Neurobiology of Eating Disorders Treatments

NCT01990755 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2013-11-21

No results posted yet for this study

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.

Conditions

  • Anorexia Nervosa
  • Bulimia Nervosa

Interventions

BEHAVIORAL

CBT (Cognitive Behavioral Therapy)

It is a worldwide known form of psychotherapy for eating disorders

OTHER

IBPP (individual psychology brief psychotherapy)

It is a worldwide known form of psychotherapy for eating disorders

DRUG

CBT + OLANZAPINE

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

DIETARY_SUPPLEMENT

nutritional rehabilitation

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

DRUG

delorazepam

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

Sponsors & Collaborators

  • University of Milan

    collaborator OTHER
  • University of Turin, Italy

    lead OTHER

Principal Investigators

  • Federico Amianto, MD, PhD · University of Torino

  • Secondo Fassino, MD · University of Torino

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • Italy

Study Locations

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Read the full study record

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View NCT01990755 on ClinicalTrials.gov