: Italy
facility: Villa Garda
state: Veneto
Study officials:
affiliation: University of Torino
name: Federico Amianto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Torino
name: Secondo Fassino, MD
role: STUDY_CHAIR
References:
citation: Brambilla F, Amianto F, Dalle Grave R, Fassino S. Lack of efficacy of psychological and pharmacological treatments of disorders of eating behavior: neurobiological background. BMC Psychiatry. 2014 Dec 24;14:376. doi: 10.1186/s12888-014-0376-7.