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Neurobiology of Eating Disorders Treatments

Lack of Efficacy of Psychological and Pharmacological Treatments of Eating Disorders: Neurobiological Background

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01990755
Acronym
NEDT
Enrollment
112
Registered
2013-11-21
Start date
2010-05-31
Completion date
2013-05-31
Last updated
2013-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa, Bulimia Nervosa

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.

Interventions

It is a worldwide known form of psychotherapy for eating disorders

OTHERIBPP (individual psychology brief psychotherapy)

It is a worldwide known form of psychotherapy for eating disorders

DRUGCBT + OLANZAPINE

It is a worldwide known form of psychotherapy for eating disorders associated with a new antipsychotic with good efficacy on anorexia nervosa

DIETARY_SUPPLEMENTnutritional rehabilitation

all patients were followed-up monthly with nutritionist and dietitian visits

DRUGdelorazepam

all patients were followed-up with psychiatric visits with symptomatic drug administration (tranquillizer: delorazepam) where necessary

Sponsors

University of Milan
CollaboratorOTHER
University of Turin, Italy
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 35 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in brain secretion of Dopamine at 6 months6 monthsplasma homovanillic acid (HVA) measured before and after the therapeutic intervention in each branch.
change in brain secretion of Noradrenaline at 6 months6 monthsplasma 3-methoxy-4-hydroxyphenylglycol (MHPG) measured before and after the therapeutic intervention in each branch
change in brain secretion of serotonin at 6 months6 monthsthe platelet paroxetine binding (\[3 Hydrogen\]-Par-binding): Bmax (maximum binding capacity) and Kd (dissociation constant) measured before and after the therapeutic intervention in each branch.

Secondary

MeasureTime frameDescription
Impulsiveness improvement after 6 months6 monthsBarratt Impulsiveness Scale
Eating Psychopathology improvement after treatments at 6 months6 monthsEating Disorders Examination-12 (EDE 12)
Personality improvement after 6 months6 monthsTemperament and Character Inventory (TCI)
Self-rated Biochemical improvement after 6 months6 monthsRosenberg Self-Biochemical Scale
Depressive Psychopathology improvement after 6 months6 monthsBeck Depression Inventory (BDI)
Anxiety improvement after 6 months6 monthsState-Trait Anxiety Index (STAI) Form-Y-1

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026